Type1diabetesRAMDAMNCT05747352
Safety of Closed-loop Hybrid Insulin Administration During Ramadan Fasting in People Living With Type 1 Diabetes
An observational study of Type1diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
Fasting in Ramadan is not recommended for people with type 1 diabetes. The main risk associated with fasting is dysglycemia (hypoglycemia, hyperglycemia, diabetic ketosis) and dehydration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1diabetes
- What is being tested?
- closed-loop hybrid insulin administration
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2023to 13 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Adult, Older adult
Study population: People with type 1 Diabetes
Who may be able to join
- age > 18 years
- type 1 diabetes for > 1 year
- on using closed-loop hybrid insulin administration
- scheduled Ramadan fasting
- patient put on using closed-loop hybrid insulin administration more than 2 months before the start of the Ramadan fast
- percentage of continuous glucose monitoring sensor wear > 70% in at least one of the two 30-day periods
Who cannot join
- patient put on using closed-loop hybrid insulin administration less than 2 months before the start of the Ramadan fast
- patient who is pregnant or wants to become pregnant immediately
- patient informed of the study who objected to the collection of his/her data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Glycemic Profile During the Ramadan Fasting in People With Type 1 Diabetes Treated With Closed-loop Hybrid Insulin System
Fasting in Ramadan is not recommended for people with type 1 diabetes. The main risk associated with fasting is dysglycemia (hypoglycemia, hyperglycemia, diabetic ketosis) and dehydration. Nevertheless, whether or not to practice Ramadan remains a personal choice and many people living with diabetes choose to perform this fast with or without their physician's approval. The purpose of this prospective observational study is to evaluate the safety and efficacy of an closed-loop hybrid insulin system on glycemic parameters and the level of hypoglycemia in patients with type 1 diabetes who wished to fast during Ramadan.
Read the detailed description
Primary objective: to evaluate the efficacy of an closed-loop hybrid insulin system on continuous glucose monitoring (CGM) glycemic parameters during the Ramadan fasting period Primary endpoint : to compare the time spent in the 3.9-10.0 mmol/l glucose target (TIR) from 30 days prior to the Ramadan fasting period to 30 days during the fasting period
- Conditions
- Type1diabetes
- Being tested
- closed-loop hybrid insulin administration
- Keywords
- type1diabetes, the Ramadan fasting period, closed-loop hybrid insulin administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed-loop hybrid insulin administrationOther
observational non-interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose time
time spent in the 3.9-10.0 mmol/l glucose target (TIR)) in the Ramadan period
Measured: Day 30
Secondary outcomes (3)
Glucose time
The time spent in the 3.9-10.0 mmol/l glucose target (TIR)) in 30 days prior the Ramadan period
Measured: Day 60
Glucose time
time spent below target 3.9 mmol/l
Measured: Day 30
Glucose time
time spent below target 2.97 mmol/l, between 2.97 and 3.79 mmol/l, between 9.05 mmol/l and 12.5mmol/l and > 12.5 mmol/l
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start5 Jun 2023
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dured DARDARI, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747352
- Sponsor's protocol ID
- 2023/0003
- Acronym
- RAMDAM
- Status last verified
- Nov 2023
- First submitted
- 17 Feb 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Outenah C, Ly Sall K, Penfornis A, Amadou C, Dardari D. Automated Insulin Delivery System: A Solution for Moderate to High-Risk Ramadan Fasting in People Living with Type 1 Diabetes. Diabetes Technol Ther. 2024 Nov;26(11):e881-e884. doi: 10.1089/dia.2024.0168. Epub 2024 Jul 17.
PubMed 38888435
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Glycemic Profile During the Ramadan Fasting in People With Type 1 Diabetes Treated With Closed-loop Hybrid Insulin System
- ClinicalTrials.gov ID
- NCT05747352
- Acronym / sponsor ID
- RAMDAM / 2023/0003
- Conditions
- Type1diabetes
- Keywords
- type1diabetes, the Ramadan fasting period, closed-loop hybrid insulin administration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 28 Feb 2023 (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.
Fasting in Ramadan is not recommended for people with type 1 diabetes. The main risk associated with fasting is dysglycemia (hypoglycemia, hyperglycemia, diabetic ketosis) and dehydration. Nevertheless, whether or not to practice Ramadan remains a personal choice and many people living with diabetes choose to perform this fast with or without their physician's approval. The purpose of this prospective observational study is to evaluate the safety and efficacy of an closed-loop hybrid insulin system on glycemic parameters and the level of hypoglycemia in patients with type 1 diabetes who wished to fast during Ramadan.
Detailed description
Primary objective: to evaluate the efficacy of an closed-loop hybrid insulin system on continuous glucose monitoring (CGM) glycemic parameters during the Ramadan fasting period Primary endpoint : to compare the time spent in the 3.9-10.0 mmol/l glucose target (TIR) from 30 days prior to the Ramadan fasting period to 30 days during the fasting period
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People with type 1 Diabetes
Key inclusion criteria (6 listed)
- age > 18 years
- type 1 diabetes for > 1 year
- on using closed-loop hybrid insulin administration
- scheduled Ramadan fasting
- patient put on using closed-loop hybrid insulin administration more than 2 months before the start of the Ramadan fast
Key exclusion criteria (3 listed)
- patient put on using closed-loop hybrid insulin administration less than 2 months before the start of the Ramadan fast
- patient who is pregnant or wants to become pregnant immediately
- patient informed of the study who objected to the collection of his/her data.
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 |
|---|---|---|
| closed-loop hybrid insulin administrationobservational non-interventional study | Other | – |
Primary outcome
Glucose time
Time frame: Day 30
time spent in the 3.9-10.0 mmol/l glucose target (TIR)) in the Ramadan period
3 secondary outcomes
Glucose time
Time frame: Day 60
Glucose time
Time frame: Day 30
Glucose time
Time frame: Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 38888435Outenah C, Ly Sall K, Penfornis A, Amadou C, Dardari D. Automated Insulin Delivery System: A Solution for Moderate to High-Risk Ramadan Fasting in People Living with Type 1 Diabetes. Diabetes Technol Ther. 2024 Nov;26(11):e881-e884. doi: 10.1089/dia.2024.0168. Epub 2024 Jul 17.
- Individual participant dataSharing planned: No
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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.
Dured DARDARI, MD principal investigator
Centre Hospitalier Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 7 Nov 2023. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glucose time (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05747352, which also lists 1 linked publication.
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 7 Nov 2023.