Diabetes Mellitus, Type 2 Treated With InsulinEarly Phase 1NCT06826547
Optimization of Basal Insulin During Ramadan Fasting in Type 2 Diabetic Patients: Comparison Between DAR Recommendations and the Carbohydrate Fasting Test & Metabolic and Inflammatory Consequences
A Early Phase 1 study testing Adjustment of insulin doses DAR and Adjustment of insulin doses CFT in people with Diabetes Mellitus, Type 2 Treated With Insulin and Fasting, Intermittent, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Ramadan, a fasting period observed by many Muslim patients, poses a significant challenge for glycemic management in diabetics. During this month, abstinence from food, water, and medication from dawn to dusk leads to significant glycemic fluctuations. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2 Treated With Insulin, Fasting, Intermittent, Ramadan Fasting
- What is being tested?
- Adjustment of insulin doses DAR and Adjustment of insulin doses CFT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Feb 2025to 30 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 70 years with Type 2 diabetes on a basal insulin regimen (NPH, Detemir, or Glargine) with or without 1 to 2 boluses of rapid-acting insulin.
- Diabetes duration of at least 2 years and insulin therapy for at least 6 months.
- Patients wishing to fast during Ramadan and having provided informed consent.
- Low risk of complications according to the IDF-DAR 2021 risk score or moderate risk for patients who insist on fasting.
- Non-Inclusion Criteria:
- High-risk patients according to IDF-DAR 2021 score >6, including those with:
Show all 13Show fewer
- Severe renal impairment
- Cognitive dysfunction or frailty
- Unrecognized hypoglycemia
- Unstable cardiovascular disease
- Pregnancy
- Type 1 diabetes
- Type 2 diabetes patients on sulfonylureas or related medications
Who cannot join
- Patients who did not follow the study protocol regarding insulin dose adjustments and capillary blood glucose (CBG) self-monitoring.
- Fasting discontinuation without medical advice.
- Severe complications requiring fasting cessation.
- Patients who withdrew their informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Ramadan, a fasting period observed by many Muslim patients, poses a significant challenge for glycemic management in diabetics. During this month, abstinence from food, water, and medication from dawn to dusk leads to significant glycemic fluctuations. Inadequate insulin dose management can cause acute complications such as hypoglycemia, hyperglycemia, ketosis, or hyperosmolar states. In 2021, the Diabetes and Ramadan (DAR) guidelines provided recommendations for adjusting insulin doses, taking into account changes in circadian rhythms and patients' dietary habits. However, these standardized recommendations may not be suitable for everyone. A personalized alternative, the Carbohydrate Fasting Test (CFT), allows for the assessment of individual basal insulin needs through a controlled fast excluding carbohydrates for 24 hours. Comparing these two approaches could provide valuable insights into their relative effectiveness, particularly in terms of safety and quality of life for patients.
Moreover, diabetes can be influenced by fasting, with potentially beneficial effects on inflammation and metabolism.
Read more
This study aims to determine which of these two methods optimizes glycemic control and to assess the variations of inflammation markers before and after Ramadan fasting. The results could be integrated into future clinical practices to improve diabetes management during Ramadan. We aim to compare the effectiveness and safety of basal insulin dose adjustments according to DAR 2021 guidelines versus the Carbohydrate Fasting Test (CFT) and to analyze the impact on the quality of life of diabetic patients. This is a prospective, longitudinal, randomized, interventional study including 60 Type 2 diabetic patients, aged 18 to 70 years old, on insulin therapy for at least 6 months. All participants intend to fast during Ramadan and are at low to moderate risk according to the IDF-DAR score (≤6).
Eligible patients will be randomly assigned into two groups:
DAR Group: Insulin dose adjustments according to DAR 2021 recommendations. CFT Group: Personalized insulin adjustments based on a Carbohydrate Fasting Test conducted before Ramadan.
Protocol:
Initial assessment will be Clinical ( Weight, BMI, blood pressure) and biological (Fasting glucose, HbA1c, fructosamine and inflammatory markers ( Interleukin 6 and TNF alfa)).
