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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy in Diabetic

Intervention / Treatment
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* Device: Continuous glucose monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old. Pregnant women without diabetes. Pregnant women with diabetes (pregestational and gestational) on diet +/- metformin. Dedicated to applying a continuous glucose monitoring (CGM) device. Exclusion Criteria: Age below18 years Pregnant women with diabetes on insulin (type 1 and type 2 diabetes) Renal and liver impairment. Adrenal insufficiency Psychiatric diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Pregnancy<br>Pregnant women with no diabetes | Device: Continuous glucose monitoring<br>* Home continuous glucose monitoring to be installed for two weeks during fasting Ramadan<br>|
| Gestational diabetes on diet alone<br> | Device: Continuous glucose monitoring<br>* Home continuous glucose monitoring to be installed for two weeks during fasting Ramadan<br>|
| Gestational diabetes on diet + Metformin therapy<br> | Device: Continuous glucose monitoring<br>* Home continuous glucose monitoring to be installed for two weeks during fasting Ramadan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose variability during fasting Ramadan | To estimate the difference in the groups in glucose variability | 1 month | 
| 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 | 
| 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 | 
| Time above range (TAR) | TAR that defined as blood glucose range >140 mg/dl (>7.8 mmol/L) according to ADA guideline. | 1 month | 
| Time below range (TBR) | TBR that defined as blood glucose range < 60 mg/dl | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnant, gestational diabetes, fasting