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Completed

NCT Number: NCT04862390

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

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.

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Key information

Conditions

Pregnancy in Diabetic Behavior Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Fasting Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Pregnancy in Diabetics Urogenital Diseases

Age range

18 year–48 year

Sex eligibility

Female

Study type

Observational

Primary location

KingAbullahIMRC

Jeddah, Saudi Arabia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous glucose monitoring

Device

Home continuous glucose monitoring to be installed for two weeks during fasting Ramadan

Primary outcomes

  1. Hypoglycemia incidence with fasting

    Time frame: 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 outcomes

  1. Glucose variability during fasting Ramadan

    Time frame: 1 month

    To estimate the difference in the groups in glucose variability

  2. Number of days that needed to break fasting

    Time frame: 1 month

    To estimate the difference in the groups in number of days that needed to break fasting

  3. Time in range (TIR)

    Time frame: 1 month

    TIR is defined as blood glucose range between 63-140 mg/dl (3.5-7.8 mmol/L) according to ADA guideline.

  4. Time above range (TAR)

    Time frame: 1 month

    TAR that defined as blood glucose range >140 mg/dl (>7.8 mmol/L) according to ADA guideline.

  5. Time below range (TBR)

    Time frame: 1 month

    TBR that defined as blood glucose range < 60 mg/dl

Sponsors and collaborators

Lead sponsor

King Abdullah International Medical Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2021
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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