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

NCT03400501 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 2000020909
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Lower beta hydroxybutyrate levels

  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.

  4 months

Secondary Outcomes (2)

• Control of HbA1c levels

  4 months

• Measure of beta hydroxybutyrate levels between the 2 groups.

  4 months

Study Arms (2)

subjects receiving insulin degludec

EXPERIMENTAL

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

Drug: Insulin Degludec

Subjects receiving insulin glargine

ACTIVE COMPARATOR

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

Drug: Insulin Glargine

Interventions

Insulin Degludec DRUG

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

Also known as: I-degludec

subjects receiving insulin degludec

Insulin Glargine DRUG

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

Also known as: I-glar

Subjects receiving insulin glargine

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin degludec; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• William Tamborlane, PhD

  MED School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: October 1, 2017
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: November 5, 2021

Record last verified: 2021-11

Locations

US (1)