A study comparing glucose sensor monitoring with routine finger-prick testing to understand blood sugar changes in children with type 1 diabetes

Comparison of continuous glucose monitoring plus self-monitoring of blood glucose versus self-monitoring of blood glucose alone on glycemic variability in children with type 1 diabetes - a randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102241

Enrollment

Registered

2026-01-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: E109- Type 1 diabetes mellitus without complications

Interventions

Intervention1: Intermittent scanned continuous glucose monitoring for 15 days followed by self monitoring of blood glucose: Participants randomized to the intervention group will use an intermittently

Eligibility

Inclusion criteria

Inclusion criteria: Children with type 1 diabetes for more than one year On MDI regimen (basal-bolus) for more than 6 months HbA1c between 7.0% -10.0% Willing to use CGM/SMBG and attend follow-up for the next 3 months

Exclusion criteria

Exclusion criteria: DKA in the last 3 months Cognitive/psychiatric disorders impairing adherence Any comorbid conditions significantly affecting glycemic control Children with anemia, hemoglobinopathies.

Design outcomes

Primary

Measure	Time frame
To compare the change in glycemic variability, as measured by the coefficient of variation (%CV) of glucose levels, at the end of 3 months between children with Type 1 Diabetes using intermittent scanned continuous glucose monitoring (isCGM) for 15 days followed by SMBG, versus those using SMBG alone.Timepoint: Three months	—

Secondary

Measure	Time frame
To estimate and compare additional glycemic variability metrics between the intermittent scanned CGM plus SMBG group and the SMBG-only group at 3 months using structured SMBG data. The metrics to be assessed include estimated blood glucose in range (IR), defined as the percentage of readings between 70 180 mg/dL; below range (BR), defined as the percentage of readings less than 70 mg/dL; and above range (AR), defined as the percentage of readings greater than 180 mg/dL and greater than 250 mg/dL. Additionally, the study will compare the proportion of children achieving a coefficient of variation (CV) of less than 36% at the end of 3 months between the two groups.Timepoint: Three months;To compare the change in HbA1c levels from baseline to 3 months between children with Type 1 diabetes randomized to limited (15-day) use of intermittent scanned CGM followed by SMBG versus those with SMBG alone.Timepoint: Three months;To evaluate the correlation of glycemic variability with HbA1c in both groups during the study period.Timepoint: Three months;To assess the number and nature of treatment modifications (such as changes in insulin dosing, dietary planning, ability to recognize and manage hypoglycemic and hyperglycemic events, and physical activity) prompted by the intermittent scanned CGM group compared to routine SMBG-based decision-making.Timepoint: Three months;To assess any adverse effects of the use of CGM and its acceptability among children with Type 1 diabetes.Timepoint: Three months	—

Measure

Time frame

To estimate and compare additional glycemic variability metrics between the intermittent scanned CGM plus SMBG group and the SMBG-only group at 3 months using structured SMBG data. The metrics to be assessed include estimated blood glucose in range (IR), defined as the percentage of readings between 70 180 mg/dL; below range (BR), defined as the percentage of readings less than 70 mg/dL; and above range (AR), defined as the percentage of readings greater than 180 mg/dL and greater than 250 mg/dL. Additionally, the study will compare the proportion of children achieving a coefficient of variation (CV) of less than 36% at the end of 3 months between the two groups.Timepoint: Three months;To compare the change in HbA1c levels from baseline to 3 months between children with Type 1 diabetes randomized to limited (15-day) use of intermittent scanned CGM followed by SMBG versus those with SMBG alone.Timepoint: Three months;To evaluate the correlation of glycemic variability with HbA1c in both groups during the study period.Timepoint: Three months;To assess the number and nature of treatment modifications (such as changes in insulin dosing, dietary planning, ability to recognize and manage hypoglycemic and hyperglycemic events, and physical activity) prompted by the intermittent scanned CGM group compared to routine SMBG-based decision-making.Timepoint: Three months;To assess any adverse effects of the use of CGM and its acceptability among children with Type 1 diabetes.Timepoint: Three months

—

Countries

India

Contacts

Public ContactDr Preeti Singh

Kalawati Saran Childrens Hospital

drpreetisingh3@gmail.com981052515

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026