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| ID | Type | Description | Link |
|---|---|---|---|
| #2208-05490 | Other Grant/Funding Number | The Leona M. and Harry B. Helmsley Charitable Trust |
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| Name | Class |
|---|---|
| Sante Diabete Mali | OTHER |
| Hospital of Mali | UNKNOWN |
| Centre Hospitalier du Luxembourg | OTHER |
| University Hospital, Geneva |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Continue current treatment with either intermediate- and short-acting human insulin, or pre-mixed insulin, both via needle and syringe | |
| Intervention | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biosimilar insulin glargine | Drug | Once daily injection of biosimilar insulin glargine via reusable pen |
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| 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 Vantageâ„¢ 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 |
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane Besançon, MSC | ONG Santé Diabète,Bamako,Mali & Unité PACRI,Conservatoire National des Arts et Métiers,Paris,France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital du Mali | Bamako | Mali |
Due local privacy regulations, individual de-identified participant data will not be shared.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 30, 2025 | Aug 14, 2025 | 1 | ||
| Oct 6, 2025 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| OTHER |
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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 |
| Oct 21, 2025 |
| 2 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |