Comparison of lifestyle modification with routine care and comparison of benefit of use of technology with usual care

Not Applicable

Conditions: Health Condition 1: O241- Pre-existing type 2 diabetes mellitus, in pregnancy, childbirth and the puerperium

Registration Number: CTRI/2023/06/053949

Lead Sponsor: Department of Endocrinology and Metabolism

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Pregnant women with type 2 Diabetes Mellitus (period of gestation <15 weeks)

2.Pregnant women with overt diabetes but diagnosed before 12 weeks of pregnancy. As per ADA guidelines, these women usually have pre-existing type 2 diabetes.

3.Live singleton fetus (US done to confirm gestational age, viability and rule out multiple pregnancy)

4.Age >= 18 years and less than 50 years

5.Enrolled either in Department of Endocrinology and Metabolism or Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi.

6.Willing to comply with study protocol

Exclusion Criteria

1.Type 1 diabetes mellitus, secondary diabetes gestational diabetes mellitus

2.Have used CGMS in the previous 3 months

3.Inflammatory or connective tissue disorders requiring or required use of immunosuppressive or steroids or disease-modifying agents in the past â?¡ 4.Chronic organ diseases affecting heart, lung, kidney, liver, brain.

5.HBsAg, Anti-HCV or HIV positive

6.Active infection

7.Diseases/conditions or drugs that may result in hyperglycemia as per ADA classification will also be excluded.

8.Psychiatric or any other issues, which may interfere with the study compliance, as judged by the investigators.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of change in Hb1Ac from randomisation to 34-38 weeks gestation. <br/ ><br> <br/ ><br>Timepoint: From randomisation(less than 15 weeks) to 34-38 weeks gestation. <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
<br/ ><br> Hb1AcTimepoint: At 24-28 weeks;Composite pregnancy outcomeTimepoint: At delivery;DepressionTimepoint: At 34-38 weeks;Gestational weight gain/weekTimepoint: From 16 weeks to 24-38 weeks;Individual maternal and neonatal outcomesTimepoint: At delivery;Proportion of values in target for preceding 2 weeks collected at visits baseline, 24-28, 34-38 weeks. Target Pre-meals less than 100 mg/dl, Post-meals less than 127 mg/dl <br/ ><br>Timepoint: At 34-38 weeks