Health Condition 1: E10- Type 1 diabetes mellitus
Conditions
Interventions
Intervention1: Twice Daily: Patient will receive Glargine as basal insulin, administered as twice daily in such a way that, half dose will be given at morning time and other half will be given at bed
Sponsors
AIIMS BHOPAL
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children aged 2-18 years living with Type 1 Diabetes Mellitus for at least 6 months 2. On a basal-bolus insulin regimen with glargine as basal insulin for at least 6 months prior to enrolment. 3. HbA1c between above 7.5% at screening. 4. Willing and able to perform self-monitoring of blood glucose (SMBG) at least 4 times daily by the patient or primary caregiver. 5. Willingness to attend regular follow-up visits
Exclusion criteria
Exclusion criteria: 1. Other forms of diabetes like Monogenic diabetes and type 2 DM 2. Known severe renal impairment (eGFR less than 30 mL/min/1.73m2) or hepatic impairment (ALT more than 3 times UL) at the time of screening. 3. Active severe infection or other acute illness (e.g., DKA, hyperosmolar hyperglycaemic state) at the time of screening or within 2 weeks prior, that might interfere with glycemic control or participation. 4. All children with who are eligible, whose parents refuse to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the glycemic control (assessed by HbA1c) in children & adolescent living with Type 1 diabetes mellitus (aged 2-18 years) receiving once-daily glargine versus twice-daily glargine as basal insulin at 3 months.Timepoint: 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the incidence and severity of hypoglycemia documented by SMBG readings/ CGM (overall, nocturnal, and severe) between the two groups.Timepoint: 3 month;To compare the incidence and severity of evening hyperglycemia documented by SMBG readings/ CGM (pre-dinner and post-dinner blood glucose levels) and the occurrence of the dusk phenomenon between the two groups.Timepoint: 3 months;To compare the fasting blood glucose levels and the occurrence of the dawn phenomenon documented by SMBG readings/ CGM between the two groups.Timepoint: 3 months;To compare the total daily dose (TDD) of insulin (basal + bolus) between the two groups at 3 months.Timepoint: 3 months;To compare daily glycemic variability (assessed by standard deviation of blood glucose and/or M-value from SMBG) between the two groups. Timepoint: 3 months;Patients who are on continuous glucose monitor(CGM): To compare Time in Range (TIR), Time Below Range (TBR), Time Above Range (TAR), Glucose Management Indicator (GMI), and Glucose Variability (Standard deviation (SD), coefficient of variation (CV), mean amplitude of glycemic excursion (MAGE), continuous overlapping net glycemic action (CONGA), mean of daily difference for inter-day variation (MODD), high blood glucose index (HBGI), and low blood glucose index (LBGI)) derived from CGM data between the two groupsTimepoint: 3 months | — |
Countries
India
Contacts
Public ContactMUHAMMED SALEEQ PK
AIIMS BHOPAL
Outcome results
None listed