Modifying diet and insulin regimes in children with diabetes to improve blood sugar control
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Type 1 diabetesHealth Condition 2: E10- Type 1 diabetes mellitus
- Registration Number
- CTRI/2017/10/009984
- Lead Sponsor
- DHR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 125
Inclusion Criteria
a.Children aged 8 - 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute reduction in hbA1c percentage from baselineTimepoint: At 6 months after enrolment
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>Timepoint: 6 months;Three day continuous glucose monitoring, analysis of proportion of time spent in euglycemia, hyper and hypoglycemia <br/ ><br>Timepoint: 6 months