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

Phase 4

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: biosimilar insulin glargine

• Registration Number: NCT06717191
• Lead Sponsor: Life for a Child Program, Diabetes Australia

Brief Summary

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

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) 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.

Study Timeline

• Study Start: 2022-06-09
• Primary Completion: 2024-06-15
• Study Completion: 2024-08-02
• Status Verified: 2024-12
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-01
• Last Update Submitted: 2024-12-01
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Introduction of Basaglar to insulin treatment regimen	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

Primary Outcome Measures

Name	Time	Method
Mean and median HbA1c (% and mmol/mol)	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))
Proportion of participants experiencing episodes of severe hypoglycaemia	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
Proportion of participants experiencing 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 ketonaemia and ketonuria

Secondary Outcome Measures

Name	Time	Method
Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)	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)

Trial Locations

Locations (1)

Baqai Institute of Diabetology and Endocrinology (BIDE); 🇵🇰 Karachi, Sindh, Pakistan