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Initial Testing of the Diabeloop Algorithm in T1D Patients on Pump Therapy Over the Prandial Period and Physical Activity. (DiabeloopWP6-0)

Development of the Glycemic Control Algorithm, in Prandial and Physical Effort Situations.

The main objective is to assess if the Diabeloop algorithm provides better glycemic control than a "manual" usual algorithm of patients with type 1 diabetes treated by insulin pump during meals, and during activity qualified "moderate" to "severe" by the patients.

The study will be conducted in 18 patients. The investigation centers are: CHSF (for Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop algorithm test during meals.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

  • Grenoble and Toulouse will test the prandial algorithm with several carbohydrate intake and a primer of 50% or 75% of the total bolus. Groups of patients are described as follows:

    • Group I: patients have a meal with the usual carbohydrate intake. The meal bolus is made according to the current treatment.
    • Group II: patients have a meal with a "low" carbohydrate intake (50% reduction of carbohydrate).
    • Group III: patients have a meal with a "strong" carbohydrate intake (increase 50% of carbohydrate).
    • Group IV: patients of group IV have each meal with carbohydrate intake but their usual bolus will be omitted.
    • Inclusion visit V1: The study will be proposed at the patients who meet the inclusion criteria. After signing the consent, the investigator shall designate one group for each patient.
    • Visit V2 (24 hours before the visit V3): Installation, calibration and education of two glucose sensors dexcom G4 ™ will be performed by a nurse. The patient will keep two sensors until the end of the study (end of V4).
    • Visit V3 (algorithm test): Patient will be fitted with its insulin pump and the two sensors dexcom G4 ™. These will be coupled by the engineer LETI to the computer on which is installed the control algorithm to be tested. Lunch will be taken at 1 pm. The algorithm will provide proposals insulin every 15 minutes until 6 pm.
    • Visit V4 (patient control): Patient will be fitted with two sensors dexcom G4 ™ and its insulin pump programmed according to the usual algorithm. The meal will be taken at 1h PM. Patient can leave the site at 6 pm after removal of sensors.
  • CHSF (Centre Hospitalier Sud Francilien) will test the algorithm glycemic control during physical activity of moderate (50% VO2max) or high intensity (75% VO2max) for 30 minutes on a bicycle ergometer. In different situations, three patient groups will be created:

    • Group A: Patients practice an "average" physical activity(50% VO2max) with usual temporary basal reduction (usually 50% of reduction during the test and 2h next).
    • Group B: Patients practice an "intense" physical activity (75% VO2max) with usual temporary basal reduction (usually 80% of reduction during the test and 2h after).
    • Group C: patients practice an "average" physical activity (50% VO2max) but without concomitant reduction of temporary basal.
    • Inclusion visit V1 : The study will be proposed at the patients who meet the inclusion criteria. After signing the consent, the investigator shall designate one group for each patient.
    • Visit V2 : Patient will be equipped with two sensors dexcom G4 ™ and a heart rate monitor. Calibrated meal is expected at 11h 30 pm. The patient will be administered his insulin dose according to his usual algorithm. The physical test will begin three hours after the meal. It will be carried on bicycle ergometer for 30 minutes at an medium or high intensity. (Average = 50% VO2max, or high level = 75% VO2max).
    • Visit V3: The same test is repeated for each patient during this visit. Its insulin pump will be controlled by the doses proposal of the algorithm after manual validation by the investigator. These will continue until the next morning, and the patient will spend overnight in the hospital.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

18

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Evry, Frankrijk, 91058
        • Centre Hospitalier Sud Francilien
      • Grenoble, Frankrijk, 38043
        • University hospital of Grenoble
      • Toulouse, Frankrijk, 31403
        • University Hospital of Toulouse

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Patients with type 1 diabetes treated by external insulin pump;
  • Patients with HbA1c <8.5%.
  • Patients aged 18 years or less;
  • Patient who signed consent;
  • Patient affiliated with Social Security.

For Grenoble and Toulouse Centers (Prandial algorithm test : MEAL):

  • Patient is practicing functional insulin therapy is a fixed meal plan.

For CHSF center (test of algorithm during activity):

  • Patient able to perform moderate or intense activity during 30 minutes.

Exclusion Criteria:

  • Patients with type 2 diabetes
  • All serious diseases that could interfere with the study
  • Insulin resistance and obesity (BMI> 30 kg/m2 and / or insulin requirements> 2 U / kg / day)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Proposed treatment by Diabeloop algorithm
the insulin dose is calculated by the algorithm based on the usual treatment of the patient, the ratio I / C, the intensity of physical activity and blood glucose sensor.
the intervention is applied only at the dose of insulin
Geen tussenkomst: usual treatment

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Time spent in glucose reference intervals
Tijdsspanne: After the end of the tests
After the end of the tests

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Measuring glucose sensor 2h, 3h and 4h post-prandial and AUC, in every situation tested to evaluate the efficacy and safety (time spent in hypoglycemia)
Tijdsspanne: After the end of the tests
To evaluate the efficacy and safety of prandial algorithm, informed carbohydrate intake by the patient either quantitatively or semi-quantitative, or not informed way.
After the end of the tests

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Comparison of glucose sensor 2h, 3h and 4h post-prandial and AUC in conditions identical meals for each trigger level (50 or 75%). Measuring AUC during and 2 hours after physical activity, then to lunch time, during dinner and throughout the night.
Tijdsspanne: After the end of the tests
  1. Comparison of glucose sensor 2h, 3h and 4h post-prandial and AUC, in conditions identical meals for each trigger level (50 or 75%).
  2. Comparison of blood glucose 2h, 3h and 4h post-prandial and AUC, in conditions identical meals for each trigger level, in three configurations: quantitative, semi-quantitative and bolus omitted.
  3. Measuring AUC, during and 2 hours after physical activity, then to lunch time, during dinner and throughout the night;
  4. Measure the time spent in hypoglycemia (<0.70 g / l)
  5. Measuring the number of carbohydrate ingested
After the end of the tests

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie stoel: Guillaume CHARPENTIER, MD, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
  • Hoofdonderzoeker: Sylvia Franc, MD, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
  • Hoofdonderzoeker: Pierre-Yves BENHAMOU, Pr., CHU of Grenoble

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2013

Primaire voltooiing (Werkelijk)

1 juni 2013

Studie voltooiing (Werkelijk)

1 juli 2013

Studieregistratiedata

Eerst ingediend

18 december 2012

Eerst ingediend dat voldeed aan de QC-criteria

18 december 2012

Eerst geplaatst (Schatting)

21 december 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

27 oktober 2014

Laatste update ingediend die voldeed aan QC-criteria

24 oktober 2014

Laatst geverifieerd

1 oktober 2014

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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