Diabetes Mellitus, Type IDiabrasport2NCT02521675
Validation of Algorithms for Basal Insulin Rate Reductions in Type 1 Diabetic Patients Practising Physical Activity in Real Life Conditions
A study testing Usual algorithm, Diabrasport algorithm and Rest in people with Diabetes Mellitus, Type I and Adjustment of Basal Insulin Flow Rate During Physical Activity, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 17 sites in France.
Trial summary
There is no specific recommendations on the adjustments of the insulin treatment in the event of physical activity (PA) in T1D patients treated on insulin pump therapy. Patients often prefer additional carbohydrates intake rather than the reduction of their insulin doses because of the lack of specific algorithms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type I, Adjustment of Basal Insulin Flow Rate During Physical Activity, Adjustment of Prandial Insulin in Case of Physical Activity
- What is being tested?
- Usual algorithm, Diabrasport algorithm and Rest
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 17 sitesFrance
- Study dates
- Jan 2016to Mar 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged over 18 years
- Patient with type 1 diabetes for at least 1 year
- Patient receiving insulin pump under basal-prandial regimen for at least 3 months
- Patient practicing functional insulin therapy, or using a fixed plane defined food
- Patients with a stable basal rate for at least 1 week
- Patient practicing regular physical activity and reproducible identically
Show all 11Show fewer
- Patient with HbA1c older than 3 months between 6.5% and 9.5% (HbA1c ≤ 6.5% ≤ 9.5%)
- Patients with BMI ≤ 35
- Patient who agreed to participate in the study and who signed an informed consent
- Patient not participating in another protocol
- Patient covered by social security
Who cannot join
- Patients with a history of severe hypoglycemia without accidental cause in the 6 months preceding the entry in the protocol
- Patient not receiving its hypoglycaemia below the threshold of 0.5 g / L
- Patient with perforating foot ulcer or a known history of heart disease or obliterative arteriopathy of the lower limbs, or a history of cerebrovascular accident, or ongoing proliferative retinopathy or renal failure
- Patient with poorly controlled hypertension
- Pregnant woman
- Patients deprived of liberty by judicial or administrative decision, patients placed under legal guardianship
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Hôpital Universitaire
Angers, 49933
Hôpital Henri Duffaut
Avignon, 84902
Hôpital Jean Minjoz
Besançon, 25030
Hôpital Universitaire
Brest, 29609
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, 91100
Centre Hospitalier Louis Pasteur
Dole, 39108
Centre Hospitalier
Douai, 59507
Hôpital Universitaire
Grenoble, 38043
Fondation Hôtel Dieu du Creusot
Le Creusot, 71200
Centre Hospitalier Régional Universitaire
Lille, 59037
Centre Hospitalier Universitaire
Lyon, 69310
Hôpital de la Conception
Marseille, 13005
Study site
Mérignac, 33700
Centre Hospitalier Universitaire
Rennes, 35056
Centre Hospitalier
Saint-Dié, 88187
Centre Hospitalier Régional Universitaire
Strasbourg, 67000
Hôpital Jean Bernard
Valenciennes, 59322
About this study
Official title: Multicentre Randomized Cross-over Study Assessing in Type 1 Diabetic Patients With Pump Insulin the Non-inferiority of Glycemic Control Obtained With the Algorithms Tested in DIABRASPORT Versus the Rest Period Without Physical Activity
There is no specific recommendations on the adjustments of the insulin treatment in the event of physical activity (PA) in T1D patients treated on insulin pump therapy. Patients often prefer additional carbohydrates intake rather than the reduction of their insulin doses because of the lack of specific algorithms.
The DIABRASPORT 2 study aims to demonstrate that using algorithms DIABRASPORT, during a week of physical activity (PA), the incidence of hypoglycaemia is not different from that obtained during a week of rest without physical activity.
Read more
It is a multi-center European, controlled, randomized, cross-over, study, in 100 T1D patients practicing an occasional AP.
25 centers involved in this study.
After agreeing to participate in the study, patients will read the information leaflet, ask questions to the investigator physician and they will date and sign the consent form. The investigator physician will do the same.
They will be then drawn randomly via the electronic CRF (eCRF) to determine the order in which they will realize the rest vs DIABRASPORT sessions.
