Optimizing diet and insulin regimes in children with Type 1 Diabetes in low-resource settings: An RCT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- DHR
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Absolute reduction in hbA1c percentage from baseline
Study Overview
Brief Summary
In children aged 8-16 years with type 1 diabetes, we propose to study the efficacy of two interventions in improving their glycemic control.
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Standardized, healthy and easy to prepare balanced low glycemic load snacks as mid-meals
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Teaching the skill of counting the carbohydrates in major meals and adjusting the dose of insulin accordingly.
India has 18% of the world’s diabetic children. Although significant advances have been made in the technology for diabetes care including use of continuous subcutaneous insulin infusion by pump and continuous glucose monitoring, our children remain untouched by these due to the high cost. However, detailed patient education and intensive dietary counseling can be effective strategies in low-cost settings that can help in improving diabetes control.
Our hypothesis is that together these two interventions can help in achieving a reduction in HbA1c and reducing episodes of hypo and hyper-glycemia.
The recruitment of children with type 1 diabetes has begun from January 2018. The site is Department of Pediatrics, AIIMS, Delhi. We have modified the age to 6-18 years, and children staying in the neighbouring cities who are willing for regular follow-up are also eligible for enrollment.
Study Design
- Study Type
- Interventional
- Allocation
- Stratified randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 8.00 Year(s) to 16.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •a.Children aged
- •16 years with Type 1 Diabetes b.Diagnosed at least 1 year ago c.Enrolled in and under regular follow-up at Pediatric Endocrinology Clinic, AIIMS d.Resident of Delhi, NCR e.On minimum of 4 daily injections of insulin (long-acting: NPH or glargine or detemir and short acting: regular, lispro, aspart or glulisine) f.Measuring blood glucose at home regularly.
Exclusion Criteria
- •a.Celiac disease b.Both parents illiterate c.Inability to communicate well in both Hindi and English d.Those on insulin pump (continuous subcutaneous insulin infusion).
Outcomes
Primary Outcomes
Absolute reduction in hbA1c percentage from baseline
Time Frame: At 6 months after enrolment
Secondary Outcomes
- Three day continuous glucose monitoring, analysis of proportion of time spent in euglycemia, hyper and hypoglycemia
- Assessment of compliance with prescribed diet, total caloric intake and proportion from carbohydrates, fats and proteins by 3 day dietary recall, food frequency questionnaire and dietary diary