Ramadan Flash Glucose Monitoring Study (RFGM)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 321

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi, United Arab Emirates, 48338
    • Imperial College London Diabetes Centre
  • Abu Dhabi, United Arab Emirates
    • Imperial College London Diabetes Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

• diabetes, age>=18

Exclusion Criteria:

• pregnancy, renal failure

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetes fasting; Diabetes patients who decided to fast during the month of Ramadan	Other: No intervention; No intervention
Diabetes non-fasting; Diabetes patients who decided to not fast during the month of Ramadan	Other: No intervention; No intervention
Healthy; Healthy volunteers that decided to fast during the month of Ramadan	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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).	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).	Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

Collaborators and Investigators

• Sponsor: Imperial College London Diabetes Centre
• Investigators: Principal Investigator: Nader Lessan, MD FRCP, Imperial College London Diabetes Center (ICLDC)

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: April 19, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Type 1 Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: IREC042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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