Clinical trial NCT06717191: Impact of Introducing Basaglar Insulin to the Treatment Regimen of Youth with Diabetes in Pakistan
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 Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Keywords: Analog insulin
Basaglar
Pakistan
Children and Adolescents
Type 1 diabetes
insulin pen-devices
Lead sponsor: Life for a Child Program, Diabetes Australia
Sponsor class: OTHER
Collaborators: name: Baqai Institute of Diabetology and Endocrinology
First posted: 2024-12-04
Enrollment: 296
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean and median HbA1c (% and mmol/mol)
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: Proportion of participants experiencing episodes of diabetic ketoacidosis
timeFrame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
Secondary outcomes:
measure: Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
timeFrame: Baseline, 6- and 12-month follow-up visits
Other outcomes:
measure: Participant self-reported satisfaction
timeFrame: 12-month follow-up visit
Locations:
city: Karachi
country: Pakistan
facility: Baqai Institute of Diabetology and Endocrinology (BIDE)
state: Sindh
Study officials:
affiliation: Baqai Insitute of Diabetology and Endocrinology (BIDE)
name: Prof. Asher Fawwad
role: PRINCIPAL_INVESTIGATOR
References: