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Introducing Biosimilar Insulin Glargine to the Treatment Regimen of Children and Youth with Type 1 Diabetes in Mali

NCT06624943 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2024-10-03

No results posted yet for this study

Summary

This study aimed to evaluate the impact on blood glucose control and quality of life in children and youth with type 1 diabetes in Mali by switching the insulin regimen from human insulin via needle and syringe, to long-acting biosimilar insulin glargine delivered by reusable pens combined with short-acting insulin via needle and syringe.

Conditions

  • Type 1 Diabetes (T1D)

Interventions

DRUG

biosimilar insulin glargine

Once daily injection of biosimilar insulin glargine via reusable pen

Sponsors & Collaborators

  • Sante Diabete Mali

    collaborator OTHER

  • Hospital of Mali

    collaborator UNKNOWN

  • Centre Hospitalier du Luxembourg

    collaborator OTHER

  • University Hospital, Geneva

    collaborator OTHER

  • Life for a Child Program, Diabetes Australia

    lead OTHER

Principal Investigators

  • Stéphane Besançon, MSC · ONG Santé Diabète,Bamako,Mali & Unité PACRI,Conservatoire National des Arts et Métiers,Paris,France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2023-05-05
Completion
2023-05-05
FDA Drug
Yes

Countries

  • Mali

Study Locations

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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 NCT06624943 on ClinicalTrials.gov