Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings

• Status: Not yet recruiting
• Trial end date: 2024-11-30
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this trial is to determine whether insulin glargine reduces the risk of serious hypoglycemia or improves Time in Range at 6 months when compared against standard of care human insulin (e.g. NPH or premixed 70/30) among youth living with type 1 diabetes (T1D) in low resource settings.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jing Luo
• Collaborator: The Leona M. and Harry B. Helmsley Charitable Trust
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. Children and young adults (age 7-25)

2. Have a clinical diagnosis of type 1 diabetes (T1D)

Exclusion Criteria:

1. Prior use of any insulin analogue

2. Patients (or parents for children <18 years old) who refuse to or cannot provide informed consent

3. Who are currently pregnant or plan to become pregnant over the next year

4. Who have previously used a continuous glucose monitor (CGM) for glucose monitoring

5. Who were first diagnosed with T1D less than 12 months ago

6. Who is diagnosed with severe malnutrition