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IRCT20260429069208N1 IRCT 2026-09-26 Mashhad University of Medical Sciences The effect of Ramadan fasting on diabetic patients 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) 2026-09-23 anticipated 21 Recruiting https://irct.ir/trial/89843 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. N/A Type 2 diabetes. 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.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Not yet decided.
public Samaneh Abolbashari
Department of Internal Medicine, Second Floor, Ghaem Hospital, Ahmad Abad Boulvard
Mashhad Iran (Islamic Republic of) 99199-91766 +98 915 118 7681 abolbasharism@mums.ac.ir Mashhad University of Medical Sciences scientific Zahra Mazloim Khorasani
Department of Internal Medicine, Second Floor, Ghaem Hospital, AhmadAbad Boulvard
Mashhad Iran (Islamic Republic of) 99199-91766 +98 915 109 8005 mazloumz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 18 years 70 years Both 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 E11.9 Type 2 diabetes mellitus without complications Lifestyle 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. 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. Weight. Timepoint: During fasting and 2 months after the end of Ramadan. Method of measurement: Beurer Glass Scale, GS 206. Blood pressure. Timepoint: During fasting and 2 months after the end of Ramadan. Method of measurement: Blood pressure gauge. Average fasting blood sugar. Timepoint: During fasting and 2 months after the end of Ramadan. Method of measurement: Continuous Glucose Monitoring (CGM) device. Mashhad University of Medical Sciences Approved 2025-10-07 Mashhad University of Medical Sciences Ethics committee Vice-Presidency for Research and Technology, 4th Floor, Dr. Shahid Khwarazmi Educational Complex, University Campus, Eastern Gate of Ferdowsi University of Mashhad, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)