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

Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Mali

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes (T1D)
• Intervention / Treatment: Drug: biosimilar insulin glargine

Detailed Description

Analog insulins are widely used in middle- and high-income countries. However, use of analog insulin remains limited in lower-income countries due to their increased cost and lack of access, and human insulin remains the mainstay of treatment in these settings.

Long-acting (basal) analog insulin such as glargine have the benefit of a longer duration (up to 24 hours) and a minimal peak action, and generally, only one injection per day is required. Although glargine insulin has been shown to reduce the risk of overnight hypoglycemia, consistent improvement in blood glucose control (measured by HbA1c) when compared to human insulin has not been shown, and its impact on quality of life is also inconclusive. Furthermore, these studies have all been done in highly resourced countries.

Life for a Child (LFAC) has been providing diabetes supplies (insulin, syringes, meters and strips for blood glucose self-monitoring), diabetes-related education, mentoring and technical support to Santé Diabète in Mali since 2008. In 2021, LFAC commenced supplying Basaglar (glargine) insulin with insulin pen devices (HumaPen Ergo ll). This provided a unique opportunity to investigate the effect of introducing glargine (Basaglar) insulin in the low-resource setting of Mali, one of the world's poorest countries.

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mali
  • Bamako, Mali
    • Hôpital du Mali

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

(i) diagnosed with T1D in accordance with World Health Organization criteria

(ii) duration of T1D ≥12 months at time of enrolment

(iii) aged <25 years at time of enrolment

(iv) current insulin regimen consisting of Humulin NPH® and R, or pre-mixed insulin (30/70 R/NPH), with no prior use of analogue insulin

(vi) willing to regularly self-monitor blood glucose (SMBG) levels ≥2 times a day with a blood glucose meter and strips

(vii) live in or within one hour's travelling distance of Bamako

Exclusion Criteria:

(i) Previous use of analog insulin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Continue current treatment with either intermediate- and short-acting human insulin, or pre-mixed insulin, both via needle and syringe
Experimental: Intervention; Switched to once daily injection of biosimilar insulin glargine via reusable pen and three mealtime bolus insulin injections of short-acting human insulin via needle and syringe	Drug: biosimilar insulin glargine; Once daily injection of biosimilar insulin glargine via reusable pen; Other Names: Basaglar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c was measured at each study time point using point of care testing via a Siemens DCA calibrated to international standards (DCA Vantage™ Analyzer (Siemens Healthcare Diagnostics, Tarrytown NY, US)). For HbA1c readings >14% (>130 mmol/mol), the maximum reading of this analyser, HbA1c was recorded as 14% (130 mmol/mol).	Baseline, 3-, 6-, 9- and 12-month follow-up visits

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodes of diabetic ketoacidosis	Diabetic ketoacidosis was defined as hyperglycaemia (BGL>11mmol/L/200mg/dL) with a venous pH<7·3 or serum bicarbonate <15mmol/L and ketonuria and/or ketonaemia	Baseline, 3-, 6-, 9- and 12-month follow-up visits
Episodes of severe hypoglycaemia	Severe hypoglcaemia was defined as an event with severe cognitive impairment (with or without coma and convulsions) requiring assistance by another person to administer carbohydrates, glucagon, or intravenous dextrose to restore glycaemia	Baseline, 3-, 6-, 9- and 12-month follow-up visits
Diabetes Quality of Life in Youth - Short Form	The 21-item Diabetes Quality of Life in Youth - Short Form scale (TC Skinner et al., Diabetologia 2006; 49, 621-628) was administered to participants in both study arms To assess the psychosocial impact of their respective insulin treatment regimens	Baseline, 6- and 12-month follow-up visits
Participant self-reported satisfaction (intervention arm only)	A 5-item structured questionnaire was administered to participants in the intervention group to evaluate their satisfaction with the new insulin regimen, experience of using reusable insulin pens, and their experience of hypo- and hyperglycaemic episodes over the study period	12-month follow-up visit
Feedback from local HCPs on implementation of the study intervention	A 6-item questionnaire was administered to HCPs at the end of the study, to obtain feedback on the training they received, their confidence in teaching youth and families on switching to the new insulin regimen, and opinion on its impact on hypo- and hyperglycaemic episodes.	At 12 months

Collaborators and Investigators

• Sponsor: Life for a Child Program, Diabetes Australia
• Collaborators: University Hospital, Geneva; Centre Hospitalier du Luxembourg; Sante Diabete Mali; Hospital of Mali
• Investigators: Principal Investigator: Stéphane Besançon, MSC, ONG Santé Diabète,Bamako,Mali & Unité PACRI,Conservatoire National des Arts et Métiers,Paris,France

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: children; adolescents; insulin glargine; Mali
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: 2022/27/CE/USTTB; #2208-05490 (Other Grant/Funding Number: The Leona M. and Harry B. Helmsley Charitable Trust)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due local privacy regulations, individual de-identified participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes