Comparison of Cortisol Pump With Standard Treatment for C... | NCT01859312

ID	Type	Description	Link
13-CH-0121	Other Identifier	National Institute of Child Health and Human Development

Status Module

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH

Description Module

Brief Summary

Background:

Congenital adrenal hyperplasia (CAH) is a genetic disorder of the adrenal gland. The adrenal gland is located in the abdomen and produces small amounts of hormones such as cortisol, aldosterone, and androgen. These hormones help control blood pressure, protect the body, and maintain good health, especially during development. People with CAH do not make enough cortisol and aldosterone, and make too much androgen. This can lead to serious medical problems. The standard treatment is to take pills that mimic the effects of cortisol and aldosterone. However, treatment with pills can have long-term side effects because of the higher doses needed, and may not work well for some people.
A possible new treatment for CAH is to use a pump to deliver cortisol under the skin. Similar pumps are often used to give insulin to people with diabetes. Researchers think that a cortisol pump might be able to help the body use the cortisol more effectively than taking pills. They want to compare the results of a cortisol pump and standard pill treatments for CAH.

Objectives:

- To compare the effectiveness of a cortisol pump with standard cortisol pill therapy for CAH.

Eligibility:

- Men and women at least 18 years of age who have CAH (see more details in Eligibility section below).

Design:

This study will involve four inpatient hospital stays at the National Institutes of Health in Bethesda, MD over 6 months (spaced 2 months apart). The first and last stays will last about 5 days. The second and third stays will last about 3 days.
Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
At the first study visit, participants will provide regular blood and urine samples. They will also have imaging studies. These studies will look at the bones, fat, and muscles in the abdomen and pelvis.
Participants will receive a cortisol pump during the first visit. They will be shown how to use the pump. They will also learn what to do, if they need to take extra "stress dose" cortisol pills.
At the second and third visits, the cortisol dose given with the pump will be adjusted as needed. Blood and urine samples will also be collected. No imaging studies are scheduled for these visits.
The last study visit will have the same tests as the first visit. Participants will be offered the chance to continue with the pump treatment for 1 more year, or go back to their standard pill treatment.

Study type: Interventional non-randomized trial

Official title: A Pilot Study Assessing the use of Continuous Subcutaneous Hydrocortisone Infusion In the Treatment of Congenital Adrenal Hyperplasia

Estimated enrollment: 8

Study Start Date: May 2013

Estimated Study Completion Date: December 2016

Sponsoring Institute: National Institute of Child Health and Human Development

<TAB>ELIGIBILITY

Inclusion criteria

Men and women 18 years of age or older with classic congenital adrenal hyperplasia (21-Hydroxylase deficiency)
High adrenal androgens in the blood, and
One or more of the following conditions: obesity, fatty liver, risk for diabetes, low bone mass, inability to tolerate cortisol pills

Exclusion criteria

Pregnancy
Breast feeding
Use of inhaled or oral steroids for diseases other than CAH
Use of estrogen-containing birth control pills
Use of medicines that cross-react with hydrocortisone
Use of stress dose steroids for illness during the last 30 days prior to joining the study

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Continuous Subcutaneous Hydrocortisone Infusion	Experimental	Enrolled participants with congenital adrenal hyperplasia (CAH) received continuous subcutaneous hydrocortisone (Solucortef) infusion (CSHI) via insulin pump (Medtronic) (MMT-722Na) to achieve near-physiologic cortisol replacement therapy. Participants were their own controls; participant's baseline outcomes/lab values while on conventional glucocorticoid therapy were compared to outcomes/lab values after 6 months of treatment using CSHI via insulin pump.	Drug: Hydrocortisone (Solucortef) Device: Insulin pump (Medtronic)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydrocortisone (Solucortef)	Drug	Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA). Total daily hydrocortisone dose was calculated based on the patient's estimated cortisol clearance. Rates were established to achieve peak and trough concentrations within the normal circadian cortisol range.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients With 17-OHP Levels Equal or Below 1,200 ng/dL at 0700	17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency	At baseline
Number of Patients With 17-OH Progesterone Levels Equal or Below 1,200 ng/dL at 0700	17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency	At 6 months

Secondary Outcomes

Measure	Description	Time Frame
Participants Mean Level of 17-OHP at 0700	17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency	At baseline
Participants Mean Level of 17-OHP at 0700

