Health Condition 1: E108- Type 1 diabetes mellitus with unspecified complications
Conditions
Interventions
Sponsors
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
| Measure | Time frame |
|---|---|
| Frequency of hypoglycemiaTimepoint: 3 and 6 months | — |
Secondary
| Measure | Time 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
Postgraduate Institute of Medical Education and Research, Chandigarh