Clinical trial NCT06624943: Introducing Biosimilar Insulin Glargine to the Treatment Regimen of Children and Youth with Type 1 Diabetes in Mali
Official title: Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Mali
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes (T1D)
Keywords: children
adolescents
insulin glargine
Mali
Lead sponsor: Life for a Child Program, Diabetes Australia
Sponsor class: OTHER
Collaborators: name: Sante Diabete Mali
name: Hospital of Mali
name: Centre Hospitalier du Luxembourg
name: University Hospital, Geneva
First posted: 2024-10-03
Enrollment: 260
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
Secondary outcomes:
measure: Episodes of diabetic ketoacidosis
timeFrame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
measure: Episodes of severe hypoglycaemia
timeFrame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
measure: Diabetes Quality of Life in Youth - Short Form
timeFrame: Baseline, 6- and 12-month follow-up visits
measure: Participant self-reported satisfaction (intervention arm only)
timeFrame: 12-month follow-up visit
measure: Feedback from local HCPs on implementation of the study intervention
timeFrame: At 12 months
Other outcomes:
Locations:
city: Bamako
country: Mali
facility: Hôpital du Mali
Study officials:
affiliation: ONG Santé Diabète,Bamako,Mali & Unité PACRI,Conservatoire National des Arts et Métiers,Paris,France
name: Stéphane Besançon, MSC
role: PRINCIPAL_INVESTIGATOR
References: