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

Summary

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.

Conditions

• 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

Interventions

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%

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%

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%

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

OTHER

Rest

Patient will be in rest, basal insulin flow rate will not be change

Sponsors & Collaborators

• European Association for the Study of Diabetes

  collaborator OTHER

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

  lead OTHER

Principal Investigators

• Sylvia FRANC, PH · Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2013-02-28

Completion

2013-02-28

Countries

• France

Study Locations