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

NCT ID: NCT03400501

Last Updated: 2021-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2021-06-07

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

subjects receiving insulin degludec

Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin degludec injections.

Group Type: EXPERIMENTAL

Insulin Degludec

Intervention Type: DRUG

Single daily dose of insulin degludec based on their fasting blood glucose levels and current long acting insulin dose

Subjects receiving insulin glargine

Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin glargine injections.

Group Type: ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type: DRUG

Single daily dose of insulin glargine based on their fasting blood glucose levels and current long acting insulin dose

Interventions

Insulin Degludec

Single daily dose of insulin degludec based on their fasting blood glucose levels and current long acting insulin dose

Intervention Type: DRUG

Insulin Glargine

Single daily dose of insulin glargine based on their fasting blood glucose levels and current long acting insulin dose

Intervention Type: DRUG

Other Intervention Names

I-degludec; I-glar

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Tamborlane, PhD

Role: PRINCIPAL_INVESTIGATOR

MED School of Medicine

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000020909

Identifier Type: -

Identifier Source: org_study_id