Incidence of Hypoglycemia in Pregnant Ladies With or Without Gestational Diabetes Fasting Ramadan

Completed

• Conditions: Pregnancy in Diabetic
• Interventions: Device: Continuous glucose monitoring

• Registration Number: NCT04862390
• Lead Sponsor: King Abdullah International Medical Research Center

Brief Summary

The physiological change in food and sleep pattern during Ramadan impacted hypoglycemia risks among pregnant women. Few studies investigated the incidence of hypoglycemia pregnant women with or without diabetes during fasting in Ramadan in Saudi Arabia. This study aims to understand the glucose variability in pregnant women during fasting Ramadan in Saudi Arabia.

Detailed Description

Women with normal pregnancy will be compared to women with gestational diabetes on diet or Metformin alone during Fasting Ramadan. They will be monitored and will be observed for incidence of hypoglycemia using continuous glucose monitoring devices.

Study Timeline

• Study Start: 2021-03-28
• Study First Submitted: 2021-04-25
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-28
• Primary Completion: 2021-06-27
• Study Completion: 2021-08-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Age > 18 years old.
2. Pregnant women without diabetes.
3. Pregnant women with diabetes (pregestational and gestational) on diet +/- metformin.
4. Dedicated to applying a continuous glucose monitoring (CGM) device.

Exclusion Criteria

1. Age below18 years
2. Pregnant women with diabetes on insulin (type 1 and type 2 diabetes)
3. Renal and liver impairment.
4. Adrenal insufficiency
5. Psychiatric diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Pregnancy	Continuous glucose monitoring	Pregnant women with no diabetes
Gestational diabetes on diet alone	Continuous glucose monitoring	-
Gestational diabetes on diet + Metformin therapy	Continuous glucose monitoring	-

Primary Outcome Measures

Name	Time	Method
Hypoglycemia incidence with fasting	1 month	To estimate the incidence of hypoglycemia defined as blood glucose \< 70 mg/dl during fasting in pregnant women with gestational diabetes on diet therapy or metformin alone compared to women without diabetes

Secondary Outcome Measures

Name	Time	Method
Time above range (TAR)	1 month	TAR that defined as blood glucose range \>140 mg/dl (\>7.8 mmol/L) according to ADA guideline.
Time below range (TBR)	1 month	TBR that defined as blood glucose range \< 60 mg/dl
Time in range (TIR)	1 month	TIR is defined as blood glucose range between 63-140 mg/dl (3.5-7.8 mmol/L) according to ADA guideline.
Glucose variability during fasting Ramadan	1 month	To estimate the difference in the groups in glucose variability
Number of days that needed to break fasting	1 month	To estimate the difference in the groups in number of days that needed to break fasting

Trial Locations

Locations (1)

KingAbullahIMRC; 🇸🇦 Jeddah, Saudi Arabia