Health Condition 1: O241- Pre-existing type 2 diabetes mellitus, in pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention1: Behavioural intervention: Video assisted group sessions on diet and exercise
Duration:till delivery(approximately 9 months)
Intervention2: Technological intervention: Use of CGMS(Conti
Sponsors
Department of Endocrinology and Metabolism
Eligibility
Inclusion criteria
Inclusion criteria: 1.Pregnant women with type 2 Diabetes Mellitus (period of gestation 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of change in Hb1Ac from randomisation to 34-38 weeks gestation. Timepoint: From randomisation(less than 15 weeks) to 34-38 weeks gestation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: At 34-38 weeks | — |
Countries
India
Contacts
Public ContactAdarsh Pal
All India Institute of Medical Sciences,New Delhi
Outcome results
None listed