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Effect of after-meal bolus insulin injection on sugar control among children with diabetes

Effect of post-meal Fast acting Insulin Aspart on frequency of hypoglycaemia among preschool children with Type 1 Diabetes Mellitus: An open-label cross-over randomised control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028750
Enrollment
64
Registered
2020-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: E108- Type 1 diabetes mellitus with unspecified complications

Interventions

Intervention1: Post-meal insulin injection of meal bolus: Fast acting insulin Aspart will be given post meal instead of pre-meal standard practice Control Intervention1: Pre-meal insulin injection bol

Sponsors

Department of Pediatrics PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Duration of disease- >6 months 2) Already on basal-bolus MDI regimen with pre-meal rapid acting insulin analogues and basal insulin with long acting analogues AND doing self-monitoring of blood glucose (SMBG) for 4 times/day or on continuous glucose monitoring (CGM) 3) HbA1c 4) Parents well conversant with basal- bolus dose adjustments on daily basis.

Exclusion criteria

Exclusion criteria: 1) Non-compliant to therapy 2) Not giving consent for participation in the trial

Design outcomes

Primary

MeasureTime frame
Frequency of hypoglycemiaTimepoint: 3 and 6 months

Secondary

MeasureTime frame
1) Parental satisfaction 2) Quality of life improvement 3) Overall glycemic control, number of hospital visits due to dysglycemia, frequency of hyperglycemic episodes etc 4) Total daily dose; Bolus dose; Basal dose of insulin (Units/kg/day) 5) Any adverse events related to postmeal injection Timepoint: 3 and 6 months

Countries

India

Contacts

Public ContactArti Yadav

Postgraduate Institute of Medical Education and Research, Chandigarh

drrakesh.pgi@gmail.com91-70870-08480

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026