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 Australia

Status and phase: Completed; Phase 4

Conditions: Type I Diabetes

Treatments: Drug: biosimilar insulin glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT06674135

BADAS-ERC/EC/22/00325

Details and patient eligibility

About

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

Full 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.

Enrollment: 202 patients

Sex: All

Ages: 10 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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202 participants in 1 patient group

Introduction of Basaglar to insulin treatment regimen

Experimental group

Description:

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

Treatment:

Drug: biosimilar insulin glargine