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Clinical Trials/CTRI/2023/06/053949
CTRI/2023/06/053949
Not yet recruiting
未知

To evaluate the effectiveness of enhanced behavioural intervention and use of technology (Continuous glucose monitoring) for improving pregnancy outcomes in women with type 2 Diabetes mellitus: A three-arm parallel Randomised Controlled Trialâ??

Department of Endocrinology and Metabolism0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: O241- Pre-existing type 2 diabetes mellitus, in pregnancy, childbirth and the puerperium

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: O241- Pre-existing type 2 diabetes mellitus, in pregnancy, childbirth and the puerperium
Sponsor
Department of Endocrinology and Metabolism
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Department of Endocrinology and Metabolism

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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