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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Pregnancy | Pregnant women with no diabetes |
| |
| Gestational diabetes on diet alone |
| ||
| Gestational diabetes on diet + Metformin therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring | Device | Home continuous glucose monitoring to be installed for two weeks during fasting Ramadan |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant ladies without gestational diabetes (GDM) and with GDM on diet or metformin attending the endocrine and obstetric clinics at National Guards Hospital Jeddah, and who intend to fast Ramadan will be recruited over 2 months period prior to Ramadan. Those who accept and fulfill the inclusion criteria will be consented to participate. During Ramadan they will be requested to do home glucose monitoring which is part of standard of care and will also be put on glucose sensors for 14 days, after which reprots will be downloaded
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| Name | Affiliation | Role |
|---|---|---|
| Reem M Alamoudi | King Abdullah International Medical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KingAbullahIMRC | Jeddah | Saudi Arabia |
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| ID | Term |
|---|---|
| D011254 | Pregnancy in Diabetics |
| D016640 | Diabetes, Gestational |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |