Ramadan Flash Glucose Monitoring Study

Diabetes Mellitus Clinical Trial

— RFGM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356898
• Other study ID #: IREC042
• Status: Completed
• Start date: April 15, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2018
• Source: Imperial College London Diabetes Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: December 31, 2019
• Est. primary completion date: March 31, 2019
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• diabetes, age>=18

Exclusion Criteria:

• pregnancy, renal failure

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
United Arab Emirates	Imperial College London Diabetes Centre	Abu Dhabi
United Arab Emirates	Imperial College London Diabetes Centre	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London Diabetes Centre

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)