Pregnancy in DiabeticNCT04862390
Incidence of Hypoglycemia in Pregnant Ladies With or Without Gestational Diabetes Fasting Ramadan
An observational study of Pregnancy in Diabetic, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Pregnancy in Diabetic
- What is being tested?
- Continuous glucose monitoring
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 28 Mar 2021to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Adult
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
Who may be able to join
- 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.
Who cannot join
- Age below18 years
- Pregnant women with diabetes on insulin (type 1 and type 2 diabetes)
- Renal and liver impairment.
- Adrenal insufficiency
- Psychiatric diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy in Diabetic
- Being tested
- Continuous glucose monitoring
- Keywords
- Pregnant, gestational diabetes, fasting
- Medical subject headings
- Pregnancy in Diabetics, Diabetes, Gestational, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDevice
Home continuous glucose monitoring to be installed for two weeks during fasting Ramadan
| Study group | Role | What they receive |
|---|---|---|
| Normal Pregnancy | Pregnant women with no diabetes Receives: Device: Continuous glucose monitoring | |
| Gestational diabetes on diet alone | Not described Receives: Device: Continuous glucose monitoring | |
| Gestational diabetes on diet + Metformin therapy | Not described Receives: Device: Continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (5)
Glucose variability during fasting Ramadan
To estimate the difference in the groups in glucose variability
Measured: 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
Measured: 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.
Measured: 1 month
Time above range (TAR)
TAR that defined as blood glucose range >140 mg/dl (>7.8 mmol/L) according to ADA guideline.
Measured: 1 month
Time below range (TBR)
TBR that defined as blood glucose range < 60 mg/dl
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start28 Mar 2021
- Primary completion27 Jun 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy in DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reem M Alamoudi, Principal investigator, King Abdullah International Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862390
- Sponsor's protocol ID
- NRJ21J/034/02
- Status last verified
- Jan 2022
- First submitted
- 25 Apr 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Hypoglycemia in Pregnant Women With or Without Diabetes During Fasting in Ramadan
- ClinicalTrials.gov ID
- NCT04862390
- Acronym / sponsor ID
- NRJ21J/034/02
- Conditions
- Pregnancy in Diabetic
- Keywords
- Pregnant, gestational diabetes, fasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 28 Mar 2021 (actual)
- Primary completion
- 27 Jun 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Pregnancy | – | Device: Continuous glucose monitoringPregnant women with no diabetes |
| Gestational diabetes on diet alone | – | Device: Continuous glucose monitoring |
| Gestational diabetes on diet + Metformin therapy | – | Device: Continuous glucose monitoring |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Age below18 years
- Pregnant women with diabetes on insulin (type 1 and type 2 diabetes)
- Renal and liver impairment.
- Adrenal insufficiency
- Psychiatric diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitoringHome continuous glucose monitoring to be installed for two weeks during fasting Ramadan | Device | Gestational diabetes on diet + Metformin therapy, Gestational diabetes on diet alone, Normal Pregnancy |
Primary outcome
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
5 secondary outcomes
Glucose variability during fasting Ramadan
Time frame: 1 month
Number of days that needed to break fasting
Time frame: 1 month
Time in range (TIR)
Time frame: 1 month
Time above range (TAR)
Time frame: 1 month
Time below range (TBR)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reem M Alamoudi principal investigator
King Abdullah International Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy in Diabetic, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemia incidence with fasting (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.