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

King Abdullah International Medical Research Center

Status: Completed

Conditions: Pregnancy in Diabetic

Treatments: Device: Continuous glucose monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT04862390

NRJ21J/034/02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 3 patient groups

Normal Pregnancy

Description:

Pregnant women with no diabetes

Treatment:

Device: Continuous glucose monitoring

Gestational diabetes on diet alone

Treatment:

Device: Continuous glucose monitoring

Gestational diabetes on diet + Metformin therapy

Treatment:

Device: Continuous glucose monitoring