During Ramadan, weekly glycemic monitoring will be conducted to track blood sugar levels. Any complications will be recorded, and insulin dose adjustments will be made remotely if necessary to ensure optimal glycemic control.
In the last week of Ramadan, a final clinical assessment will be performed, including measurements of weight, BMI, and blood pressure. A biological assessment will also be conducted to measure fructosamine levels and inflammatory markers ( Interleukin 6 and TNF alfa).
Two months after Ramadan, fasting glucose and HbA1c levels will be re-evaluated to assess long-term glycemic control. The study will also analyze the impact on glycemic regulation, anthropometric parameters, and overall quality of life using the SF-12 questionnaire.
In conclusion, this project aims to identify the most effective method for adjusting basal insulin doses during Ramadan, contributing to optimal Type 2 diabetes management and to assess the variations of inflammation markers before and after Ramadan fasting.
- Conditions
- Diabetes Mellitus, Type 2 Treated With Insulin, Fasting, Intermittent, Ramadan Fasting, Inflammatory Markers
- Being tested
- Adjustment of insulin doses DAR, Adjustment of insulin doses CFT
- Medical subject headings
- Diabetes Mellitus, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustment of insulin doses DARDrug
Patients will be hospitalized at La Rabta Hospital from February 15 to February 28, 2025 for clinical (weight, BP, SF-12), biological (HbA1c, lipid profile) assessments and inflammatory markers (Interleukin 6 and TNF alfa) DAR Group: Insulin will be adjusted per DAR 2021 guidelines. Patients will track insulin doses, glycemic cycles, hypoglycemia episodes, fasting interruptions, and hospital visits in a dedicated log. They will receive weekly calls for insulin adjustments and continuous support.
During the last week of Ramadan, clinical and biological data including inflammatory markers will be collected. Two months post-Ramadan, HbA1c, fasting glucose, and lipid profile will be reassessed to evaluate glycemic control.
Adjustment of insulin doses CFTDrug
Patients will be hospitalized at La Rabta Hospital from February 15 to February 28, 2025 for clinical (weight, BP, SF-12) and biological (HbA1c, lipid profile) assessments and inflammatory markers (Interleukin 6 and TNF alfa) .
CFT Group: Insulin adjusted after a Carbohydrate Fasting Test. Patients will track insulin doses, glycemic cycles, hypoglycemia episodes, fasting interruptions, and hospital visits in a dedicated log. They will receive weekly calls for insulin adjustments and continuous support.
During the last week of Ramadan, clinical and biological data including inflammatory markers will be collected. Two months post-Ramadan, HbA1c, fasting glucose, and lipid profile will be reassessed to evaluate glycemic control.
| Study group | Role | What they receive |
|---|---|---|
| DAR Group | Active comparator | The basal insulin doses will be adjusted in accordance with the recommendations published by DAR in 2021 for diabetic patients during Ramadan. Receives: Drug: Adjustment of insulin doses DAR |
| CFT Group | Active comparator | The basal insulin doses will be adjusted after a carbohydrate fasting test to assess individual insulin needs during fasting periods. Receives: Drug: Adjustment of insulin doses CFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
fructosamine levels
Fructosamine variation 15 days before \& the last week of Ramadan
Measured: up to 6 weeks
Interleukin-6 levels
variation during the fast of Ramadan 15 dayd before and at the Last week of Ramadan
Measured: up to 6 weeks
Hypoglycemia
Frequency of hypoglycemic episodes
Measured: up to one month
glycemic auto-monitoring
Percentage of blood glucose values meeting target levels during the month of Ramadan
Measured: up to one month
HbA1c levels
HbA1c variation before and after Ramadan 15 days before \& 2 months after Ramadan
Measured: up to 6 weeks
TNF-alfa levels
Variation during fasting Ramadan 15 days before and at the Last week of Ramadan
Measured: up to 6 weeks
Secondary outcomes (4)
Body mass index
Body mass index variation : Before and at the Last week of Ramadan
Measured: up to 6 weeks
Quality of life of patients
Quality of life of patients assessed using the Medical Outcomes Study Short-Form General Health Survey (SF-12) questionnaire in its validated Tunisian dialect version.
