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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Single daily dose of insulin degludec based on their fasting blood glucose levels and current long acting insulin dose
Single daily dose of insulin glargine based on their fasting blood glucose levels and current long acting insulin dose
Yale University
New Haven, Connecticut, United States
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
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