MarathonMARADIABNCT04926298
Glycemic Control Before, During and After the 2016 Paris Marathon
An observational study of Marathon and Physical Activity, run by University Hospital, Brest at 1 site in France.
Trial summary
This is an observational mono-centric retrospective study carried out at the University Hospital of Brest The main objective of this study is to assess the glycemic control before, during and after the 2016 Paris Marathon in patients with type 1 diabetes using continuous glucose measurement (CGM) by DEXCOM sensor. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Marathon, Physical Activity, Type 1 Diabetes Mellitus
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 15 Aug 2020to 6 Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The therapeutic education structure of the diabetes department of the University Hospital of Brest received numerous requests from patients with type 1 diabetes for the individual tailoring of insulin and carbohydrates intake to participate in extreme sports events such as a marathon. A group of patients wished to carry out the 2016 Paris Marathon. Our department proposed to them an accompaniment to define a validated method to optimize their glycemic control and prevent acute metabolic complications through 2 preparatory races preceding the 2016 Paris Marathon
Who may be able to join
- Type 1 diabetes for more than 3 months
- who ran the 2016 Paris Marathon;
Who cannot join
- other than type 1 diabetes;
- uncontrolled diabetes with HbA1c> 9%;
- Pregnancy;
- Coronary heart disease contraindicated for marathon running;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glycemic Control Before, During and After the 2016 Paris Marathon in 12 Patients With Type 1 Diabetes Using Continuous Glucose Monitoring
This is an observational mono-centric retrospective study carried out at the University Hospital of Brest The main objective of this study is to assess the glycemic control before, during and after the 2016 Paris Marathon in patients with type 1 diabetes using continuous glucose measurement (CGM) by DEXCOM sensor.
Read the detailed description
Introduction
In patients with type 1 diabetes, there are general recommendations in the literature regarding carbohydrate intake and reduction of insulin doses in case of physical activity, but these recommendations should be tailored to individual patients. However, there is limited data on methods that could be applied in case of intense or extreme physical activity in patients with type 1 diabetes.
The diabetes department of Brest University Hospital has received many requests from type 1 diabetic patients for individual adaptation of insulin and carbohydrate consumption in order to participate in extreme sporting events such as marathons. One group of patients wanted to run the 2016 Paris Marathon. Our service had offered them support to define a validated method to optimize their glycemic control and prevent acute metabolic complications through 2 preparatory races preceding the Marathon de Paris 2016.
The main objective of this study is to assess the glycemic control before, during and after the 2016 Paris Marathon using continuous glucose measurement (CGM) by DEXCOM sensor.
Methods:
Study design
The study protocol consisted of 2 preparatory races (PR1 and PR2) and the Marathon. For each race, two visits were made 2 days before ("PRE" visit) and about 7 days after the race ("POST" visit).
At the first PRE visit (i.e., before PR1), patients were fitted with a DEXCOM G4® GDM device (Dexcom, San Diego, USA) to avoid a calibration problem during the periods of interest to record interstitial glycemia before, during and after each race (with calibration done in the first 24 hours). Patients were educated and trained by our care team on how to use the GCM device. Based on recommendations and our experience, patients were given advice on how to adjust their insulin therapy regimen and carbohydrate intake. In the remaining PRE visits, advice for adaptation of the insulin therapy regimen and carbohydrate intake was given to the patients based on the results of the GCM data from the previous preparatory race At the POST visit (D+7), the GCM device was removed and the GCM data was extracted using Diasend® Uploader 2.4.0 software. The GCM data was analyzed with the patient to debrief on blood glucose control during and after the race. The data was used to counsel the patient for the next race.
Preparatory race and marathon
Each patient had participated in two identical 2H preparatory races (PR1 between January and February 2016 and PR2 in March 2016). For each preparatory race, 2 or 3 groups of patients were constituted according to their physical conditions.
The Paris Marathon is a 42.195 km foot race organized every year since 1976 in the streets of Paris. On the day of the marathon, the medical and paramedical staff was divided into 3 groups. Each group was positioned at refreshment stations on the 19th, 30th and 42nd kilometers respectively.
- Conditions
- Marathon, Physical Activity, Type 1 Diabetes Mellitus, Education, Hypoglycemia
- Medical subject headings
- Motor Activity, Diabetes Mellitus, Type 1, Hypoglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC > 200 mg/dl and <70mg/dl during Marathon
Area under the curve (AUC in mg/dl/min) in hyperglycemia (AUC > 200 mg/dl) and hypoglycemia (AUC < 70 mg/dl)) over 3 periods: in the 24 hours before, during and within 72 hours after the Marathon.
Measured: up to five days
Time spent in hyper and hypoglycemia during Marathon
Percentage of time spent with blood glucose >200mg/dl, [70-200mg/dl] and <70mg/dl) during the Marathon
Measured: up to five hours
Secondary outcomes (4)
Insulin doses
Total, basal and prandial insulin doses for the periods before, during and after each run
Measured: up to five days
Carbohydrate intake
Amounts of carbohydrate intake in the periods before and during each race.
Measured: up to 1 day
AUC > 200 mg/dl and <70mg/dl during PR1 and PR2
Area under the curve (AUC in mg/dl/min) in hyperglycemia (AUC > 200 mg/dl) and hypoglycemia (AUC < 70 mg/dl)) over 3 periods: in the 24 hours before, during and within 72 hours after the PR1 and PR2
Measured: up to five days
Time spent in hyper and hypoglycemia during PR1 and PR2
Percentage of time spent with blood glucose >200mg/dl, [70-200mg/dl] and <70mg/dl) during the PR1 and PR2
Measured: up to five hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start15 Aug 2020
- Primary completion15 Sep 2020
- Study completion6 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MarathonStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926298
- Sponsor's protocol ID
- 29BRC20.0068
- Acronym
- MARADIAB
- Status last verified
- Feb 2025
- First submitted
- 8 Jun 2021
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Control Before, During and After the 2016 Paris Marathon in 12 Patients With Type 1 Diabetes Using Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT04926298
- Acronym / sponsor ID
- MARADIAB / 29BRC20.0068
- Conditions
- Marathon, Physical Activity, Type 1 Diabetes Mellitus, Education, Hypoglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 6 Dec 2020 (actual)
- First posted
- 15 Jun 2021 (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.
This is an observational mono-centric retrospective study carried out at the University Hospital of Brest The main objective of this study is to assess the glycemic control before, during and after the 2016 Paris Marathon in patients with type 1 diabetes using continuous glucose measurement (CGM) by DEXCOM sensor.
Detailed description
Introduction
In patients with type 1 diabetes, there are general recommendations in the literature regarding carbohydrate intake and reduction of insulin doses in case of physical activity, but these recommendations should be tailored to individual patients. However, there is limited data on methods that could be applied in case of intense or extreme physical activity in patients with type 1 diabetes.
The diabetes department of Brest University Hospital has received many requests from type 1 diabetic patients for individual adaptation of insulin and carbohydrate consumption in order to participate in extreme sporting events such as marathons. One group of patients wanted to run the 2016 Paris Marathon. Our service had offered them support to define a validated method to optimize their glycemic control and prevent acute metabolic complications through 2 preparatory races preceding the Marathon de Paris 2016.
The main objective of this study is to assess the glycemic control before, during and after the 2016 Paris Marathon using continuous glucose measurement (CGM) by DEXCOM sensor.
Methods:
Study design
The study protocol consisted of 2 preparatory races (PR1 and PR2) and the Marathon. For each race, two visits were made 2 days before ("PRE" visit) and about 7 days after the race ("POST" visit).
At the first PRE visit (i.e., before PR1), patients were fitted with a DEXCOM G4® GDM device (Dexcom, San Diego, USA) to avoid a calibration problem during the periods of interest to record interstitial glycemia before, during and after each race (with calibration done in the first 24 hours). Patients were educated and trained by our care team on how to use the GCM device. Based on recommendations and our experience, patients were given advice on how to adjust their insulin therapy regimen and carbohydrate intake. In the remaining PRE visits, advice for adaptation of the insulin therapy regimen and carbohydrate intake was given to the patients based on the results of the GCM data from the previous preparatory race At the POST visit (D+7), the GCM device was removed and the GCM data was extracted using Diasend® Uploader 2.4.0 software. The GCM data was analyzed with the patient to debrief on blood glucose control during and after the race. The data was used to counsel the patient for the next race.
Preparatory race and marathon
Each patient had participated in two identical 2H preparatory races (PR1 between January and February 2016 and PR2 in March 2016). For each preparatory race, 2 or 3 groups of patients were constituted according to their physical conditions.
The Paris Marathon is a 42.195 km foot race organized every year since 1976 in the streets of Paris. On the day of the marathon, the medical and paramedical staff was divided into 3 groups. Each group was positioned at refreshment stations on the 19th, 30th and 42nd kilometers respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The therapeutic education structure of the diabetes department of the University Hospital of Brest received numerous requests from patients with type 1 diabetes for the individual tailoring of insulin and carbohydrates intake to participate in extreme sports events such as a marathon. A group of patients wished to carry out the 2016 Paris Marathon. Our department proposed to them an accompaniment to define a validated method to optimize their glycemic control and prevent acute metabolic complications through 2 preparatory races preceding the 2016 Paris Marathon
Key inclusion criteria (2 listed)
- Type 1 diabetes for more than 3 months
- who ran the 2016 Paris Marathon;
Key exclusion criteria (4 listed)
- other than type 1 diabetes;
- uncontrolled diabetes with HbA1c> 9%;
- Pregnancy;
- Coronary heart disease contraindicated for marathon running;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AUC > 200 mg/dl and <70mg/dl during Marathon
Time frame: up to five days
Area under the curve (AUC in mg/dl/min) in hyperglycemia (AUC > 200 mg/dl) and hypoglycemia (AUC < 70 mg/dl)) over 3 periods: in the 24 hours before, during and within 72 hours after the Marathon.
Time spent in hyper and hypoglycemia during Marathon
Time frame: up to five hours
Percentage of time spent with blood glucose >200mg/dl, [70-200mg/dl] and <70mg/dl) during the Marathon
4 secondary outcomes
Insulin doses
Time frame: up to five days
Carbohydrate intake
Time frame: up to 1 day
AUC > 200 mg/dl and <70mg/dl during PR1 and PR2
Time frame: up to five days
Time spent in hyper and hypoglycemia during PR1 and PR2
Time frame: up to five hours
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 5 Feb 2025.
Related trials for Marathon
Recruiting
HEARTBEAT-TROP. Polyethylene Glycol Precipitation to Unmask Macrotroponin
Diagnoses Disease
RecruitingObservational study
Marathon of Hope Cancer Centres Network Study for Ontario (MOHCCN-O)
Breast Cancer, Colorectal Cancer
Enrolling by invitationObservational study
Longitudinal Study on the Evolution Trend and Influencing Factors of Postoperative Reflux of Esophageal Cancer Based on PEPTEST Technique
GASTROINTESTINAL NEOPLASMS
Enrolling by invitation
A Self-Directed Web-Based Education for Boston Marathon Runners With Patellofemoral Pain
Patellofemoral Pain
Active, not recruiting
The Effect of Probiotic Supplementation on the Exercise Performance of Long-distance Runners.
Intestinal Microbiome, Probiotic
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?
An observational study of Marathon and Physical Activity, run by University Hospital, Brest 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 2 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: finished, as of the sponsor's last update on 5 Feb 2025. 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?
AUC > 200 mg/dl and <70mg/dl during Marathon (time frame: up to five days). The study lists 2 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 5 Feb 2025.