Ramadan Flash Glucose Monitoring Study (RFGM)

I

Imperial College London Diabetes Centre

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04356898
IREC042

Details and patient eligibility

About

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.

Full 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.

Enrollment

321 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

diabetes, age>=18

Exclusion criteria

pregnancy, renal failure

Trial design

321 participants in 3 patient groups

Diabetes fasting
Description:
Diabetes patients who decided to fast during the month of Ramadan
Treatment:
Other: No intervention
Diabetes non-fasting
Description:
Diabetes patients who decided to not fast during the month of Ramadan
Treatment:
Other: No intervention
Healthy
Description:
Healthy volunteers that decided to fast during the month of Ramadan
Treatment:
Other: No intervention

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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