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

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ClinicalTrials.gov Identifier: NCT04862390
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
King Abdullah International Medical Research Center

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.

Condition or disease Intervention/treatment
Pregnancy in Diabetic Device: Continuous glucose monitoring

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Hypoglycemia in Pregnant Women With or Without Diabetes During Fasting in Ramadan
Actual Study Start Date : March 28, 2021
Estimated Primary Completion Date : June 27, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Normal Pregnancy
Pregnant women with no diabetes
Device: Continuous glucose monitoring
Home continuous glucose monitoring to be installed for two weeks during fasting Ramadan

Gestational diabetes on diet alone Device: Continuous glucose monitoring
Home continuous glucose monitoring to be installed for two weeks during fasting Ramadan

Gestational diabetes on diet + Metformin therapy Device: Continuous glucose monitoring
Home continuous glucose monitoring to be installed for two weeks during fasting Ramadan




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862390


Contacts
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Contact: Reem M Alamoudi 0122266666 amoudir@ngha.med.sa

Locations
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Saudi Arabia
KingAbullahIMRC Recruiting
Jeddah, Saudi Arabia
Contact: Reem M Alamoudi    966505641595    amoudir@ngha.med.sa, refal2001@yahoo.com   
Sponsors and Collaborators
King Abdullah International Medical Research Center
Investigators
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Principal Investigator: Reem M Alamoudi King Abdullah International Medical Research Center
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Responsible Party: King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT04862390    
Other Study ID Numbers: NRJ21J/034/02
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King Abdullah International Medical Research Center:
Pregnant, gestational diabetes, fasting
Additional relevant MeSH terms:
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Pregnancy in Diabetics
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications