Trial Outcomes & Findings for Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D) (NCT NCT00357890)

Results Overview

Insulin sensitivity - glucose infusion rate (GIR) obtained from hyperinsulinemic-euglycemic clamp. Higher GIR reflects higher insulin sensitivity, lower GIR reflects lower insulin sensitivity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

24 months

Results posted on

2023-07-07

Participant Flow

Participant milestones

Participant milestones
Measure	Pump Therapy (CSII) Use of pump therapy Insulin pump therapy: CSII initiated within 1 month of diagnosis	Multiple Daily Injections (MDI) Use of MDI (basal bolus therapy with glargine) Multiple daily injections using insulin glargine + rapid acting analog: MDI as control
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pump Therapy (CSII) n=6 Participants Use of pump therapy Insulin pump therapy: CSII initiated within 1 month of diagnosis	Multiple Daily Injections (MDI) n=6 Participants Use of MDI (basal bolus therapy with glargine) Multiple daily injections using insulin glargine + rapid acting analog: MDI as control	Total n=12 Participants Total of all reporting groups
Age, Continuous	14.1 years STANDARD_DEVIATION 1.1 • n=5 Participants	13.7 years STANDARD_DEVIATION 1.4 • n=7 Participants	13.9 years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: 12 adolescents were randomized, 6 per treatment group, well matched at baseline.

Insulin sensitivity - glucose infusion rate (GIR) obtained from hyperinsulinemic-euglycemic clamp. Higher GIR reflects higher insulin sensitivity, lower GIR reflects lower insulin sensitivity.

Outcome measures

Outcome measures
Measure	Pump Therapy (CSII) n=6 Participants Insulin pump therapy group	Multiple Daily Injections (MDI) n=6 Participants Control group - patients placed on multiple daily injections
Insulin Sensitivity Baseline	8.6 mg/kg/min Standard Error 1.6	6.2 mg/kg/min Standard Error 1.3
Insulin Sensitivity 24 month	5.8 mg/kg/min Standard Error 1.0	4.8 mg/kg/min Standard Error 0.9

PRIMARY outcome

Timeframe: 24 months

Population: 12 adolescents were randomized, 6 per treatment group, well matched at baseline.

Beta cell function as assessed by peak c-peptide using mixed meal tolerance testing

Outcome measures

Outcome measures
Measure	Pump Therapy (CSII) n=6 Participants Insulin pump therapy group	Multiple Daily Injections (MDI) n=6 Participants Control group - patients placed on multiple daily injections
Beta Cell Function Baseline	2.1 ng/mL Standard Error 0.4	1.7 ng/mL Standard Error 0.3
Beta Cell Function 24 months	1.1 ng/mL Standard Error 0.4	1.6 ng/mL Standard Error 0.9

SECONDARY outcome

Timeframe: 24 months

Population: 12 adolescents were randomized, 6 per treatment group, well matched at baseline.

Hemoglobin A1c (HbA1c) (%)

Outcome measures

Outcome measures
Measure	Pump Therapy (CSII) n=6 Participants Insulin pump therapy group	Multiple Daily Injections (MDI) n=6 Participants Control group - patients placed on multiple daily injections
Hemoglobin A1c 24 months	6.8 percentage of glycosylated hemoglobin Standard Error 0.4	7.5 percentage of glycosylated hemoglobin Standard Error 0.5
Hemoglobin A1c Baseline	10 percentage of glycosylated hemoglobin Standard Error 0.4	10.2 percentage of glycosylated hemoglobin Standard Error 0.3
Hemoglobin A1c 12 months	6.1 percentage of glycosylated hemoglobin Standard Error 0.3	7.0 percentage of glycosylated hemoglobin Standard Error 0.6

SECONDARY outcome

Timeframe: 24 months

Population: 12 adolescents were randomized, 6 per treatment group, well matched at baseline.

Percent body fat based on DEXA scan (%BF)

Outcome measures

Outcome measures
Measure	Pump Therapy (CSII) n=6 Participants Insulin pump therapy group	Multiple Daily Injections (MDI) n=6 Participants Control group - patients placed on multiple daily injections
Percent Body Fat Baseline	20 percentage of body fat Standard Error 2.6	21.6 percentage of body fat Standard Error 4.0
Percent Body Fat 12 months	18.5 percentage of body fat Standard Error 3.6	20.3 percentage of body fat Standard Error 3.8
Percent Body Fat 24 months	17.4 percentage of body fat Standard Error 2.5	20.5 percentage of body fat Standard Error 2.3

Adverse Events

Pump Therapy (CSII)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Multiple Daily Injections (MDI)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Larry A Fox, MD

Nemours Children's Health

Phone: 9046973600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place