NCT04862390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

April 25, 2021

Last Update Submit

January 3, 2022

Conditions

Pregnancy in Diabetic

Keywords

Pregnant, gestational diabetes, fasting

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Glucose variability during fasting Ramadan

    1 month

  • Number of days that needed to break fasting

    1 month

  • Time in range (TIR)

    1 month

  • Time above range (TAR)

    1 month

  • Time below range (TBR)

    1 month

Study Arms (3)

Normal Pregnancy

Pregnant women with no diabetes

Device: Continuous glucose monitoring

Gestational diabetes on diet alone

Device: Continuous glucose monitoring

Gestational diabetes on diet + Metformin therapy

Device: Continuous glucose monitoring

Interventions

Continuous glucose monitoringDEVICE

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

Gestational diabetes on diet + Metformin therapyGestational diabetes on diet aloneNormal Pregnancy

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • Age below18 years
  • Pregnant women with diabetes on insulin (type 1 and type 2 diabetes)
  • Renal and liver impairment.
  • Adrenal insufficiency
  • Psychiatric diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KingAbullahIMRC

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Pregnancy in DiabeticsDiabetes, GestationalFasting

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Reem M Alamoudi

    King Abdullah International Medical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2021

First Posted

April 28, 2021

Study Start

March 28, 2021

Primary Completion

June 27, 2021

Study Completion

August 1, 2021

Last Updated

January 4, 2022

Record last verified: 2022-01

Locations

SA(1)