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

Pregnancy in Diabetic Clinical Trial

Official title:

Incidence of Hypoglycemia in Pregnant Women With or Without Diabetes During Fasting in Ramadan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04862390
• Other study ID #: NRJ21J/034/02
• Status: Completed
• Start date: March 28, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: January 2022
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2021
• Est. primary completion date: June 27, 2021
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoglycemia
• Pregnancy in Diabetic
• Pregnancy in Diabetics

Intervention

Device:
• Continuous glucose monitoring
Home continuous glucose monitoring to be installed for two weeks during fasting Ramadan

Locations

Country	Name	City	State
Saudi Arabia	KingAbullahIMRC	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoglycemia incidence with fasting	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	1 month
Secondary	Glucose variability during fasting Ramadan	To estimate the difference in the groups in glucose variability	1 month
Secondary	Number of days that needed to break fasting	To estimate the difference in the groups in number of days that needed to break fasting	1 month
Secondary	Time in range (TIR)	TIR is defined as blood glucose range between 63-140 mg/dl (3.5-7.8 mmol/L) according to ADA guideline.	1 month
Secondary	Time above range (TAR)	TAR that defined as blood glucose range >140 mg/dl (>7.8 mmol/L) according to ADA guideline.	1 month
Secondary	Time below range (TBR)	TBR that defined as blood glucose range < 60 mg/dl	1 month