Type 1 Diabetes (T1D)
Conditions
Keywords
children, adolescents, insulin glargine, Mali
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.
Interventions
Once daily injection of biosimilar insulin glargine via reusable pen
Sponsors
Sante Diabete Mali
Hospital of Mali
Centre Hospitalier du Luxembourg
University Hospital, Geneva
Life for a Child Program, Diabetes Australia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Baseline, 3-, 6-, 9- and 12-month follow-up visits | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Episodes of diabetic ketoacidosis | Baseline, 3-, 6-, 9- and 12-month follow-up visits | 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 |
| Episodes of severe hypoglycaemia | Baseline, 3-, 6-, 9- and 12-month follow-up visits | 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 |
| Diabetes Quality of Life in Youth - Short Form | Baseline, 6- and 12-month follow-up visits | 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 |
| Participant self-reported satisfaction (intervention arm only) | 12-month follow-up visit | 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 |
| Feedback from local HCPs on implementation of the study intervention | At 12 months | 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. |
Countries
Mali
Outcome results
None listed