Effect of Metabolic Control at Onset of Diabetes on Progr... | NCT00891995

NCT00891995

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
Intensive Treatment	Experimental	closed loop therapy (4-6 days), insulin pump (2 years), continuous glucose monitoring (2 years), home glucose monitoring (2 years)	Device: Closed loop Device: Home glucose monitoring Device: Insulin pump Device: Continuous glucose monitor
Standard Treatment	Active Comparator	home glucose monitoring (2 years)	Device: Home glucose monitoring

Name	Type	Description	Arm Group Labels	Other Names
Closed loop	Device	Closed loop therapy for up to 4 to 6 days	Intensive Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.	In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49).	At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal

Secondary Outcomes

Measure	Description	Time Frame
Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment		0 to 240 min post meal at 1 year MMTT
Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT	Outcome measure in the table is the incidence of 2 hour peak C-peptide>=0.2 pmol/ml. Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Roy W Beck, M.D., Ph.D.	Jaeb Center for Health Research	Study Director
Jay S. Skyler, M.D., M.A.C.P.	University of Miami	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Stanford	California	94305	United States
Barbara Davis Center for Childhood Diabetes

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24130350	Background	Buckingham B, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Tamborlane WV; Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group. Effectiveness of early intensive therapy on beta-cell preservation in type 1 diabetes. Diabetes Care. 2013 Dec;36(12):4030-5. doi: 10.2337/dc13-1074. Epub 2013 Oct 15.
23570538

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	Intensive Treatment	The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and continuous glucose monitoring (CGM) in addition to standard monitoring with a home glucose meter for 2 years.
FG001	Standard Treatment

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

Only 48 participants in the intensive treatment group and 20 participants in the standard treatment group who show any positive autoantibody in the first year were included in the analyses.

Arm/Group Information

ID	Title	Description
BG000	Intensive Treatment	The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
BG001	Standard Treatment	The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00048 BG00120 BG00268

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	BG00046 BG00119 BG00265
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00012.7± 4.7 BG00114.7± 7.6 BG002

Gender

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00017 BG0017 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG00042 BG00118 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

C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.

In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49).

Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.

Posted

Geometric Mean

95% Confidence Interval

pmol/ml

At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal

ID	Title	Description
OG000	Intensive Treatment	The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
OG001	Standard Treatment	The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.

Units	Counts
Participants	OG00047 OG00120

Title

Denominators

Categories

Title	Measurements
	OG0000.43(0.34 to 0.52) OG0010.52(0.32 to 0.75)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Adjusted for baseline C-peptide AUC, age, gender and diabetic ketoacidosis.	0.49	One-sided p-value.												No	Superiority or Other

Secondary

Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment

Posted

Geometric Mean

95% Confidence Interval

pmol/ml

0 to 240 min post meal at 1 year MMTT

ID	Title	Description
OG000	Intensive Treatment	The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
OG001	Standard Treatment	The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.

Units	Counts
Participants	OG000

Secondary

Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT

Outcome measure in the table is the incidence of 2 hour peak C-peptide>=0.2 pmol/ml. Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported.

Posted

Number

participants

0 to 240 min post meal at 1 year MMTT

ID	Title	Description
OG000	Intensive Treatment	The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
OG001	Standard Treatment	The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.

Units	Counts
Participants

Secondary

HbA1c

Posted

Mean

Standard Deviation

percent

1 year

ID	Title	Description
OG000	Intensive Treatment	The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
OG001	Standard Treatment	The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.

Units	Counts
Participants	OG000

Secondary

Adverse Events (Severe Hypoglycemia)

Posted

Number

participants

1 year

ID	Title	Description
OG000	Intensive Treatment	The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
OG001	Standard Treatment	The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.

Units	Counts
Participants	OG000

Secondary

CGM Mean Glucose

Participants who used CGM (either blinded or unblinded CGM) for at least 24 hours at 12 months.

Posted

Median

Inter-Quartile Range

mg/dL

1 year

ID	Title	Description
OG000	Intensive Treatment	The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
OG001	Standard Treatment	The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.

