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Completed

NCT Number: NCT06674135

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

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

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Key information

Conditions

Type I Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Dhaka, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biosimilar insulin glargine

Drug

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

Other names: Basaglar

Primary outcomes

  1. Mean and median HbA1c (% and mmol/mol)

    Time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits

    HbA1c was measured at each study time point using the Minicap Sebia Autoanalyzer with venous blood

Secondary outcomes

  1. Proportion of participants experiencing episodes of diabetic ketoacidosis

    Time frame: 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 ketonaemia and ketonuria

  2. Proportion of participants experiencing episodes of severe hypoglycaemia

    Time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits

    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

  3. Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)

    Time frame: Baseline, 6- and 12-month follow-up visits

    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)

  4. Participant self-reported satisfaction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Life for a Child Program, Diabetes Australia

Other

Collaborators

  • BADAS-Centre for Health Research and Implementation
  • Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
  • Diabetic Association of Bangladesh (BADAS)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 5, 2024
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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