The study will take place in 5 weeks:
During the weeks Baseline and Diabrasport, patients will have to make 3 physical activity of 30 to 60 minutes separated by at least 24 hours:
- moderate activity 3 hours after lunch
- intense activity 3 hours after lunch
- activity moderate 90 min after lunch They will use their usual algorithms (Cho intake or adjustment of the dose of insulin) during the week Baseline and they will use the Diabrasport algorithm during the week Diabrasport.
Patients will be equipped with a holter Glycemic iPro2, Medtronic, whose data are hidden.
During the week of rest, patients should do no physical activity during the week. They will be equipped with the Glycemic holter.
Patients will have to fill a food survey the days they practice PA. Between each period, the patient must respect a period of wash-out for one week at least, during which he will be asked to not practice physical activity.
Validation of algorithms simple, easy to implement, adaptable by patients, could help to improve balance metabolic and practice of sport among the T1D.
- Conditions
- Diabetes Mellitus, Type I, Adjustment of Basal Insulin Flow Rate During Physical Activity, Adjustment of Prandial Insulin in Case of Physical Activity
- Being tested
- Usual algorithm, Diabrasport algorithm, Rest, Holter Glycemic Ipro2, Medtronic
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual algorithmBehavioural
The patient will be fitted with a CGMS (continuous glucose monitoring system) (data not shown) and it will be given the booklet to collect events + food survey
The patient goes home and he must perform 3 physical activities during the week (30-60 minutes) using its usual algorithms (glucose administration or adaptation of the BR), in the afternoon, and spacing them at least 24 hours :
- Moderate activity 3 hours after lunch
- Intense activity 3 hours after lunch
- Moderate activity 90 min after lunch These activities should not exceed 1 hour in wherever possible
Diabrasport algorithmBehavioural
The patient will be fitted with a CGMS (data not shown) and it will be given the booklet to collect events + food survey
The patient goes home and he must perform 3 physical activities during the week (identical to those carried out during the week "test algorithms usual" and during comparable periods) using DIABRASPORT algorithms, the afternoon and in the spacing at least 24 hours:
- Moderate activity 3 hours after lunch
- Intense activity 3 hours after lunch
- Moderate activity 90min after lunch These activities shall not exceed one hour
RestBehavioural
The patient will be fitted with a CGMS (data not shown) and it will be given the booklet to collect events + food survey.
The patient goes home and he will not perform any physical activity during the week
Holter Glycemic Ipro2, MedtronicDevice
| Study group | Role | What they receive |
|---|---|---|
| Diabrasport then Rest | Other | Between each period, the patient should respect a wash-out period of at least one week, during which they will be asked not to practice physical activity. Receives: Behavioral: Usual algorithm; Behavioral: Diabrasport algorithm; Behavioral: Rest; Device: Holter Glycemic Ipro2, Medtronic |
| Rest then Diabrasport | Other | Between each period, the patient should respect a wash-out period of at least one week, during which they will be asked not to practice physical activity. Receives: Behavioral: Usual algorithm; Behavioral: Diabrasport algorithm; Behavioral: Rest; Device: Holter Glycemic Ipro2, Medtronic |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of hypoglycemic events, defined by any threshold crossing 60 mg / dL (3.33mmol / L), measured in the interstitial glucose sensor continuously over a period of 24h
Measured: 24h
percentage of time spent over 24 hours in the euglycemic range [70; 180] mg / dL ([3.89, 10] mmol / L)
Measured: 24h
percentage of time spent over 24 hours in hyperglycemia (> 180 mg / dL) (> 10 mmol / L)
Measured: 24h
Secondary outcomes (10)
Number of hypoglycemic events, defined by any threshold crossing 70 mg / dL (3.9 mml / L), and <54 mg / dL (3 mmol / l) measured by interstitial continuous glucose sensors
Measured: 1 week
Number of hyperglycemic events, defined by any crossing of the threshold of 180 mg / dL (10 mml / L), measured by continuous interstitial glucose sensors.
