Type 1 Diabetes
Conditions
Keywords
Analog insulin, Basaglar, Pakistan, Children and Adolescents, Type 1 diabetes, insulin pen-devices
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.
Interventions
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
Sponsors
Baqai Institute of Diabetology and Endocrinology
Life for a Child Program, Diabetes Australia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participant self-reported satisfaction | 12-month follow-up visit | A 5-item structured questionnaire was administered to participants in the intervention group to evaluate their satisfaction with the new insulin regimen, experience of using reusable insulin pens, and their experience of hypo- and hyperglycaemic episodes over the study period |
Countries
Pakistan
Outcome results
None listed