A Study of Continuous Subcutaneous Insulin Infusion (CSII... | NCT03662334

NCT03662334

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

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
Hylenex recombinant	Experimental	Comparing the preadministration of Hylenex recombinant in the setting of continuous subcutaneous insulin infusion (CSII).	Drug: Rapid Acting insulin with pre-treatment of rHuPH20
Sham Injection	Sham Comparator	Comparing the preadministration of a sham injection in the setting of CSII.	Device: Sham injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rapid Acting insulin with pre-treatment of rHuPH20	Drug	Hylenex recombinant will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1: Area Under the Curve (AUC) of Glucose Infusion Rate (GIR) From 0-6 Hours		0-6 hours
Part 2: Time to Reduction in Plasma Glucose by 80 Milligrams Per Deciliter (mg/dL) Following CSII Bolus	Time to reduction is reported as the maximum time it took for any participant receiving each treatment sequence to achieve a reduction in plasma glucose by 80 mg/dL. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.	0-10 hours
Part 3: Time to Achieve Plasma Glucose >90 mg/dL After Release of Hypoglycemic CSII Clamp		0-12 hours

Secondary Outcomes

Measure	Description	Time Frame
Part 1: Time-action Profile, Assessed by GIR in Euglycemic Participants		up to approximately 10 hours
Part 1: Mean Maximum Concentration (Cmax)		up to approximately 22 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female participants between the ages 18 and 65 years, inclusive.
Females of child-bearing potential must agree to use a standard and effective means of birth control for the duration of the study. Adequate contraceptive measures include oral or injectable contraceptives, sterilization, intra-uterine device (IUD), barrier methods, or abstinence.
Participants with type 1 diabetes mellitus treated with insulin (multiple daily injections or continuous subcutaneous insulin infusion [CSII]) diagnosed ≥ 12 months prior to enrollment
Body mass index (BMI) 18.0 to 32.0 kilograms per meters squared (kg/m^2)
HbA1c (glycated hemoglobin A1c) ≤ 10% based on local laboratory results
Fasting C-peptide < 0.6 nanograms per milliliter (ng/mL)
Current treatment with insulin <1.2 Units per kg per day (U/kg/day)
Participant should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug injections and assessments required in this protocol

Exclusion Criteria:

Inability to comply with study requirements as judged by the Investigator
Known or suspected allergy to any component of any of the study drugs in this trial
A participant who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on electrocardiogram), hepatic, neurological, renal, genitourinary, or hematological systems
As judged by the Investigator, uncontrolled hypertension (diastolic blood pressure ≥ 100 millimeters of mercury [mmHg] and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the supine position)
History of any illness or disease that in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the study drugs to the participant
As judged by the Investigator, clinically significant findings in routine laboratory data. Anemia with hemoglobin less than lower limits of normal at screening is specifically exclusionary
Use of drugs that may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia, or drugs not permitted according to Hylenex recombinant package insert
Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator
Current addiction to alcohol or substances of abuse as determined by the Investigator
Blood donation (> 500 mL) within the previous 8 weeks (56 days) prior to Day -1 of Treatment Period 1
Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, IUD, oral or injectable contraceptives, or barrier methods)
Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study
Participation in any other clinical trial and receipt of any investigational drug within 4 weeks of Day -1 of Treatment Period 1
Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with trial participation or evaluation of data
Positive for human immunodeficiency virus (HIV), Hepatitis C or Hepatitis B
Tobacco and nicotine use within 3 months prior to Day 1 of Treatment Period 1 or use during the study

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Profil Institute for Clinical Research		Chula Vista	California	91911	United States

References Module

Label	URL
Halozyme Therapeutics	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG0000 subjects
FG0010 subjects

Baseline data were collected in members of the Safety Population, comprised of all randomized participants exposed to at least one dose of study drug.

Arm/Group Information

ID	Title	Description
BG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
BG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0007 BG0017 BG00214

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

White or Caucasian

Title	Measurements
	BG0007 BG0017 BG002

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

Part 1: Area Under the Curve (AUC) of Glucose Infusion Rate (GIR) From 0-6 Hours

The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.

Posted

0-6 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Units	Counts
Participants	OG0000 OG0010

Primary

Part 2: Time to Reduction in Plasma Glucose by 80 Milligrams Per Deciliter (mg/dL) Following CSII Bolus

Time to reduction is reported as the maximum time it took for any participant receiving each treatment sequence to achieve a reduction in plasma glucose by 80 mg/dL. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.

Safety Population: all randomized participants exposed to at least one dose of study drug

Posted

Number

hours

0-10 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Primary

Part 3: Time to Achieve Plasma Glucose >90 mg/dL After Release of Hypoglycemic CSII Clamp

The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.

Posted

0-12 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Units	Counts
Participants	OG000

Secondary

Part 1: Time-action Profile, Assessed by GIR in Euglycemic Participants

The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.

Posted

up to approximately 10 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Units	Counts
Participants	OG000

Secondary

Part 1: Mean Maximum Concentration (Cmax)

The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.

Posted

up to approximately 22 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Units	Counts
Participants	OG000

Secondary

Part 1: Time to Achieve Maximum Concentration (Tmax)

The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.

Posted

up to approximately 22 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Units	Counts
Participants	OG000

Secondary

Part 1: Early Time to 50% Maximum Serum Insulin Concentration (t50%) Max

The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.

Posted

up to approximately 22 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Units	Counts
Participants	OG000

Secondary

Part 1: Time to 50% of Total AUC (AUC0-last)

The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.

Posted

up to approximately 22 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Units	Counts
Participants	OG000

Secondary

Part 1: Fractional and Absolute AUC0-1hr

The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.

Posted

0 to 1 hour

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Units	Counts
Participants	OG000

Secondary

Part 1: Fractional and Absolute AUC2hr-end

The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.

Posted

2 to approximately 22 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Units	Counts
Participants	OG000

Secondary

Part 1: Area Under the Curve From Time Zero to the Last Measureable Concentration (AUC0-last)

The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.

Posted

up to approximately 22 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Units	Counts
Participants	OG000

Secondary

Part 1: Mean Residence Time (MRT)

The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.

Posted

up to approximately 22 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Units	Counts
Participants	OG000

Secondary

Part 2: Plasma Glucose Concentration Over Time

Plasma glucose concentration over time is reported as the maximum concentration for any participant receiving each treatment sequence. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.

Safety Population

Posted

Number

mg/dL

up to approximately 10 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Secondary

Part 2: Insulin Analog Serum Concentration as a Function of Time Following Bolus Insulin Infusion

Insulin analog serum concentration is reported as the maximum concentration for any participant receiving each treatment sequence. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.

Safety Population

Posted

Number

picomolar

up to approximately 10 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Secondary

Part 3: Plasma Glucose Concentration Over Time

The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.

Posted

up to approximately 12 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

Units	Counts
Participants	OG000

Secondary

Part 3: Insulin Analog Serum Concentration as a Function of Time Following Termination of Insulin Infusion

The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.

Posted

up to approximately 12 hours

ID	Title	Description
OG000	Hyaluronidase Human Injection/Sham Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
OG001	Sham Injection/Hyaluronidase Human Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.

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	Hyaluronidase Human Injection	Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of either Treatment Period 1 or Treatment Period 2. The two periods were separated by a 3- to 7-day washout period.	0	14	0	14	4	14
EG001	Sham Injection	Participants received pretreatment of 1 mL sham injection on Day 1 of either Treatment Period 1 or Treatment Period 2. The two periods were separated by a 3- to 7-day washout period.	0	14	0	14	2	14

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection Site Pain	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected14 at risk EG0010 affected14 at risk
Injection Site Haematoma	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected14 at risk
Pyrexia	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected14 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected14 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected14 at risk EG0011 affected14 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected14 at risk EG0010 affected14 at risk

During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 milligrams per deciliter. The study was stopped early, prior to enrolling the planned 24 participants for Part 2.

Certain Agreements

ID	Term
D003922	Diabetes Mellitus, Type 1
D003920	Diabetes Mellitus
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D006946	Hyperinsulinism

ID	Term
D061266	Insulin, Short-Acting
D061268	Insulin Lispro

Ancestor Terms

ID	Term
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Units	Counts
Participants	OG0007 OG0017