Diabetes MellitusRFGMNCT04356898

Ramadan Flash Glucose Monitoring Study

An observational study of Diabetes Mellitus, run by Imperial College London Diabetes Centre at 2 sites in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Many Muslim patients with diabetes observe dawn to sunset fasting during the month of Ramadan. Hyperglycaemia and hypoglycaemia are possible problems amongst these patients. The aim of this study is to investigate glucose profiles in diabetes and non-diabetes patients that decided to fast or not to fast during Ramadan. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes Mellitus
How many people: 321 participants
Where: 2 sitesUnited Arab Emirates
Study dates: 15 Apr 2018to 31 Dec 2019
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 65 years
All sexes
Adult, Older adult

Study population: Primary care clinic

Who may be able to join

diabetes, age>=18

Who cannot join

pregnancy, renal failure

Trial locations and contacts

2 sites in 1 country.

United Arab Emirates2 sites

Imperial College London Diabetes Centre
Abu Dhabi, 48338
Imperial College London Diabetes Centre
Abu Dhabi

Other trials in United Arab Emirates

About this study

Official title: Glucose Profiles in Ramadan-fasting Diabetes Patients: Ramadan Flash Glucose Monitoring (RFGM) Study

Read the detailed description

A good knowledge of the profiles of blood glucose with different treatments can help in making Ramadan fasting free of unwanted effects for such patients. Previous studies, including the EPIDIAR have shown an increased risk of hypo- and hyperglycaemia in patients with diabetes who fast during the Holy month of Ramadan.Although self-monitoring of blood glucose (SMBG) is useful in fasting diabetes patients when used within a structured testing regimen, it requires a lot of effort and compliance from the patient and doesn't provide continuous blood glucose data. The amount of data provided using SMBG depends on the frequency of finger pricks measurements. Flash Glucose Monitoring (FGM) sensors provide a record of the individual's glucose levels, trends and patterns for up to 14 days. This sensor doesn't require calibration using finger pricks. FGM data show how day-to-day decisions and behaviours impact the control of blood sugar levels. Availability of FGM makes it possible to explore glucose profiles in a continuous fashion during Ramadan period and make comparisons with non-fasting times outside Ramadan. The aim of this study is to investigate glucose profiles in diabetes and non-diabetes patients that decided to fast or not to fast during Ramadan. The study will compare several parameters extracted from the FGM trace such us the incident of hypoglycaemia and hyperglycaemia, standard deviation, coefficient of variance and time in/above/below range. For this purpose the FreeStyle Libre sensor will be used. Patients will be asked to use the FreeStyle Libre sensor for a period of 3 months: 1 month before Ramadan, during Ramadan and one month after Ramadan.

Conditions: Diabetes Mellitus
Being tested: No intervention
Keywords: Type 1 Diabetes, Type 2 Diabetes
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionOther
No intervention

Study groups in NCT04356898
Study group	Role	What they receive
Diabetes fasting		Diabetes patients who decided to fast during the month of Ramadan Receives: Other: No intervention
Diabetes non-fasting		Diabetes patients who decided to not fast during the month of Ramadan Receives: Other: No intervention
Healthy		Healthy volunteers that decided to fast during the month of Ramadan Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in mean glucose level; (mmol/L)
This primary outcome is aimed at measurement of change in mean glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Measured: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Change in percentage of time in target blood glucose range (3.9 - 10.0 mmol/L); (%)
This primary outcome is aimed at measurement of change in percentage of time in target blood glucose range,in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Measured: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Coefficient of variance (CV); (coefficient; no units)
This primary outcome is aimed at measurement of coefficient of variance of blood glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Measured: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Area under the curve (AUC); ((mmol/L)*h)
This primary outcome is aimed at measurement of area under the curve for blood glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Measured: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

Secondary outcomes (8)