Before and at at the last week of Ramadan Higher score means a better quality of life.
Measured: up to 6 weeks
waist circumference
variation of waist circumference: Before and at the Last week of Ramadan
Measured: up to 6 weeks
Blood pressure
Variation of blood pressure : Before and at the Last week of Ramadan
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start15 Feb 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2 Treated With InsulinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital La Rabta
- Responsible party
- Principal investigator, Chayma Bel Hadj Sliman, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826547
- Sponsor's protocol ID
- RE001
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Basal Insulin During Ramadan Fasting in Type 2 Diabetic Patients: Comparison Between DAR Recommendations and the Carbohydrate Fasting Test & Metabolic and Inflammatory Consequences
- ClinicalTrials.gov ID
- NCT06826547
- Acronym / sponsor ID
- RE001
- Conditions
- Diabetes Mellitus, Type 2 Treated With Insulin, Fasting, Intermittent, Ramadan Fasting, Inflammatory Markers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Collaborators
- Hopital La Rabta
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ramadan, a fasting period observed by many Muslim patients, poses a significant challenge for glycemic management in diabetics. During this month, abstinence from food, water, and medication from dawn to dusk leads to significant glycemic fluctuations. Inadequate insulin dose management can cause acute complications such as hypoglycemia, hyperglycemia, ketosis, or hyperosmolar states. In 2021, the Diabetes and Ramadan (DAR) guidelines provided recommendations for adjusting insulin doses, taking into account changes in circadian rhythms and patients' dietary habits. However, these standardized recommendations may not be suitable for everyone. A personalized alternative, the Carbohydrate Fasting Test (CFT), allows for the assessment of individual basal insulin needs through a controlled fast excluding carbohydrates for 24 hours. Comparing these two approaches could provide valuable insights into their relative effectiveness, particularly in terms of safety and quality of life for patients.
Moreover, diabetes can be influenced by fasting, with potentially beneficial effects on inflammation and metabolism.
This study aims to determine which of these two methods optimizes glycemic control and to assess the variations of inflammation markers before and after Ramadan fasting. The results could be integrated into future clinical practices to improve diabetes management during Ramadan. We aim to compare the effectiveness and safety of basal insulin dose adjustments according to DAR 2021 guidelines versus the Carbohydrate Fasting Test (CFT) and to analyze the impact on the quality of life of diabetic patients. This is a prospective, longitudinal, randomized, interventional study including 60 Type 2 diabetic patients, aged 18 to 70 years old, on insulin therapy for at least 6 months. All participants intend to fast during Ramadan and are at low to moderate risk according to the IDF-DAR score (≤6).
Eligible patients will be randomly assigned into two groups:
DAR Group: Insulin dose adjustments according to DAR 2021 recommendations. CFT Group: Personalized insulin adjustments based on a Carbohydrate Fasting Test conducted before Ramadan.
Protocol:
Initial assessment will be Clinical ( Weight, BMI, blood pressure) and biological (Fasting glucose, HbA1c, fructosamine and inflammatory markers ( Interleukin 6 and TNF alfa)).
During Ramadan, weekly glycemic monitoring will be conducted to track blood sugar levels. Any complications will be recorded, and insulin dose adjustments will be made remotely if necessary to ensure optimal glycemic control.
In the last week of Ramadan, a final clinical assessment will be performed, including measurements of weight, BMI, and blood pressure. A biological assessment will also be conducted to measure fructosamine levels and inflammatory markers ( Interleukin 6 and TNF alfa).
Two months after Ramadan, fasting glucose and HbA1c levels will be re-evaluated to assess long-term glycemic control. The study will also analyze the impact on glycemic regulation, anthropometric parameters, and overall quality of life using the SF-12 questionnaire.
