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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Reducing the Risk of Metabolic Decompensation in Adolescents With Poorly Controlled Type 1 Diabetes by Supervised School Administration of Insulin Degludec

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400501
• Other study ID #: 2000020909
• Status: Completed
• Phase: Early Phase 1
• Start date: October 1, 2017
• Est. completion date: June 7, 2021

Study information

• Verified date: November 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 7, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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 ß-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 ß-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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Insulin Degludec
Single daily dose of insulin degludec based on their fasting blood glucose levels and current long acting insulin dose
• Insulin Glargine
Single daily dose of insulin glargine based on their fasting blood glucose levels and current long acting insulin dose

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower beta hydroxybutyrate levels	Will test the the hypothesis that ß-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
Secondary	Measure of beta hydroxybutyrate levels between the 2 groups.	Test the differences in frequency of elevated ß-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