Validation of Algorithms for Basal Insulin Rate Reductions in Type 1 Diabetic Patients Practising Physical Activity (DIABRASPORT)

This study has been completed.
Sponsor:
Collaborator:
European Association for the Study of Diabetes
Information provided by (Responsible Party):
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier:
NCT01277965
First received: January 14, 2011
Last updated: April 19, 2013
Last verified: January 2012
  Purpose

Primary aim:

To show that in subjects with type 1 diabetes with a subcutaneous continuous insulin infusion, adjustment of the recommended basal insulin flow rate in the event of physical activity allows the subjects to practice sports without any increase in incidence of hypoglycaemia during physical activity or the ensuing hours.

(NB: hypoglycaemia is defined as blood glucose less than 3 mmol/l or 0,54 g/l in accordance with the EMEA definition).

The proposed algorithms consist of a temporary reduction in basal flow of 50 percent or 80 percent (temporary basal flow TBR50 or TBR80) depending on the intensity of physical activity (50 percent of VO2max or 75 percent of VO2max). Switching off the pump will also be studied as an option to adjust insulin dosage in the event of unprogrammed physical activity (temporary reduction of basal flow by 100 percent).

Secondary aims:

  • Characterisation of hypoglycaemia during and after physical activity based on CGMS data: symptomatic or non-symptomatic nature of hypoglycaemia, time to onset of hypoglycaemia in relation to the start of physical activity, degree and severity of hypoglycaemia.
  • Evaluation of overall variations in blood glucose in the event of physical activity using CGMS data (area under the curve).
  • Evaluation of glucose restoration methods used in the event of hypoglycaemia.
  • Analysis of subgroups of patients with and without hypoglycaemia.

Condition Intervention
Type 1 Diabetes With a Subcutaneous Insulin Pump
Adjustment of the Recommended Basal Insulin Flow Rate in the Event of Physical Activity
Adjustment of the Recommended Prandial Insulin in the Event of Physical Activity
Other: 50%VO2maxTBR50
Other: 50%VO2max TBR80
Other: 75%VO2max TBR80
Other: 75%VO2max TBR100
Other: Rest

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Use of a CMGS to Validate Algorithms for Basal Insulin Rate Reductions in Type 1 Diabetic Patients Treated With Subcutaneous Continuous Insulin Infusion and Practicing Physical Activity

Resource links provided by NLM:


Further study details as provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:

Primary Outcome Measures:
  • Number of episodes of symptomatic or non-symptomatic hypoglycaemia [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Number of episodes of symptomatic or non-symptomatic hypoglycaemia detected by CGMS throughout the duration of physical activity and subsequent hours until the next morning (threshold: 3 mmol/l or 0.54 g/l).


Secondary Outcome Measures:
  • Duration of hypoglycaemia [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Duration of hypoglycaemia (min), total time in hypoglycaemia (min, %), time to onset of hypoglycaemia after the start of physical activity, degree (blood glucose level) and severity of hypoglycaemia, area under the algebraic curve during physical activity and in the following hours, nadir of the intervening glucose curve.


Estimated Enrollment: 20
Study Start Date: March 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
50% VO2 max, BFR reduced by 50%
The basal rate of the pump will be adjusted in accordance with the intensity of physical activity being performed for moderate physical activity (50% VO2max),a temporary basal rate will be reduced by 50%
Other: 50%VO2maxTBR50
The basal rate of the pump will be adjusted in accordance with the intensity of physical activity being performed for moderate physical activity (50% VO2max),a temporary basal rate will be reduced by 50%
50% VO2 max,BFR reduced by 80%
The basal rate of the pump will be adjusted in accordance with the intensity of physical activity being performed for moderate physical activity (50% VO2max),a temporary basal rate will be reduced by 80%
Other: 50%VO2max TBR80
The basal rate of the pump will be adjusted in accordance with the intensity of physical activity being performed for moderate physical activity (50% VO2max),a temporary basal rate will be reduced by 80%
75% VO2 max, BFR reduced by 80%
The basal rate of the pump will be adjusted in accordance with the intensity of physical activity being performed for moderate physical activity (75% VO2max),a temporary basal rate will be reduced by 80%.
Other: 75%VO2max TBR80
The basal rate of the pump will be adjusted in accordance with the intensity of physical activity being performed for moderate physical activity (75% VO2max),a temporary basal rate will be reduced by 80%
75% VO2 max, pump switched off
Turning off the pump (75%VO2max TBR100).However, in order to maintain the study blindfold, the pump will be switched off but not removed.
Other: 75%VO2max TBR100
Turning off the pump (75%VO2max TBR100).However, in order to maintain the study blindfold, the pump will be switched off but not removed
Rest
Patient will be in rest, basal insulin flow rate will not be change.
Other: Rest
Patient will be in rest, basal insulin flow rate will not be change

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged over 18 years, presenting type 1 diabetes for at least 1 year
  • Patients on basal-prandial regimen treated with functional insulin therapy
  • Patients with a subcutaneous insulin pump for at least 3 months
  • Patients with HbA1c < 9% less than 3 months before
  • Patients with stable basal flow for at least 1 week
  • Patients able to pedal
  • Patients covered by social security
  • Patients consenting to take part in the study and having signed a written informed consent form.

Exclusion Criteria:

  • Patients with a history of severe hypoglycaemia in the 6 months prior to entry into the study
  • Patients unable to detect their hypoglycaemia
  • Patients 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.
  • Patients with poorly controlled hypertension
  • Women either pregnant or likely to become pregnant
  • Patients deprived of liberty by judicial or administrative decision, patients placed under legal guardianship.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277965

Locations
France
Centre Hospitalier Sud Francilien
Corbeil Essonnes, Essonne, France, 91100
Sponsors and Collaborators
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
European Association for the Study of Diabetes
Investigators
Principal Investigator: Sylvia FRANC, PH Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
  More Information

No publications provided

Responsible Party: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier: NCT01277965     History of Changes
Other Study ID Numbers: 2009 A01136 51
Study First Received: January 14, 2011
Last Updated: April 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:
Algorithm basal insulin
physical activity
Type 1 diabetes
Insulin pump treatment

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014