NCT01277965

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

April 22, 2013

Status Verified

January 1, 2012

Enrollment Period

2.9 years

First QC Date

January 14, 2011

Last Update Submit

April 19, 2013

Conditions

Type 1 Diabetes With a Subcutaneous Insulin PumpAdjustment of the Recommended Basal Insulin Flow Rate in the Event of Physical ActivityAdjustment of the Recommended Prandial Insulin in the Event of Physical Activity

Keywords

Algorithm basal insulinphysical activityType 1 diabetesInsulin pump treatment

Outcome Measures

Primary Outcomes (1)

  • Number of episodes of symptomatic or non-symptomatic hypoglycaemia

    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).

    24 hours

Secondary Outcomes (1)

  • Duration of hypoglycaemia

    24 hours

Study Arms (5)

50% VO2 max, BFR reduced by 50%

OTHER

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

50% VO2 max,BFR reduced by 80%

OTHER

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

75% VO2 max, BFR reduced by 80%

OTHER

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

75% VO2 max, pump switched off

OTHER

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

Rest

OTHER

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

Other: Rest

Interventions

50%VO2maxTBR50OTHER

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 50%
50%VO2max TBR80OTHER

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%

50% VO2 max,BFR reduced by 80%
75%VO2max TBR80OTHER

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, BFR reduced by 80%
75%VO2max TBR100OTHER

Turning off the pump (75%VO2max TBR100).However, in order to maintain the study blindfold, the pump will be switched off but not removed

75% VO2 max, pump switched off
RestOTHER

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

Rest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, Essonne, 91100, France

Location

MeSH Terms

Conditions

Motor ActivityDiabetes Mellitus, Type 1

Interventions

RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

BehaviorDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sylvia FRANC, PH

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 17, 2011

Study Start

March 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

April 22, 2013

Record last verified: 2012-01

Locations

FR(1)