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Modifying diet and insulin regimes in children with diabetes to improve blood sugar control

Optimizing diet and insulin regimes in children with Type 1 Diabetes in low-resource settings: An RCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/009984
Enrollment
150
Registered
2017-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 1 diabetes Health Condition 2: E10- Type 1 diabetes mellitus

Interventions

Intervention1: Healthy balanced low GI snacks and carbohydrate counting: a. Substituting unhealthy with easy to prepare balanced mid-meal snacks with low glycemic load b.Teaching the skill of countin

Sponsors

DHR
Lead Sponsor
AIIMS Delhi
Collaborator

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Absolute reduction in hbA1c percentage from baselineTimepoint: At 6 months after enrolment

Secondary

MeasureTime frame
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 Timepoint: 6 months;Three day continuous glucose monitoring, analysis of proportion of time spent in euglycemia, hyper and hypoglycemia Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Vandana Jain

AIIMS, New Delhi

drvandanajain@gmail.com9810167265

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026