Ramadan Flash Glucose Monitoring Study

NCT ID: NCT04356898

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

321 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-15

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetes fasting

Diabetes patients who decided to fast during the month of Ramadan

No intervention

Intervention Type OTHER

No intervention

Diabetes non-fasting

Diabetes patients who decided to not fast during the month of Ramadan

No intervention

Intervention Type OTHER

No intervention

Healthy

Healthy volunteers that decided to fast during the month of Ramadan

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diabetes, age\>=18

Exclusion Criteria

* pregnancy, renal failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London Diabetes Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nader Lessan, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College London Diabetes Center (ICLDC)

Locations

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Imperial College London Diabetes Centre

Abu Dhabi, , United Arab Emirates

Site Status

Imperial College London Diabetes Centre

Abu Dhabi, , United Arab Emirates

Site Status

Countries

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United Arab Emirates

Other Identifiers

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IREC042

Identifier Type: -

Identifier Source: org_study_id

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