Measured: 1 week
Metabolic goals analysis:
- percentage of time spent in the intervals [70; 180] and [80; 140] mg / dL, [3.89; 10] and [4.44; 7.78] mmol / L
- percentage of time passes hypoglycemia (<60mg / dL) (<3.33 mmol / L)
- percentage of time spent in hypoglycemia (<54mg / dL) (<3 mmol / L)
- percentage of time spent in hypoglycemia (<70mg / dL) (<3.89 mmol / L)
- percentage of time spent <80 mg / dL; (<4.44 mmol / L)
- percentage of time spent in hyperglycemia (> 180 mg / dL) (> 10 mmol / L)
- percentage of time spent> 140 mg / dL (> 7.78 mmol / L)
Measured: 1 week
Nadirs analysis of blood glucose during the night (value reached)
Measured: 1 week
Nadirs analysis of blood glucose during the night (time to onset)
Measured: 1 week
Analysis of quantities of glucose administration consumed during and at the waning of physical activity
Measured: 1 week
Comparison of average values of continuous glucose measurements according to the period (DIABRASPORT, rest and Baseline) and at different times of the day and night.
Measured: 1 week
Analysis by subgroups, depending on the type of physical activity and its duration, a link between a typology of physical activity or patients, and the number of hypoglycemia events during or waning of physical activity
Measured: 1 week
Analysis of evaluation questionnaires intensity PA (Borg) and quality of life (EVA)
Measured: 1 week
Comparison between number of hypoglycemic events predicted by the prediction function "DIABRASPORT" and number of hypoglycemic events actually occurred.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJan 2016
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IStudies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521675
- Sponsor's protocol ID
- 2015-A00709-40
- Acronym
- Diabrasport2
- Status last verified
- Apr 2021
- First submitted
- 6 Aug 2015
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomized Cross-over Study Assessing in Type 1 Diabetic Patients With Pump Insulin the Non-inferiority of Glycemic Control Obtained With the Algorithms Tested in DIABRASPORT Versus the Rest Period Without Physical Activity
- ClinicalTrials.gov ID
- NCT02521675
- Acronym / sponsor ID
- Diabrasport2 / 2015-A00709-40
- Conditions
- Diabetes Mellitus, Type I, Adjustment of Basal Insulin Flow Rate During Physical Activity, Adjustment of Prandial Insulin in Case of Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 13 Aug 2015 (estimated)
- 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.
There is no specific recommendations on the adjustments of the insulin treatment in the event of physical activity (PA) in T1D patients treated on insulin pump therapy. Patients often prefer additional carbohydrates intake rather than the reduction of their insulin doses because of the lack of specific algorithms.
The DIABRASPORT 2 study aims to demonstrate that using algorithms DIABRASPORT, during a week of physical activity (PA), the incidence of hypoglycaemia is not different from that obtained during a week of rest without physical activity.
It is a multi-center European, controlled, randomized, cross-over, study, in 100 T1D patients practicing an occasional AP.
25 centers involved in this study.
After agreeing to participate in the study, patients will read the information leaflet, ask questions to the investigator physician and they will date and sign the consent form. The investigator physician will do the same.
They will be then drawn randomly via the electronic CRF (eCRF) to determine the order in which they will realize the rest vs DIABRASPORT sessions.
The study will take place in 5 weeks:
During the weeks Baseline and Diabrasport, patients will have to make 3 physical activity of 30 to 60 minutes separated by at least 24 hours:
- moderate activity 3 hours after lunch
- intense activity 3 hours after lunch
- activity moderate 90 min after lunch They will use their usual algorithms (Cho intake or adjustment of the dose of insulin) during the week Baseline and they will use the Diabrasport algorithm during the week Diabrasport.
Patients will be equipped with a holter Glycemic iPro2, Medtronic, whose data are hidden.
During the week of rest, patients should do no physical activity during the week. They will be equipped with the Glycemic holter.
Patients will have to fill a food survey the days they practice PA. Between each period, the patient must respect a period of wash-out for one week at least, during which he will be asked to not practice physical activity.
Validation of algorithms simple, easy to implement, adaptable by patients, could help to improve balance metabolic and practice of sport among the T1D.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabrasport then Rest | Other | Behavioral: Usual algorithm, Behavioral: Diabrasport algorithm, Behavioral: Rest, Device: Holter Glycemic Ipro2, MedtronicBetween each period, the patient should respect a wash-out period of at least one week, during which they will be asked not to practice physical activity. |
| Rest then Diabrasport | Other | Behavioral: Usual algorithm, Behavioral: Diabrasport algorithm, Behavioral: Rest, Device: Holter Glycemic Ipro2, MedtronicBetween each period, the patient should respect a wash-out period of at least one week, during which they will be asked not to practice physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient aged over 18 years
- Patient with type 1 diabetes for at least 1 year
- Patient receiving insulin pump under basal-prandial regimen for at least 3 months
- Patient practicing functional insulin therapy, or using a fixed plane defined food
- Patients with a stable basal rate for at least 1 week
Key exclusion criteria (6 listed)
- Patients with a history of severe hypoglycemia without accidental cause in the 6 months preceding the entry in the protocol
- Patient not receiving its hypoglycaemia below the threshold of 0.5 g / L
- Patient with perforating foot ulcer or a known history of heart disease or obliterative arteriopathy of the lower limbs, or a history of cerebrovascular accident, or ongoing proliferative retinopathy or renal failure
- Patient with poorly controlled hypertension
- Pregnant woman
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 |
|---|---|---|
| Usual algorithmThe patient will be fitted with a CGMS (continuous glucose monitoring system) (data not shown) and it will be given the booklet to collect events + food survey The patient goes home and he must perform 3 physical activities during the week (30-60 minutes) using its usual algorithms (glucose administration or adaptation of the BR), in the afternoon, and spacing them at least 24 hours : * Moderate activity 3 hours after lunch * Intense activity 3 hours after lunch * Moderate activity 90 min after lunch These activities should not exceed 1 hour in wherever possible | Behavioural | Diabrasport then Rest, Rest then Diabrasport |
| Diabrasport algorithmThe patient will be fitted with a CGMS (data not shown) and it will be given the booklet to collect events + food survey The patient goes home and he must perform 3 physical activities during the week (identical to those carried out during the week "test algorithms usual" and during comparable periods) using DIABRASPORT algorithms, the afternoon and in the spacing at least 24 hours: * Moderate activity 3 hours after lunch * Intense activity 3 hours after lunch * Moderate activity 90min after lunch These activities shall not exceed one hour | Behavioural | Diabrasport then Rest, Rest then Diabrasport |
| RestThe patient will be fitted with a CGMS (data not shown) and it will be given the booklet to collect events + food survey. The patient goes home and he will not perform any physical activity during the week | Behavioural | Diabrasport then Rest, Rest then Diabrasport |
| Holter Glycemic Ipro2, Medtronic | Device | Diabrasport then Rest, Rest then Diabrasport |
Primary outcome
the number of hypoglycemic events, defined by any threshold crossing 60 mg / dL (3.33mmol / L), measured in the interstitial glucose sensor continuously over a period of 24h
Time frame: 24h
percentage of time spent over 24 hours in the euglycemic range [70; 180] mg / dL ([3.89, 10] mmol / L)
Time frame: 24h
percentage of time spent over 24 hours in hyperglycemia (> 180 mg / dL) (> 10 mmol / L)
Time frame: 24h
10 secondary outcomes
Number of hypoglycemic events, defined by any threshold crossing 70 mg / dL (3.9 mml / L), and <54 mg / dL (3 mmol / l) measured by interstitial continuous glucose sensors
Time frame: 1 week
Number of hyperglycemic events, defined by any crossing of the threshold of 180 mg / dL (10 mml / L), measured by continuous interstitial glucose sensors.
Time frame: 1 week
Metabolic goals analysis:
Time frame: 1 week
Nadirs analysis of blood glucose during the night (value reached)
Time frame: 1 week
Nadirs analysis of blood glucose during the night (time to onset)
Time frame: 1 week
Analysis of quantities of glucose administration consumed during and at the waning of physical activity
Time frame: 1 week
Comparison of average values of continuous glucose measurements according to the period (DIABRASPORT, rest and Baseline) and at different times of the day and night.
Time frame: 1 week
Analysis by subgroups, depending on the type of physical activity and its duration, a link between a typology of physical activity or patients, and the number of hypoglycemia events during or waning of physical activity
Time frame: 1 week
Analysis of evaluation questionnaires intensity PA (Borg) and quality of life (EVA)
Time frame: 1 week
Comparison between number of hypoglycemic events predicted by the prediction function "DIABRASPORT" and number of hypoglycemic events actually occurred.
Time frame: 1 week
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 8 Apr 2021.
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual algorithm, Diabrasport algorithm and Rest in people with Diabetes Mellitus, Type I and Adjustment of Basal Insulin Flow Rate During Physical Activity, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 17 sites 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 11 inclusion and 6 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
the number of hypoglycemic events, defined by any threshold crossing 60 mg / dL (3.33mmol / L), measured in the interstitial glucose sensor continuously over a period of 24h (time frame: 24h). The study lists 3 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 8 Apr 2021.