A Study to compare glycemic control achieved by Flash Glucose Monitoring and Self Monitoring of blood Glucose in pregnant women with Diabetes Mellitus
Not Applicable
- Conditions
- Health Condition 1: O244- Gestational diabetes mellitusHealth Condition 2: O241- Pre-existing type 2 diabetes mellitus, in pregnancy, childbirth and the puerperium
- Registration Number
- CTRI/2021/05/033551
- Lead Sponsor
- DELHI DIABETIC FORUM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
• Pregnancy complicated with other chronic medical illness.
• Known case of Psychiatric illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of glycemic control after 2 weeks treatment based on glycemic monitoring <br/ ><br>measured by flash glucose monitoring and self- monitoring of blood glucose in pregnant women <br/ ><br>with diabetes mellitus on insulinTimepoint: 2 weeks and 1 month
- Secondary Outcome Measures
Name Time Method 1. Compare Patient satisfaction based on diabetes treatment satisfaction questionnaire <br/ ><br>(DTSQ) between FGM and SMBG groups at the end of 14 days. <br/ ><br>2. To compare serum Fructosamine level at recruitment and at the end of 2 weeks. <br/ ><br>3. To compare sustainability of glycemic control at the end of 4 weeks in both groups by <br/ ><br>measuring mean blood glucose , SD, proportion of women having normoglycemia (70 to <br/ ><br>140mg/dl), Fructosamine and HbA1C level. <br/ ><br>4. Any adverse effect due to FGM will be notedTimepoint: 2 weeks and 1 month