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

Diabetes Mellitus, Type I Clinical Trial

— Diabrasport2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521675
• Other study ID #: 2015-A00709-40
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 2020

Study information

• Verified date: April 2021
• Source: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adjustment of Basal Insulin Flow Rate During Physical Activity
• Adjustment of Prandial Insulin in Case of Physical Activity
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type I

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
France	Hôpital Universitaire	Angers
France	Hôpital Henri Duffaut	Avignon
France	Hôpital Jean Minjoz	Besançon
France	Hôpital Universitaire	Brest
France	Centre Hospitalier Sud-Francilien	Corbeil-Essonnes
France	Centre Hospitalier Louis Pasteur	Dole
France	Centre Hospitalier	Douai
France	Hôpital Universitaire	Grenoble
France	Fondation Hôtel Dieu du Creusot	Le Creusot
France	Centre Hospitalier Régional Universitaire	Lille
France	Centre Hospitalier Universitaire	Lyon
France	Hôpital de la Conception	Marseille
France	Centre Hospitalier Universitaire	Rennes
France	Centre Hospitalier	Saint Dié des Vosges
France	Centre Hospitalier Régional Universitaire	Strasbourg
France	Hôpital Jean Bernard	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	percentage of time spent over 24 hours in the euglycemic range [70; 180] mg / dL ([3.89, 10] mmol / L)		24h
Primary	percentage of time spent over 24 hours in hyperglycemia (> 180 mg / dL) (> 10 mmol / L)		24h
Secondary	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
Secondary	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
Secondary	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)	1 week
Secondary	Nadirs analysis of blood glucose during the night (value reached)		1 week
Secondary	Nadirs analysis of blood glucose during the night (time to onset)		1 week
Secondary	Analysis of quantities of glucose administration consumed during and at the waning of physical activity		1 week
Secondary	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.		1 week
Secondary	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		1 week
Secondary	Analysis of evaluation questionnaires intensity PA (Borg) and quality of life (EVA)		1 week
Secondary	Comparison between number of hypoglycemic events predicted by the prediction function "DIABRASPORT" and number of hypoglycemic events actually occurred.		1 week