Clinical trial 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
Official title: Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type I Diabetes
Keywords: Analog insulin
Basaglar
Bangladesh
Children and Adolescents
Type 1 diabetes
insulin pen-devices
Lead sponsor: Life for a Child Program, Diabetes Australia
Sponsor class: OTHER
Collaborators: name: Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
name: BADAS-Centre for Health Research and Implementation
name: Diabetic Association of Bangladesh (BADAS)
First posted: 2024-11-05
Enrollment: 202
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean and median HbA1c (% and mmol/mol)
timeFrame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
Secondary outcomes:
measure: Proportion of participants experiencing episodes of diabetic ketoacidosis
timeFrame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
measure: Proportion of participants experiencing episodes of severe hypoglycaemia
timeFrame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
measure: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
timeFrame: Baseline, 6- and 12-month follow-up visits
measure: Participant self-reported satisfaction
timeFrame: 12-month follow-up visit
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: BIRDEM, the Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
Study officials:
affiliation: Life For a Child Program, BIRDEM, BADAS, Bangladesh
name: Dr Bedowra Zabeen, MBBS, FCPS(Paediatrics), FRSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.