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Hybrid Artificial Pancreas in Home Setting (AP Hybrid)

5 november 2015 uppdaterad av: University Hospital, Montpellier

Assessment of Hybrid Use of an Artificial Pancreas in a Home Setting for Two Months in Patients With Type 1 Diabetes

The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in home setting in Type 1 Diabetic patients

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

During this study, we propose to assess an Artificial Pancreas in a group of Type 1 diabetic patients who will participate in two study periods of two-month duration with an insulin pump and a Continuous Glucose Monitoring (CGM) device. During one of these periods, called HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.

Studietyp

Interventionell

Inskrivning (Faktisk)

36

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Montpellier, Frankrike, 34000
        • CHU Montpellier
  • Italien
      • Padova, Italien
        • University of Padova
  • Nederländerna
      • Amsterdam, Nederländerna
        • University of Amsterdam

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Age ≥ 18 et < 70 years old
  2. Having diabetes according to WHO criteria for at least 6 months, and Type 1 diabetes according to ADA criteria
  3. Under basal-bolus insulin therapy using an external insulin pump for at least 3 months
  4. BMI < 35 kg/m²
  5. Willing to wear a CGM device for the whole duration of the study, except during washout period, combined with the DiAs platform during the evening and night-time for 2 months
  6. Trained in carbohydrate counting
  7. HbA1c > 7.5 % and < 10%
  8. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, stability on the medication for at least 1 month prior to study inclusion
  9. Willing to undergo all study procedures
  10. Informed consent signed

Exclusion criteria:

  1. Pregnancy or breast feeding, or intention to be pregnant during the study duration
  2. Use of a medication that significantly impacts glucose metabolism, e.g. steroids
  3. Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
  4. Patient plans to go abroad during the trial period
  5. Patient is expected to be out-of-home in the evening and during night time (e.g. shift-workers, etc.) more than 25% of a study period
  6. Patient does not hold any nearby party for assistance if needed
  7. Patient with severe hypoglycemia including coma, mental confusion and/or convulsions requesting IV glucose injection or glucagon injection during the last year.
  8. Presence of any malignant disease, unless considered as cured for more than 10 years
  9. History of acute cardiovascular event during the prior year
  10. History of diabetic keto-acidosis during the prior 6 months
  11. Renal insufficiency with creatinin > 150 μmol/L
  12. Impairment of liver status estimated from ASAT/ALAT plasma levels > 2x upper limits of normal values
  13. Impaired cognitive or psychological abilities which may result in defective adherence to study conditions

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: HYBRID-OPEN

Patients are randomized on the schedule; hybrid period and after open period. During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.

During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.
Enhet: HYBRID
During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.
Enhet: OPEN
During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.
Experimentell: OPEN-HYBRID

Patients are randomized on the schedule: open period and after hybrid period. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.

During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.
Enhet: HYBRID
During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.
Enhet: OPEN
During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Percent time spent in target range (3.9-10.0 mmol/L or 70-180 mg/dL) during each study period
Tidsram: during 2 months-hybrid period and during 2 months-open period
during 2 months-hybrid period and during 2 months-open period

Sekundära resultatmått

Resultatmått
Tidsram
Low Blood Glucose Index (LBGI)
Tidsram: for each period of 2 month (hybrid period and open period)
for each period of 2 month (hybrid period and open period)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Montpellier

Utredare

  • Huvudutredare: Eric ER RENARD, MD, University Hospital, Montpellier

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2014

Primärt slutförande (Faktisk)

1 juni 2015

Avslutad studie (Faktisk)

1 juni 2015

Studieregistreringsdatum

Först inskickad

29 maj 2014

Först inskickad som uppfyllde QC-kriterierna

30 maj 2014

Första postat (Uppskatta)

2 juni 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

6 november 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 november 2015

Senast verifierad

1 november 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 8628 4

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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