A Phase 4 interventional study of biosimilar insulin glargine in Type I Diabetes, sponsored by Life for a Child Program, Diabetes Australia. Completed at 1 site in Bangladesh. Open to participants aged 10 Years to 25 Years. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Life for a Child Program, Diabetes Australia · Phase 4, Interventional, and Treatment
This study aimed to determine the effect of introducing Basaglar and insulin pen injection devices on clinical and quality of life (QOL) parameters in children and young adults with type 1 diabetes in Bangladesh
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) provides diabetes supplies (insulin, syringes, meters and strips for blood glucose self-monitoring), diabetes-related education, mentoring and technical support to the team managing youth with type 1 diabetes (T1D) managed at the Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM) Hospital in Dhaka, Bangladesh. In 2022, 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 Bangladesh.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 202 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
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
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
Also known as: Basaglar
Mean and median HbA1c (% and mmol/mol)
HbA1c was measured at each study time point using the Minicap Sebia Autoanalyzer with venous blood
Time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
Proportion of participants experiencing 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 ketonaemia and ketonuria
Time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
Proportion of participants experiencing episodes of severe hypoglycaemia
Severe hypoglycaemia 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
Time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
The 21- item Diabetes Quality of Life in Youth - Short Form scale \[1\] was administered to participants to assess their health-related quality of life after the change in their insulin treatment regimen. Each item has 5 possible scores with a value from 0 to 4, with 0 representing "never" and 4 "all the time". Higher scores represent a higher impact of diabetes and a poorer quality of life; lower scores indicate greater quality of life. The highest possible score is 84 (21 x 4 i.e. "all the time" for all 21 items) and lowest possible score is 0 (21 x 0 i.e. "never" for all 21 items)
Time frame: Baseline, 6- and 12-month follow-up visits
Participant self-reported satisfaction
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
Time frame: 12-month follow-up visit
Plan to share: No — Due local privacy regulations, individual de-identified participant data will not be shared
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Life for a Child Program, Diabetes Australia