In conclusion, this project aims to identify the most effective method for adjusting basal insulin doses during Ramadan, contributing to optimal Type 2 diabetes management and to assess the variations of inflammation markers before and after Ramadan fasting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAR Group | Active comparator | Drug: Adjustment of insulin doses DARThe basal insulin doses will be adjusted in accordance with the recommendations published by DAR in 2021 for diabetic patients during Ramadan. |
| CFT Group | Active comparator | Drug: Adjustment of insulin doses CFTThe basal insulin doses will be adjusted after a carbohydrate fasting test to assess individual insulin needs during fasting periods. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults aged 18 to 70 years with Type 2 diabetes on a basal insulin regimen (NPH, Detemir, or Glargine) with or without 1 to 2 boluses of rapid-acting insulin.
- Diabetes duration of at least 2 years and insulin therapy for at least 6 months.
- Patients wishing to fast during Ramadan and having provided informed consent.
- Low risk of complications according to the IDF-DAR 2021 risk score or moderate risk for patients who insist on fasting.
- High-risk patients according to IDF-DAR 2021 score >6, including those with:
Key exclusion criteria (4 listed)
- Patients who did not follow the study protocol regarding insulin dose adjustments and capillary blood glucose (CBG) self-monitoring.
- Fasting discontinuation without medical advice.
- Severe complications requiring fasting cessation.
- Patients who withdrew their informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjustment of insulin doses DARPatients will be hospitalized at La Rabta Hospital from February 15 to February 28, 2025 for clinical (weight, BP, SF-12), biological (HbA1c, lipid profile) assessments and inflammatory markers (Interleukin 6 and TNF alfa) DAR Group: Insulin will be adjusted per DAR 2021 guidelines. Patients will track insulin doses, glycemic cycles, hypoglycemia episodes, fasting interruptions, and hospital visits in a dedicated log. They will receive weekly calls for insulin adjustments and continuous support. During the last week of Ramadan, clinical and biological data including inflammatory markers will be collected. Two months post-Ramadan, HbA1c, fasting glucose, and lipid profile will be reassessed to evaluate glycemic control. | Drug | DAR Group |
| Adjustment of insulin doses CFTPatients will be hospitalized at La Rabta Hospital from February 15 to February 28, 2025 for clinical (weight, BP, SF-12) and biological (HbA1c, lipid profile) assessments and inflammatory markers (Interleukin 6 and TNF alfa) . CFT Group: Insulin adjusted after a Carbohydrate Fasting Test. Patients will track insulin doses, glycemic cycles, hypoglycemia episodes, fasting interruptions, and hospital visits in a dedicated log. They will receive weekly calls for insulin adjustments and continuous support. During the last week of Ramadan, clinical and biological data including inflammatory markers will be collected. Two months post-Ramadan, HbA1c, fasting glucose, and lipid profile will be reassessed to evaluate glycemic control. | Drug | CFT Group |
Primary outcome
fructosamine levels
Time frame: up to 6 weeks
Fructosamine variation 15 days before \& the last week of Ramadan
Interleukin-6 levels
Time frame: up to 6 weeks
variation during the fast of Ramadan 15 dayd before and at the Last week of Ramadan
Hypoglycemia
Time frame: up to one month
Frequency of hypoglycemic episodes
glycemic auto-monitoring
Time frame: up to one month
Percentage of blood glucose values meeting target levels during the month of Ramadan
HbA1c levels
Time frame: up to 6 weeks
HbA1c variation before and after Ramadan 15 days before \& 2 months after Ramadan
TNF-alfa levels
Time frame: up to 6 weeks
Variation during fasting Ramadan 15 days before and at the Last week of Ramadan
4 secondary outcomes
Body mass index
Time frame: up to 6 weeks
Quality of life of patients
Time frame: up to 6 weeks
waist circumference
Time frame: up to 6 weeks
Blood pressure
Time frame: up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Adjustment of insulin doses DAR and Adjustment of insulin doses CFT in people with Diabetes Mellitus, Type 2 Treated With Insulin and Fasting, Intermittent, run by University Tunis El Manar at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fructosamine levels (time frame: up to 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.