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

NCT02521675 | Completed

• 1 other identifier: 2015-A00709-40
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 17

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.

Conditions

Diabetes Mellitus, Type I; Adjustment of Basal Insulin Flow Rate During Physical Activity; Adjustment of Prandial Insulin in Case of Physical Activity

Outcome Measures

Primary Outcomes (3)

• 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

  24h

• percentage of time spent over 24 hours in the euglycemic range [70; 180] mg / dL ([3.89, 10] mmol / L)

  24h

• percentage of time spent over 24 hours in hyperglycemia (> 180 mg / dL) (> 10 mmol / L)

  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

  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.

  1 week

• Metabolic goals analysis:

  1 week

• Nadirs analysis of blood glucose during the night (value reached)

  1 week

• Nadirs analysis of blood glucose during the night (time to onset)

  1 week

Study Arms (2)

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.

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.

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

Interventions

Usual algorithm BEHAVIORAL

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 then Rest; Rest then Diabrasport

Diabrasport algorithm BEHAVIORAL

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

Diabrasport then Rest; Rest then Diabrasport

Rest BEHAVIORAL

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

Diabrasport then Rest; Rest then Diabrasport

Holter Glycemic Ipro2, Medtronic DEVICE

Diabrasport then Rest; Rest then Diabrasport

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète: lead

Study Sites (17)

Hôpital Universitaire

Angers, 49933, France

Location

Hôpital Henri Duffaut

Avignon, 84902, France

Location

Hôpital Jean Minjoz

Besançon, 25030, France

Location

Hôpital Universitaire

Brest, 29609, France

Location

Centre Hospitalier Sud-Francilien

Corbeil-Essonnes, 91100, France

Location

Centre Hospitalier Louis Pasteur

Dole, 39108, France

Location

Centre Hospitalier

Douai, 59507, France

Location

Hôpital Universitaire

Grenoble, 38043, France

Location

Fondation Hôtel Dieu du Creusot

Le Creusot, 71200, France

Location

Centre Hospitalier Régional Universitaire

Lille, 59037, France

Location

Centre Hospitalier Universitaire

Lyon, 69310, France

Location

Hôpital de la Conception

Marseille, 13005, France

Location

Unknown Facility

Mérignac, 33700, France

Location

Centre Hospitalier Universitaire

Rennes, 35056, France

Location

Centre Hospitalier

Saint-Dié, 88187, France

Location

Centre Hospitalier Régional Universitaire

Strasbourg, 67000, France

Location

Hôpital Jean Bernard

Valenciennes, 59322, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 13, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

FR (17)