| Trial ID: | L2785 |
| Source ID: | NCT03400501
|
| Associated Drug: |
Insulin Degludec
|
| Title: |
Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin Degludec|DRUG: Insulin Glargine
|
| Outcome Measures: |
Primary: Lower beta hydroxybutyrate levels, Will test the the hypothesis that β-hydroxybutyrate levels will be lower in the morning (≥0.6 mmol/L) of the first day of the school week in subjects receiving I-deg, since the long half-life of I-deg will compensate for missed insulin doses over the weekend/holidays., 4 months | Secondary: Control of HbA1c levels, Test the hypothesis that the longer duration of action of I-deg will lead to improvements in glycemic control measured by HbA1c (a secondary aim) and fasting glucose., 4 months|Measure of beta hydroxybutyrate levels between the 2 groups., Test the differences in frequency of elevated β-hydroxybutyrate levels when receiving supervised injections of basal insulin versus when not receiving supervised injections between the I-deg and I-glar groups, 4 months
|
| Sponsor/Collaborators: |
Sponsor: Yale University
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2017-10-01
|
| Completion Date: |
2021-06-07
|
| Results First Posted: |
|
| Last Update Posted: |
2021-11-05
|
| Locations: |
Yale University, New Haven, Connecticut, 06511, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03400501
|
