To evaluate whether personalized dietary and physical activity advice based on CGMS data would be effective in preventing the occurrence of gestational diabetes mellitus in high risk women.

Evaluating the utility of continuous glucose monitoring system for behavioral modification in high risk women enrolled in early pregnancy for the prevention of gestational diabetes mellitus a pilot Randomized Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071323

Enrollment

120

Registered

2024-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Continuous Glucose Monitoring System: Women allocated to intervention arm will undergo 2 weeks of continuous glucose monitoring and will be asked to record (take photos) of all that the

Eligibility

Inclusion criteria

Inclusion criteria: Women 18 years or older in early pregnancy with period of gestation less than 14 weeks. The participant should have one or more risk factors for gestational diabetes mellitus. The patient should have a BMI more than equal to 25 kilogram per meter square or BMI more than or equal to 23 Kilogram per meter square with hypertension or history of PCOS or previous history of gestational diabetes mellitus or family history of diabetes in first degree relative or age more than 35 years. The patient should have a singleton pregnancy confirmed by ultrasonography and should be enrolled either in the Department of Endocrinology and Metabolism or Department of Obstetrics and Gynaecology AIIMS Delhi. The participant should also be willing to comply with the study protocol.

Exclusion criteria

Exclusion criteria: Women with Type 1 diabetes mellitus secondary diabetes or overt and pre-existing diabetes or gestational diabetes defined as per WHO 2019 criteria. The participant should not have any systemic illness with major organ dysfunction and should not be on steroids. Women with eczema or with a skin condition which precludes using a continuous glucose monitoring device will also be excluded. Women who do not have a smartphone as diet pictures have to be shared on real time basis.

Design outcomes

Primary

Measure	Time frame
Difference in the incidence of gestational diabetes mellitus between the intervention and control groupsTimepoint: At 28 weeks period of gestation	—

Secondary

Measure	Time frame
Difference in between the two groups in appropriate gestational weight gain both total and per week.Timepoint: At baseline, between 24 to 28 weeks period of gestation, between 34-38 weeks period of gestation and at delivery.;Difference in composite pregnancy outcome which will be a composite of neonate born large for gestational age gestational hypertension or pre-eclampsia, small for gestational age, Apgar score less than 7, hyperbilirubinemia, respiratory distress syndrome, clinically significant neonatal hypoglycemia, preterm birth, perinatal mortality, NICU admission for more than 24 hours Timepoint: At delivery;Likely recommendation for use in other pregnant women by the participantTimepoint: At delivery;Participant satisfaction with full intervention processTimepoint: At delivery;Participant satisfaction with the use of CGMSTimepoint: At baseline and between 24-28 weeks;Perceived benefit of tailored behavioral modification advice by the participantTimepoint: At delivery;Percentage of women adherent to all six assessment visits.Timepoint: At delivery.;Percentage of women who scanned periodically and provided more than 70% of the CGMS dataTimepoint: At baseline and between 24 to 28 weeks period of gestation;Percentage of women who shared the data of their diet for at least 70% of their mealsTimepoint: At baseline and between 24 to 28 weeks period of gestation;Percentage of women who wore CGMS for the entire duration of two weeksTimepoint: At baseline and between 24 to 28 weeks period of gestation	—

Measure

Time frame

Difference in between the two groups in appropriate gestational weight gain both total and per week.Timepoint: At baseline, between 24 to 28 weeks period of gestation, between 34-38 weeks period of gestation and at delivery.;Difference in composite pregnancy outcome which will be a composite of neonate born large for gestational age gestational hypertension or pre-eclampsia, small for gestational age, Apgar score less than 7, hyperbilirubinemia, respiratory distress syndrome, clinically significant neonatal hypoglycemia, preterm birth, perinatal mortality, NICU admission for more than 24 hours Timepoint: At delivery;Likely recommendation for use in other pregnant women by the participantTimepoint: At delivery;Participant satisfaction with full intervention processTimepoint: At delivery;Participant satisfaction with the use of CGMSTimepoint: At baseline and between 24-28 weeks;Perceived benefit of tailored behavioral modification advice by the participantTimepoint: At delivery;Percentage of women adherent to all six assessment visits.Timepoint: At delivery.;Percentage of women who scanned periodically and provided more than 70% of the CGMS dataTimepoint: At baseline and between 24 to 28 weeks period of gestation;Percentage of women who shared the data of their diet for at least 70% of their mealsTimepoint: At baseline and between 24 to 28 weeks period of gestation;Percentage of women who wore CGMS for the entire duration of two weeksTimepoint: At baseline and between 24 to 28 weeks period of gestation

—

Countries

India

Contacts

Public ContactDr Yashdeep Gupta

All India Institute of Medical Sciences, New Delhi

aakansha.0701@gmail.com9650746218

Outcome results