Pregnancy in Diabetic
Conditions
Keywords
Pregnant, gestational diabetes, fasting
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.
Interventions
DEVICEContinuous glucose monitoring
Home continuous glucose monitoring to be installed for two weeks during fasting Ramadan
Sponsors
King Abdullah International Medical Research Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
Countries
Saudi Arabia
Outcome results
None listed