Change in glucose management indicator (GMI) ; (index; no units)
This primary outcome is aimed at measurement of change in glucose management indicator (GMI) for blood glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Measured: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Change in percentage of time in level 1 (<3.9 - 10.0 mmol/L) hypoglycaemic range (mmol/L); (%)
This primary outcome is aimed at measurement of change in percentage of time in level 1 hypoglycaemic range, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Measured: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Change in percentage of time in level 2 (<3.0 mmol/l) hypoglycaemic range (mmol/L); (%)
This primary outcome is aimed at measurement of change in percentage of time in level 1 hypoglycaemic range, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Measured: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Change in percentage of time in level 1 (>10.0 mmol/L); (%)
This primary outcome is aimed at measurement of change in percentage of time in level 1 hyperglycaemic range, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Measured: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Change in percentage of time in level 2 (>13.9 mmol/L); (%)
This primary outcome is aimed at measurement of change in percentage of time in level 1 hyperglycaemic range, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Measured: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Standard deviation (SD); (SD (no units) of glucose mmol/L)
This primary outcome is aimed at measurement of standard deviation of blood glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Measured: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Low blood glucose index (LBGI)
This primary outcome is aimed at measurement of low blood glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Measured: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
High blood glucose index (HBGI)
This primary outcome is aimed at measurement of high blood glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Measured: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 201831 Dec 2019

First posted22 Apr 2020
Study start15 Apr 2018
Primary completion31 Mar 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes MellitusStudies 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: 321 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04356898
Sponsor's protocol ID: IREC042
Acronym: RFGM
Status last verified: Oct 2018
First submitted: 18 Oct 2018
Last updated: 24 Apr 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Glucose Profiles in Ramadan-fasting Diabetes Patients: Ramadan Flash Glucose Monitoring (RFGM) Study
ClinicalTrials.gov ID: NCT04356898
Acronym / sponsor ID: RFGM / IREC042
Conditions: Diabetes Mellitus
Keywords: Type 1 Diabetes, Type 2 Diabetes
Study type: Observational
Recruitment status: Completed
Enrolment: 321 participants (actual)
Lead sponsor: Imperial College London Diabetes CentreUniversity, hospital or other
Study start: 15 Apr 2018 (actual)
Primary completion: 31 Mar 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 22 Apr 2020 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Diabetes fasting	–	Other: No interventionDiabetes patients who decided to fast during the month of Ramadan
Diabetes non-fasting	–	Other: No interventionDiabetes patients who decided to not fast during the month of Ramadan
Healthy	–	Other: No interventionHealthy volunteers that decided to fast during the month of Ramadan

Who may qualify

Ages: 18 to 65 years
Sex: All
Age groups: Adult, Older adult
Study population: Primary care clinic

Key inclusion criteria (1 listed)

diabetes, age>=18

Key exclusion criteria (1 listed)

pregnancy, renal failure

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
No interventionNo intervention	Other	Diabetes fasting, Diabetes non-fasting, Healthy

Primary outcome

Change in mean glucose level; (mmol/L)
Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
This primary outcome is aimed at measurement of change in mean glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Change in percentage of time in target blood glucose range (3.9 - 10.0 mmol/L); (%)
Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
This primary outcome is aimed at measurement of change in percentage of time in target blood glucose range,in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Coefficient of variance (CV); (coefficient; no units)
Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
This primary outcome is aimed at measurement of coefficient of variance of blood glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Area under the curve (AUC); ((mmol/L)*h)
Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
This primary outcome is aimed at measurement of area under the curve for blood glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).

8 secondary outcomes

Change in glucose management indicator (GMI) ; (index; no units)
Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Change in percentage of time in level 1 (<3.9 - 10.0 mmol/L) hypoglycaemic range (mmol/L); (%)
Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Change in percentage of time in level 2 (<3.0 mmol/l) hypoglycaemic range (mmol/L); (%)
Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Change in percentage of time in level 1 (>10.0 mmol/L); (%)
Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Change in percentage of time in level 2 (>13.9 mmol/L); (%)
Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Standard deviation (SD); (SD (no units) of glucose mmol/L)
Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Low blood glucose index (LBGI)
Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
High blood glucose index (HBGI)
Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

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 24 Apr 2020.
Individual participant dataSharing planned: No

Related trials for Diabetes Mellitus

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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.

Nader Lessan, MD FRCP principal investigator

Imperial College London Diabetes Center (ICLDC)

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, run by Imperial College London Diabetes Centre at 2 sites in United Arab Emirates.

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 1 inclusion and 1 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 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Arab Emirates. 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?

Change in mean glucose level; (mmol/L) (time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04356898.

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 24 Apr 2020.