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Completed

NCT Number: NCT06717191

Impact of Introducing Basaglar Insulin to the Treatment Regimen of Youth With Diabetes in Pakistan

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 Pakistan

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Key information

Conditions

Type 1 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

Up to 25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baqai Institute of Diabetology and Endocrinology (BIDE)

Karachi, Sindh, 74600, Pakistan

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 Baqai Institute of Diabetology and Endocrinology (BIDE) in Karachi, Pakistan. 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 Pakistan.

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 according to a combination of clinical (polyuria, polydipsia, and weight loss) and biochemical characteristics (High blood glucose levels (fasting glucose ≥ 126 mg/dL or random glucose ≥ 200 mg/dL) and/or C-peptide levels indicating low insulin production, along with the presence of islet autoantibodies (e.g., GAD65, IA-2))
  • Duration of T1D ≥ 12 months at time of enrolment
  • Willing to conduct self-monitoring of blood glucose (SMBG) at least twice daily
  • No prior use of analog insulin (either long-acting or short-acting)
  • Attending BIDE for their routine diabetes care and management
  • No history of other significant medical conditions (e.g., severe renal disease or other autoimmune conditions)
  • Willing to adhere to the study protocol, including attending follow-up visits and participating in the required education sessions

Exclusion criteria

  • Prior use of analog insulin
  • Other medical conditions that would interfere with study participation

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 High Performance Liquid Chromatography (HPLC (BIO-RAD, D10))

  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. 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

Secondary outcomes

  1. 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)

Other outcomes

  1. 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

  • Baqai Institute of Diabetology and Endocrinology

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2024
Registry last updated
Jul 30, 2025

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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