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

NCT ID: NCT06674135

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-08-31

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 Bangladesh

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 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.

Conditions

Type I Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Introduction of Basaglar to insulin treatment regimen

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

Group Type: EXPERIMENTAL

biosimilar insulin glargine

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Basaglar

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

BADAS-Centre for Health Research and Implementation

UNKNOWN

Sponsor Role: collaborator

Diabetic Association of Bangladesh (BADAS)

UNKNOWN

Sponsor Role: collaborator

Life for a Child Program, Diabetes Australia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Bedowra Zabeen, MBBS, FCPS(Paediatrics), FRSPH

Role: PRINCIPAL_INVESTIGATOR

Life For a Child Program, BIRDEM, BADAS, Bangladesh

Locations

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

Dhaka, , Bangladesh

Countries

Bangladesh

References

Skinner TC, Hoey H, McGee HM, Skovlund SE; Hvidore Study Group on Childhood Diabetes. A short form of the Diabetes Quality of Life for Youth questionnaire: exploratory and confirmatory analysis in a sample of 2,077 young people with type 1 diabetes mellitus. Diabetologia. 2006 Apr;49(4):621-8. doi: 10.1007/s00125-005-0124-0. Epub 2006 Jan 26.

Reference Type: BACKGROUND

PMID: 16525844 (View on PubMed)

Other Identifiers

BADAS-ERC/EC/22/00325

Identifier Type: -

Identifier Source: org_study_id