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:
Patients with known classic CAH due to 21-hydroxylase deficiency as evidenced by hormonal and genetic testing
Male or female patients 18 years or older
Females must have a negative pregnancy test initially and at all visits. Sexually active females must be using a medically acceptable method of contraception.
Patients with elevated adrenal androgens (defined as 17-OHP >1200 ng/dL and androstenedione >210 ng/dL)
One or more co-morbidities:<TAB>
Obesity [body mass index (BMI) greater than 30.0 kg/m(2)]
Fatty liver disease; assessed by AST/ALT liver enzyme ratio (AST to ALT ratio <1 (11)) liver ultrasound or MRI imaging (Steatosis score as previously described)
Low insulin sensitivity; assessed by the Homeostasis Model Assessment Insulin Resistance (HOMA-IR) method [HOMA-IR = insulin (micro U/ml) times glucose (mmol/L)/ 22.5]. Elevated HOMA-IR index is defined as >2.6 in adults17.
Osteopenia [bone mineral density by DEXA (at the spine, hip, or forearm) with T-score of -1 to -2.5) or osteoporosis (bone mineral density by DEXA (at the spine, hip, or forearm) with T-score of <-2.5] defined according to World Health Organization (WHO).
Glucocorticoid-related gastrointestinal side effects (nausea, vomiting, dyspepsia, anorexia, gastritis, peptic ulcer disease and gastric bleeding)

EXCLUSION CRITERIA:

Co-morbid conditions requiring daily administration of medications that induce hepatic enzymes or interfere with the metabolism of glucocorticoids
Females who are pregnant or lactating
Patients on inhaled or oral steroids given for reasons other than treatment of CAH
Women who have taken estrogen-containing oral contraceptive pills within 6 weeks of recruitment
Patients who required stress dose glucocorticoids for an illness within 4 weeks of recruitment
Patients who changed their glucocorticoid agent within 3 months of recruitment
Patients who underwent bilateral adrenalectomy
Co-morbid conditions that could interfere with the ability to comply to the protocol

Name	Affiliation	Role
Deborah P Merke, M.D.	National Institutes of Health Clinical Center (CC)	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
National Institutes of Health Clinical Center, 9000 Rockville Pike		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19223520	Background	Debono M, Ghobadi C, Rostami-Hodjegan A, Huatan H, Campbell MJ, Newell-Price J, Darzy K, Merke DP, Arlt W, Ross RJ. Modified-release hydrocortisone to provide circadian cortisol profiles. J Clin Endocrinol Metab. 2009 May;94(5):1548-54. doi: 10.1210/jc.2008-2380. Epub 2009 Feb 17.
22990093	Background	Finkielstain GP, Kim MS, Sinaii N, Nishitani M, Van Ryzin C, Hill SC, Reynolds JC, Hanna RM, Merke DP. Clinical characteristics of a cohort of 244 patients with congenital adrenal hyperplasia. J Clin Endocrinol Metab. 2012 Dec;97(12):4429-38. doi: 10.1210/jc.2012-2102. Epub 2012 Sep 18.

Label	URL
NIH Clinical Center Detailed Web Page	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Continuous Sub-Q Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) received continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to achieve near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Continuous Sub-Q Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000
Between 18 and 65 years	BG0008
>=65 years	BG000

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0005
Male	BG0003

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000
Not Hispanic or Latino	BG0008

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0005

Canada

Title	Measurements
	BG000

Phenotype

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Simple Virilizing (SV)	BG0002
Salt-wasting (SW)	BG0006

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Patients With 17-OHP Levels Equal or Below 1,200 ng/dL at 0700

17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency

Posted

Count of Participants

Participants

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG0008

Title

Denominators

Categories

Title	Measurements
	OG0000

Primary

Number of Patients With 17-OH Progesterone Levels Equal or Below 1,200 ng/dL at 0700

17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency

Posted

Count of Participants

Participants

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of 17-OHP at 0700

17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency

Posted

Mean

Standard Error

ng/dL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of 17-OHP at 0700

17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency

Posted

Mean

Standard Error

ng/dL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours

17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*mcg/dL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours

Posted

Mean

Standard Error

h*mcg/dL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500)

17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*mcg/dL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500)

17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*mcg/dL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300)

17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficienc. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*mcg/dL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300)

17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*mcg/dL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700)

17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*mcg/dL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700)

17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*mcg/dL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Androstenedione at 0700

Participants Mean Level of Androstenedione at 0700.

