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Evaluation of the effect of Ramadan fasting on the clinical and laboratory factors of type 2 diabetic patients treated with Insulin or Insulin secretory drugs by means of Continuous Glucose Monitoring (CGM)

Protocol summary

Study aim
Determining the effect of fasting during Ramadan on clinical and laboratory factors in type 2 diabetic patients treated with insulin or insulin secretagogues
Design
A non-randomized clinical trial without control group and without blinding, involving 21 patients.
Settings and conduct
Patients visiting the adult endocrinologist's office in Mashhad prior to the start of Ramadan who wish to fast during the month will be enrolled in the study. Participants will fast under medical supervision, and their blood glucose fluctuations during the fast will be measured and recorded over a 14-day period. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1. Diagnosis of type 2 diabetes 2. Age of 18 to 65 years 3. Access to a smartphone capable of running the application associated with the CGM device 4. Under treatment with Insulin or Insulin secretagogues 5. Willingness to fast for at least 14 days during Ramadan 6. Successful experience fasting in previous years Exclusion Criteria: 1. Change in the patient's risk score resulting in classification within the "contraindicated for fasting" group 2. Discontinuation of fasting by the patient 3. Patient's withdrawal of consent to continue participating in the study
Intervention groups
This study involves only one intervention group with no control group. The only intervention will be fasting during Ramadan, which will be undertaken based on the patients' own preference. Fluctuations in the participants' blood glucose levels will be recorded throughout the 14 days of fasting.
Main outcome variables
Blood sugar fluctuations during fasting and two months after the end of fasting by CGM, Changes in insulin dose and timing during fasting, Weight, Systolic and diastolic blood pressure, Average fasting blood sugar, Average postprandial blood sugar, HBA1C, Triglycerides, Cholesterol, LDL, HDL, Creatinine, GFR

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260429069208N1
Registration date: 2026-09-26, 1405/07/04
Registration timing: registered_while_recruiting

Last update: 2026-09-26, 1405/07/04
Update count: 0
Registration date
2026-09-26, 1405/07/04
Registrant information
Name
Samaneh Abolbashari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 2643
Email address
abolbasharism@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-23, 1405/07/01
Expected recruitment end date
2027-02-19, 1405/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Ramadan fasting on the clinical and laboratory factors of type 2 diabetic patients treated with Insulin or Insulin secretory drugs by means of Continuous Glucose Monitoring (CGM)
Public title
The effect of Ramadan fasting on diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes Age: 18 to 65 years Access to a smartphone that can be used to install the software related to the CGM device Under treatment with insulin or insulin secretagogues Intention to fast for at least 14 days during Ramadan Successful fasting experience in previous years
Exclusion criteria:
Change in patient's risk score and placement in the fasting prohibition group Discontinuing of fasting Patient not consenting to continue participating in the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 21
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences Ethics committee
Street address
Vice-Presidency for Research and Technology, 4th Floor, Dr. Shahid Khwarazmi Educational Complex, University Campus, Eastern Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2025-10-07, 1404/07/15
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1404.398

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications

Primary outcomes

1

Description
Fluctuations of Blood Glucose
Timepoint
Checking Blood Glucose fluctuations every 15 minutes for 14 days during fasting in Ramadan and then for 14 days, two months after the end of Ramadan.
Method of measurement
The amount of Glucose in the interstitial fluid is measured and recorded by a CGM device.

Secondary outcomes

1

Description
Weight
Timepoint
During fasting and 2 months after the end of Ramadan
Method of measurement
Beurer Glass Scale, GS 206

2

Description
Blood pressure
Timepoint
During fasting and 2 months after the end of Ramadan
Method of measurement
Blood pressure gauge

3

Description
Average fasting blood sugar
Timepoint
During fasting and 2 months after the end of Ramadan
Method of measurement
Continuous Glucose Monitoring (CGM) device

Intervention groups

1

Description
Intervention group: This study involves a single intervention group. Participants in this group will voluntarily fast during the month of Ramadan. No other intervention will be administered. Blood glucose fluctuations will be measured and recorded over a 14-day period using a Continuous Glucose Monitoring (CGM) device. We will use the Sibionics CGM device, purchased from Farir Asa Teb Company.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Adult Endocrinologist's Office
Full name of responsible person
Zahra Mazloum Khorasani
Street address
Abshar building, Moallem Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9178656553
Phone
+98 915 109 8005
Email
mazloumz@mums.ac.ir
Web page address
https://dr-mazloumkh.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Vice-Presidency for Research and Technology, 4th Floor, Dr. Shahid Khwarazmi Educational Complex, University Campus, Eastern Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3142 8801
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samaneh Abolbashari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Department of Internal Medicine, Second Floor, Ghaem Hospital, Ahmad Abad Boulvard
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 915 118 7681
Email
abolbasharism@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Mazloim Khorasani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinologist
Street address
Department of Internal Medicine, Second Floor, Ghaem Hospital, AhmadAbad Boulvard
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 915 109 8005
Email
mazloumz@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samaneh Abolbashari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3881 2643
Email
abolbasharism@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The project proposal, the results of the data analysis, and the informed consent form, if necessary, will be available for sharing with other researchers.
When the data will become available and for how long
From March 2027
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
N/A.
From where data/document is obtainable
By sending email to abolbasharism@mums.ac.ir
What processes are involved for a request to access data/document
The data will be sent via email upon approval by the principal investigator.
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