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A Study to compare glycemic control achieved by Flash Glucose Monitoring and Self Monitoring of blood Glucose in pregnant women with Diabetes Mellitus

Comparison of Flash Glucose Monitoring and Conventional Self-Monitoring of Blood Glucose for achieving glycemic control in pregnant women with Diabetes Mellitus on insulin â?? A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033551
Enrollment
70
Registered
2021-05-11
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: O244- Gestational diabetes mellitus Health Condition 2: O241- Pre-existing type 2 diabetes mellitus, in pregnancy, childbirth and the puerperium

Interventions

Intervention1: FLASH GLUCOSE MONITORING DEVICE (FGM is being manufactured by ABBOTT Diabetes care by the name of Freestyle Libre Pro) : Pregnant women with diabetes on insulin will undergo continuous

Sponsors

DELHI DIABETIC FORUM
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: .Diagnosed cases of pregnancy with diabetes mellitus (including both GDM and overt DM) on insulin therapy. • Period of gestation 24-36 weeks of gestation. • Singleton pregnancy. • Women who can understand hindi / English and can keep a diet diary and insulin chart and are willing to follow the study protocol.

Exclusion criteria

Exclusion criteria: • Pregnancy complicated with other chronic medical illness. • Known case of Psychiatric illness.

Design outcomes

Primary

MeasureTime frame
Comparison of glycemic control after 2 weeks treatment based on glycemic monitoring measured by flash glucose monitoring and self- monitoring of blood glucose in pregnant women with diabetes mellitus on insulinTimepoint: 2 weeks and 1 month

Secondary

MeasureTime frame
1. Compare Patient satisfaction based on diabetes treatment satisfaction questionnaire (DTSQ) between FGM and SMBG groups at the end of 14 days. 2. To compare serum Fructosamine level at recruitment and at the end of 2 weeks. 3. To compare sustainability of glycemic control at the end of 4 weeks in both groups by measuring mean blood glucose , SD, proportion of women having normoglycemia (70 to 140mg/dl), Fructosamine and HbA1C level. 4. Any adverse effect due to FGM will be notedTimepoint: 2 weeks and 1 month

Countries

India

Contacts

Public ContactGunjan

Lady Hardinge Medical College

pikeesaxena@hotmail.com9868223323

Outcome results

None listed

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