An Early Phase 1 interventional study of Insulin Degludec and Insulin Glargine in Type 1 Diabetes Mellitus, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-11-05.
Sponsored by Yale University · Early Phase 1, Interventional, and Treatment
This is a pilot study to examine and compare the efficacy of supervised injections of long acting insulins degludec and glargine to protect youth with poorly controlled type 1 diabetes (T1D) from development of ketones.
This study will compare the proportion of days with fasting β-hydroxybutyrate levels ≥0.6 mmol/L at the start of the school week following weekend/holiday breaks in subjects who have been randomized to receive daily injections of I-deg or I-glar. Hypothesis: β-hydroxybutyrate levels will be lower in the morning of the first day of the school week in subjects receiving I-deg than in subjects receiving I-glar, since the long half-life of I-deg will compensate for missed insulin doses over the weekend/holidays. To remove variability due to potential non-compliance during the school week, this study will utilize our routine clinical practice of supervised insulin administration and monitoring of blood glucose and ketones during the school day.
Exclusion Criteria:
Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin degludec injections.
Drug: Insulin Degludec
Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin glargine injections.
Drug: Insulin Glargine
Single daily dose of insulin degludec based on their fasting blood glucose levels and current long acting insulin dose
Also known as: I-degludec
Single daily dose of insulin glargine based on their fasting blood glucose levels and current long acting insulin dose
Also known as: I-glar
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.
Time frame: 4 months
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.
Time frame: 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
Time frame: 4 months
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Yale University