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Completed

NCT Number: NCT04356898

Ramadan Flash Glucose Monitoring 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.

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Key information

Conditions

Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diabetes, age>=18

Exclusion criteria

  • pregnancy, renal failure

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Secondary outcomes

  1. Change in glucose management indicator (GMI) ; (index; no units)

    Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

    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).

  2. 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)

    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).

  3. 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)

    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).

  4. 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)

    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).

  5. 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)

    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).

  6. Standard deviation (SD); (SD (no units) of glucose mmol/L)

    Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

    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).

  7. Low blood glucose index (LBGI)

    Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

    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).

  8. High blood glucose index (HBGI)

    Time frame: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

    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).

Sponsors and collaborators

Lead sponsor

Imperial College London Diabetes Centre

Other

Registry information

Official study title

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

Acronym: RFGM

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2020
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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