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Validation of Algorithms for Basal Insulin Rate Reductions in Type 1 Diabetic Patients Practising Physical Activity in Real Life Conditions (Diabrasport2)

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ClinicalTrials.gov Identifier: NCT02521675
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type I Adjustment of Basal Insulin Flow Rate During Physical Activity Adjustment of Prandial Insulin in Case of Physical Activity Behavioral: Usual algorithm Behavioral: Diabrasport algorithm Behavioral: Rest Device: Holter Glycemic Ipro2, Medtronic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Diabrasport then Rest
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.
Behavioral: Usual algorithm

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

Behavioral: Diabrasport algorithm

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

Behavioral: Rest

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


Device: Holter Glycemic Ipro2, Medtronic
Rest then Diabrasport
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.
Behavioral: Usual algorithm

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

Behavioral: Diabrasport algorithm

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

Behavioral: Rest

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


Device: Holter Glycemic Ipro2, Medtronic



Primary Outcome Measures :
  1. 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 ]
  2. percentage of time spent over 24 hours in the euglycemic range [70; 180] mg / dL ([3.89, 10] mmol / L) [ Time Frame: 24h ]
  3. percentage of time spent over 24 hours in hyperglycemia (> 180 mg / dL) (> 10 mmol / L) [ Time Frame: 24h ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Metabolic goals analysis: [ Time Frame: 1 week ]
    • 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)

  4. Nadirs analysis of blood glucose during the night (value reached) [ Time Frame: 1 week ]
  5. Nadirs analysis of blood glucose during the night (time to onset) [ Time Frame: 1 week ]
  6. Analysis of quantities of glucose administration consumed during and at the waning of physical activity [ Time Frame: 1 week ]
  7. 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 ]
  8. 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 ]
  9. Analysis of evaluation questionnaires intensity PA (Borg) and quality of life (EVA) [ Time Frame: 1 week ]
  10. Comparison between number of hypoglycemic events predicted by the prediction function "DIABRASPORT" and number of hypoglycemic events actually occurred. [ Time Frame: 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02521675


Contacts
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Contact: Sylvia Franc, MD sylvia.franc@free.fr

Locations
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France
Hôpital Universitaire Recruiting
Angers, France, 49933
Principal Investigator: Séverine Dubois, MD         
Sub-Investigator: Ingrid Allix, MD         
Hôpital Henri Duffaut Not yet recruiting
Avignon, France, 84902
Principal Investigator: Eric Benamo, MD         
Sub-Investigator: Françoise Plat, MD         
Hôpital Jean Minjoz Recruiting
Besançon, France, 25030
Principal Investigator: Sophie Borot, MD         
Sub-Investigator: Annie Clergeot, MD         
Centre Hospitalier Withdrawn
Boulogne sur Mer, France, 62321
Hôpital Universitaire Recruiting
Brest, France, 29609
Principal Investigator: Véronique Kerlan, MD         
Sub-Investigator: Emmanuel Sonnet, MD         
Centre Hospitalier Alpes-Léman Withdrawn
Contamine sur Arve, France, 74130
Centre Hospitalier Sud-Francilien Recruiting
Corbeil-Essonnes, France, 91100
Principal Investigator: Sylvia Franc, MD         
Sub-Investigator: Alfred Penfornis, MD PHD         
Sub-Investigator: Guillaume Charpentier, MD         
Sub-Investigator: Ahmed Daoudi, MD         
Centre Hospitalier Louis Pasteur Recruiting
Dole, France, 39108
Principal Investigator: Muriel Tschudnowski, MD         
Centre Hospitalier Not yet recruiting
Douai, France, 59507
Principal Investigator: Régis Bresson, MD         
Hôpital Pierre Zobda-Quitman Withdrawn
Fort De France, France, 97261
Hôpital Universitaire Active, not recruiting
Grenoble, France, 38043
Fondation Hôtel Dieu du Creusot Not yet recruiting
Le Creusot, France, 71200
Principal Investigator: Sylvaine Clavel, MD         
Centre Hospitalier Régional Universitaire Recruiting
Lille, France, 59037
Principal Investigator: Anne Vambergue, MD PHD         
Sub-Investigator: Florence Baudoux, MD         
Centre Hospitalier Universitaire Recruiting
Lyon, France, 69310
Principal Investigator: Charles Thivolet, MD PHD         
Hôpital de la Conception Recruiting
Marseille, France, 13005
Principal Investigator: Pauline Schaepelynck, MD         
Sub-Investigator: Marie-Françoise Jannot-Lamotte, MD         
Sub-Investigator: Clémence Treglia, MD         
Recruiting
Merignac, France, 33700
Contact: Anne Navaranne Roumec, MD         
Principal Investigator: Anne Navaranne Roumec, MD         
Withdrawn
Noisy le Grand, France, 93160
Hôpital Cochin Withdrawn
Paris, France, 75014
Hôpital Lariboisière Withdrawn
Paris, France, 75475
Centre Hospitalier Universitaire Recruiting
Rennes, France, 35056
Principal Investigator: Anne-Marie Leguerrier, MD         
Centre Hospitalier Not yet recruiting
Saint Dié des Vosges, France, 88187
Principal Investigator: Pascal Mattei, MD         
Centre Hospitalier Régional Universitaire Recruiting
Strasbourg, France, 67000
Principal Investigator: Nathalie Jeandidier, MD PHD         
Sub-Investigator: Dominique Paris, MD         
Sub-Investigator: François Moreau, MD         
Hôpital Jean Bernard Completed
Valenciennes, France, 59322
Centre Hospitalier Les Portes du Sud Withdrawn
Venissieux, France, 69200
Sponsors and Collaborators
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

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Responsible Party: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier: NCT02521675     History of Changes
Other Study ID Numbers: 2015-A00709-40
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs