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

• Status: Completed
• Trial end date: 2021-06-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Insulin, Long-Acting

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