Reducing the Risk of Metabolic Decompensation in Adolescents With Poorly Controlled Type 1 Diabetes by Supervised School Administration of Insulin Degludec
Overview
- Phase
- Early Phase 1
- Intervention
- Insulin Degludec
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- Yale University
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Lower beta hydroxybutyrate levels
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of T1D, diagnosed at least 12 months prior to enrollment
- •HbA1c ≥8.5%9 and \<14% on enrollment
- •Taking no medications known to affect blood glucose levels other than insulin.
- •Ability to provide participant written informed consent if age 18 years, or parental written informed consent and participant assent if participant is \< age 18 before any trial-related activities
- •Current regimen includes insulin detemir or I-glar, as long acting insulin
- •Willingness to use either I-glar or I-deg pens as basal insulin, and have school personnel supervise administration
- •Willingness to have school personnel supervise fasting blood β-hydroxybutyrate levels first thing in the morning at the beginning and end of each school week
- •Willingness to have school personnel supervise fasting blood glucose checks daily in the morning on school days, and eat breakfast after the fasting check
Exclusion Criteria
- •Female participants who are pregnant, breast-feeding or planning on becoming pregnant
- •Participant (and parent if age \<18) unable to read, write, and speak English.
- •Adolescents who are home schooled or no longer attending secondary school
- •Participant's school is unable to provide personnel to supervise injections of long-acting insulin or measurement blood glucose and β-hydroxybutyrate levels
- •Known or suspected allergy to trial medication(s), excipients, or related products.
- •Contraindications to study medications, including hypersensitivity to I-deg or one of its excipients, hypersensitivity to I-glar or one of its excipients, and administration of either during episodes of hypoglycaemia
Arms & Interventions
subjects receiving insulin degludec
Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin degludec injections.
Intervention: Insulin Degludec
Subjects receiving insulin glargine
Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin glargine injections.
Intervention: Insulin Glargine
Outcomes
Primary Outcomes
Lower beta hydroxybutyrate levels
Time Frame: 4 months
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.
Secondary Outcomes
- Control of HbA1c levels(4 months)
- Measure of beta hydroxybutyrate levels between the 2 groups.(4 months)