Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin

Early Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: Insulin Degludec; Drug: Insulin Glargine

• Registration Number: NCT03400501
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Primary Completion: 2021-06-07
• Study Completion: 2021-06-07
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-04
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
subjects receiving insulin degludec	Insulin Degludec	Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin degludec injections.
Subjects receiving insulin glargine	Insulin Glargine	Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin glargine injections.

Primary Outcome Measures

Name	Time	Method
Lower beta hydroxybutyrate levels	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 Outcome Measures

Name	Time	Method
Control of HbA1c levels	4 months	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.
Measure of beta hydroxybutyrate levels between the 2 groups.	4 months	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

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States