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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy in Diabetic
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia
    • KingAbullahIMRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2021
• Primary Completion (Actual): June 27, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: April 25, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Pregnant, gestational diabetes, fasting
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Pregnancy Complications; Hypoglycemia; Pregnancy in Diabetics
• Other Study ID Numbers: NRJ21J/034/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No