Posted

Mean

Standard Error

ng/dL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Androstenedione at 0700

Participants Mean Level of Androstenedione at 0700.

Posted

Mean

Standard Error

ng/dL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours

Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*mcg/dL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours

Participants Mean Level of Androstenedione area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*mcg/dL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500)

Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*mcg/dL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500)

Posted

Mean

Standard Error

h*mcg/dL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300)

Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*mcg/dL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300)

Posted

Mean

Standard Error

h*mcg/dL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700)

Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*mcg/dL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700)

Posted

Mean

Standard Error

h*mcg/dL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of ACTH at 0700

Participants Mean Level of ACTH at 0700.

Posted

Mean

Standard Error

pg/mL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of ACTH at 0700

Participants Mean Level of ACTH at 0700.

Posted

Mean

Standard Error

pg/mL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours

Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*pg/mL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours

Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*pg/mL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500)

Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*pg/mL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500)

Posted

Mean

Standard Error

h*pg/mL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300)

Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*pg/mL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300)

Posted

Mean

Standard Error

h*pg/mL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700)

Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*pg/mL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700)

Posted

Mean

Standard Error

h*pg/mL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaenous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Progesterone Levels at 0700

Participants Mean Level of Progesterone at 0700

Posted

Mean

Standard Error

ng/mL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Progesterone Level at 0700

Participants Mean Level of Progesterone at 0700

Posted

Mean

Standard Error

ng/mL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours

Participants Mean Level of Progesterone area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*ng/dL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours

Posted

Mean

Standard Error

h*ng/dL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500)

Participants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*ng/dL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500)

Posted

Mean

Standard Error

h*ng/dL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300)

Participants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*ng/dL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300)

Posted

Mean

Standard Error

h*ng/dL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700)

Participants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).

Posted

Mean

Standard Error

h*ng/dL

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700)

Posted

Mean

Standard Error

h*ng/dL

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participant Lean Body Mass

lean body mass measured by DEXA, Hologic Discovery-A

Posted

Mean

Standard Error

At baseline

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Secondary

Participant Lean Body Mass

lean body mass measured by DEXA, Hologic Discovery-A

Posted

Mean

Standard Error

At 6 months

ID	Title	Description
OG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Continuous Subcutaneous Hydrocortisone Infusion	Enrolled participants with congenital adrenal hyperplasia (CAH) will receive continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722Na) to deliver near-physiologic cortisol replacement therapy Hydrocortisone (Solucortef): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA) Insulin pump (Medtronic): Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)	0	8	0	8	8	8

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Skin erythema with pruritis at the infusion set site	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 affected8 at risk
Local skin infection at the infusion set site	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0005 affected8 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0005 affected8 at risk
Lightheadedness	Nervous system disorders	Systematic Assessment	EG0005 affected8 at risk
Weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 affected8 at risk
Fatigue	General disorders	Systematic Assessment	EG0007 affected8 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0002 affected8 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0007 affected8 at risk
Carpal tunnel	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected8 at risk
Knee pain when walking	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected8 at risk
Tinnutus	Ear and labyrinth disorders	Systematic Assessment	EG0001 affected8 at risk
Decreased appetite	Gastrointestinal disorders	Systematic Assessment	EG0002 affected8 at risk
Increased appetite	Gastrointestinal disorders	Systematic Assessment	EG0006 affected8 at risk
Difficulty falling asleep or frequent wakening	General disorders	Systematic Assessment	EG0005 affected8 at risk
Early morning wakening	General disorders	Systematic Assessment	EG0003 affected8 at risk
Increased acne	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected8 at risk
Weight gain	General disorders	Systematic Assessment	EG0005 affected8 at risk

Ancestor Terms

ID	Term
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases
D058489	46, XX Disorders of Sex Development
D012734	Disorders of Sex Development
D014564	Urogenital Abnormalities
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D047808	Adrenogenital Syndrome
D052801	Male Urogenital Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006058	Gonadal Disorders
D030342	Genetic Diseases, Inborn
D043202	Steroid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D000309	Adrenal Insufficiency
D017588	Hyperandrogenism
D000312	Adrenal Hyperplasia, Congenital

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D015062	11-Hydroxycorticosteroids
D006889	Hydroxycorticosteroids
D000305	Adrenal Cortex Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D015065	17-Hydroxycorticosteroids