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

Life for a Child Program, Diabetes Australia202 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

202

Conditions

Type I Diabetes

Interventions

biosimilar insulin glargineDRUG

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

Eligibility

Sex: ALLMin age: 10 YearsMax age: 25 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with type 1 diabetes (T1D). Diabetes was diagnosed in accordance with World Health Organization (WHO) criteria. Determination of diabetes type was made by the local investigators according to available clinical features and history: T1D was diagnosed upon abrupt onset of typical symptoms of diabetes with insulin required from diagnosis, and no acanthosis nigricans. They were usually non-obese. * Duration of T1D at enrolment \>12 months * Aged 10-25 years (inclusive) at time of enrolment * Current insulin regimen consisting of Humulin NPH® and R, or pre-mixed insulin (30/70 R/NPH), with no prior use of analogue insulin * Attending Life for a Child, BIRDEM Hospital, Dhaka for their usual diabetes care Exclusion Criteria: • Previous use of analog insulin

Locations (1)

BIRDEM, the Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders

Dhaka, Bangladesh

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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