MedTrace Logo

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

NCT03400501 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-11-05

No results posted yet for this study

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

Interventions

DRUG

Insulin Degludec

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

DRUG

Insulin Glargine

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

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • William Tamborlane, PhD · MED School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2021-06-07
Completion
2021-06-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03400501 on ClinicalTrials.gov