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

NCT ID: NCT04862390

Last Updated: 2022-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-28

Study Completion Date

2021-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy in Diabetic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal Pregnancy

Pregnant women with no diabetes

Continuous glucose monitoring

Intervention Type DEVICE

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

Gestational diabetes on diet alone

Continuous glucose monitoring

Intervention Type DEVICE

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

Gestational diabetes on diet + Metformin therapy

Continuous glucose monitoring

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Continuous glucose monitoring

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King Abdullah International Medical Research Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Reem M Alamoudi

Role: PRINCIPAL_INVESTIGATOR

King Abdullah International Medical Research Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

KingAbullahIMRC

Jeddah, , Saudi Arabia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Saudi Arabia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NRJ21J/034/02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gestational Diabetes Monitoring and Management
NCT06963528 ACTIVE_NOT_RECRUITING