Units	Counts
Participants	OG000

Secondary

CGM Measured Glucose Outcomes

Include a series of glucose indices created from CGM measured glucose data, such as % time with glucose values <=70 mg/dl, % time with glucose values within target range of 71-180 mg/dl, % time with glucose values >180 mg/dl, and glucose variability as measured by coefficient of variation. These indices were calculated by giving equal weight to each of the 24 h of the day. At least 24 h of CGM data were required for calculating these indices.

Participants who used CGM (either blinded or unblinded CGM) for at least 24 hours at 12 months.

Posted

Median

Inter-Quartile Range

percent

1 year

ID	Title	Description
OG000	Intensive Treatment	The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
OG001	Standard Treatment	The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.

Units	Counts
Participants

Secondary

Daily Insulin Dose

Posted

Mean

Standard Deviation

u/day/kg

1 year

ID	Title	Description
OG000	Intensive Treatment	The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
OG001	Standard Treatment	The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.

Units	Counts
Participants	OG000

Secondary

BMI Percentile

Posted

Median

Inter-Quartile Range

percent

1 year

ID	Title	Description
OG000	Intensive Treatment	The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
OG001	Standard Treatment	The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.

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	Intensive Treatment	The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.			2	48	6	48
EG001	Standard Treatment	The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.			1	20	2	20

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
gastroenteritis	Gastrointestinal disorders	Non-systematic Assessment	In the usual care group, one participant was hospitalized for gastroenteritis.	EG0000 events0 affected48 at risk EG0011 events1 affected20 at risk
Anaphylactic reaction	General disorders	Non-systematic Assessment	During inpatient hybrid closed-loop control (HCLC) therapy, one subject had an anaphylactic reaction following his first dinner, presumably resulting from a peanut allergy, and received intravenous steroids.	EG0001 events1 affected48 at risk EG0010 events0 affected20 at risk
Suicidal ideation	Psychiatric disorders	Non-systematic Assessment	During follow up, in the intensive group, one participant with a prior history of depression developed suicidal ideation.	EG0001 events1 affected48 at risk EG0010 events0 affected20 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
severe hypoglycemia	Endocrine disorders	Non-systematic Assessment	Severe hypoglycemia occurred in one participant (two events, at 6 months while CGM was being used and 12 months after CGM had been discontinued) in the intensive group and in no participants in the usual care group.	EG0002 events1 affected48 at risk EG0010 events0 affected20 at risk
venous thrombosis	Vascular disorders	Non-systematic Assessment	There were two cases of venous thrombosis related to the intravenous line that resolved without consequence.	EG0002 events2 affected48 at risk EG0010 events0 affected20 at risk
faint	General disorders	Non-systematic Assessment	During follow up, in the intensive group, one participant fainted following the 3-month MMTT	EG0001 events1 affected48 at risk EG0010 events0 affected20 at risk
skin infection	Skin and subcutaneous tissue disorders	Non-systematic Assessment	During follow up, in the intensive group, one participant had a skin infection related to the CGM sensor insertion.	EG0001 events1 affected48 at risk EG0010 events0 affected20 at risk
depression and anxiety	Psychiatric disorders	Non-systematic Assessment	In the usual care group, two participants developed depression and anxiety.	EG0000 events0 affected48 at risk EG0012 events2 affected20 at risk
Needle stick/puncture	Skin and subcutaneous tissue disorders	Non-systematic Assessment	On admission, during insertion of sensor into abdomen of patient, the skin was pinched up due to minimal body fat. The sensor entered subject's skin then exited other side and punctured nurse's thumb which resulted in cross contamination.	EG0001 events1 affected48 at risk EG0010 events0 affected20 at risk

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D015190	Blood Glucose Self-Monitoring
D007332	Insulin Infusion Systems

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D003940	Diagnostic Techniques, Endocrine
D008991	Monitoring, Physiologic
D000085263	Self-Testing
D012648	Self Care
D013812	Therapeutics
D008919	Investigative Techniques
D016503	Drug Delivery Systems
D004358	Drug Therapy
D007260	Infusion Pumps
D004864	Equipment and Supplies
D001187	Artificial Organs
D013523	Surgical Equipment

BG0002
BG0011
BG0023