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

PHASE4CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

March 15, 2023

Primary Completion Date

August 13, 2024

Study Completion Date

March 19, 2025

Conditions
Diabetes Mellitus, Type 1Type 1 Diabetes
Interventions
DRUG

Insulin Glargine

"Formulation: Available as a clear liquid in a glass cartridge (1 cartridge =3ml=300 units).~Route: Reusable pen~Amount of each dose: varies depending on baseline basal insulin needs~Dose escalation scheme: Participants randomly assigned to glargine will start with a dose that is generally equal to 80% of their total basal human insulin dose prior to the switch (per ISPAD guidelines and the switching guide developed by Life for a Child with the guidance of Dr. Ragnar Hanas and two other ISPAD members familiar with less-resourced settings).~Frequency of dose: once per day (usually administered before bedtime)~Duration of therapy: 12 months"

DRUG

NPH or premixed 70/30 (human insulin)

"Formulation: Available as a liquid in a glass cartridge (3ml=300IU) or as liquid in a prefilled, disposable pen (3ml=300IU).~Route: Bangladesh = reusable pens; Tanzania = disposable pens~Amount of each dose: varies depending on baseline basal insulin needs (per usual care or treating clinician)~Frequency of dose: once or twice per day (per usual care or treating clinician)~Duration of therapy: 12 months"

Trial Locations (3)

Unknown

BIRDEM Hospital, Dhaka

Bugando Medical Center, Mwanza

Sekou-Toure Hospital, Mwanza

All Listed Sponsors
collaborator

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

lead

Jing Luo

OTHER