Clinical trial NCT04356898: Ramadan Flash Glucose Monitoring Study
Official title: Glucose Profiles in Ramadan-fasting Diabetes Patients: Ramadan Flash Glucose Monitoring (RFGM) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Type 1 Diabetes
Type 2 Diabetes
Lead sponsor: Imperial College London Diabetes Centre
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* diabetes, age\>=18

Exclusion Criteria:

* pregnancy, renal failure

Primary outcomes:
measure: Change in mean glucose level; (mmol/L)
timeFrame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
measure: Change in percentage of time in target blood glucose range (3.9 - 10.0 mmol/L); (%)
timeFrame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
measure: Coefficient of variance (CV); (coefficient; no units)
timeFrame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
measure: Area under the curve (AUC); ((mmol/L)*h)
timeFrame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Secondary outcomes:
measure: Change in glucose management indicator (GMI) ; (index; no units)
timeFrame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
measure: Change in percentage of time in level 1 (<3.9 - 10.0 mmol/L) hypoglycaemic range (mmol/L); (%)
timeFrame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
measure: Change in percentage of time in level 2 (<3.0 mmol/l) hypoglycaemic range (mmol/L); (%)
timeFrame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
measure: Change in percentage of time in level 1 (>10.0 mmol/L); (%)
timeFrame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
measure: Change in percentage of time in level 2 (>13.9 mmol/L); (%)
timeFrame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
measure: Standard deviation (SD); (SD (no units) of glucose mmol/L)
timeFrame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
measure: Low blood glucose index (LBGI)
timeFrame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
measure: High blood glucose index (HBGI)
timeFrame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Imperial College London Diabetes Centre
city: Abu Dhabi
country: United Arab Emirates
facility: Imperial College London Diabetes Centre
Study officials:
affiliation: Imperial College London Diabetes Center (ICLDC)
name: Nader Lessan, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References: