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Closed-loop Control of Glucose Levels (Artificial Pancreas) During Exercise in Adults With Type 1 Diabetes

1. maj 2015 opdateret af: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

An Open-label, Randomized, Cross-over Study to Compare the Efficacy of Single-hormone Closed-loop Strategy and Dual-hormone Closed-loop Strategy at Regulating Glucose Levels During Continuous Exercise and Interval Exercise in Adults With Type-1 Diabetes

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.

The objective is to compare the efficacy of single-hormone closed-loop strategy and dual-hormone closed-loop strategy at regulating glucose levels during continuous exercise and interval exercise.

The investigator hypothesized that dual-hormone closed-loop strategy is superior to single-hormone closed-loop strategy in regulating glucose levels during exercise periods.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.

We aim to conduct a randomized two-way cross-over trial comparing single-hormone closed-loop strategy and dual-hormone closed-loop strategy to compare the two interventions during exercise periods in adults with type 1 diabetes. A moderate intensity exercise will be performed for 60 minutes at 60% of the maximum oxygen consumption (VO2max). A high intensity exercise will be 40 minutes of interval training. The interval training will be preceded by a 10 minutes warm-up and followed by a 10 minutes cool down.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2W 1R7
        • Institut de recherches cliniques de Montreal

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Males and females ≥ 18 years of old.
  • Clinical diagnosis of type 1 diabetes for at least one year.
  • The subject will have been on insulin pump therapy for at least 3 months.
  • Last (less than 3 months) HbA1c ≤ 12%.

Exclusion Criteria:

  • Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
  • Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • Ongoing pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
  • Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
  • Problems with venous access

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Single-hormone closed-loop system
In single-hormone closed-loop system, variable subcutaneous insulin infusion rate will be used to regulate glucose levels
Andet: 60-minute exercise
Patients will be admitted at the research clinical facility at 14:30. Closed-loop strategy will start at 15:30. At 18:00, patients will performed a 60-minute exercise at 60% of VO2 max. Patients will be discharged at 20:00.
Andet: 40-minute interval exercise
Patients will be admitted at the research clinical facility at 14:30. Closed-loop strategy will start at 15:30. At 18:00, patients will performed a 40-minute interval exercise. Patients will be discharged at 20:00.
Aktiv komparator: Dual-hormone closed-loop system
In dual-hormone closed-loop system, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels
Andet: 60-minute exercise
Patients will be admitted at the research clinical facility at 14:30. Closed-loop strategy will start at 15:30. At 18:00, patients will performed a 60-minute exercise at 60% of VO2 max. Patients will be discharged at 20:00.
Andet: 40-minute interval exercise
Patients will be admitted at the research clinical facility at 14:30. Closed-loop strategy will start at 15:30. At 18:00, patients will performed a 40-minute interval exercise. Patients will be discharged at 20:00.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The number of patients experiencing exercise-induced hypoglycemia requiring dextrose infusion (< 3.3 mmol/L symptomatic or < 3.0 mmol/L regardless of symptoms).
Tidsramme: 18:00 hours to 19:30 hours
18:00 hours to 19:30 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Decrease in glucose levels during each exercise
Tidsramme: 18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed
Difference between glucose levels at the beginning of the exercise and the lowest glucose level from the start of the exercise until 30 minutes after exercise).
18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed
Area under the curve of plasma glucose levels < 4 mmol/L
Tidsramme: 15:30 hours to 19:30 hours
15:30 hours to 19:30 hours
Percentage of time of plasma glucose levels < 4 mmol/L
Tidsramme: 15:30 hours to 19:30 hours
15:30 hours to 19:30 hours
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Tidsramme: 15:30 hours to 19:30 hours
15:30 hours to 19:30 hours
Decremental area under the curve from the start of the exercise for 90 minutes.
Tidsramme: 18:00 to 19:30
18:00 to 19:30
Percentage of time-in-target defined as between 4 and 10 mmol/L
Tidsramme: 15:30 hours to 19:30 hours
15:30 hours to 19:30 hours
Mean time (minutes) to the first hypoglycemic event during the exercise period
Tidsramme: 18:00 to 19:00
18:00 to 19:00
The amount of dextrose infused
Tidsramme: 15:30 to 19:30
15:30 to 19:30

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institut de Recherches Cliniques de Montreal

Samarbejdspartnere

Société Francophone du Diabète

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2014

Primær færdiggørelse (Faktiske)

1. april 2015

Studieafslutning (Faktiske)

1. april 2015

Datoer for studieregistrering

Først indsendt

23. august 2013

Først indsendt, der opfyldte QC-kriterier

27. august 2013

Først opslået (Skøn)

28. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2015

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CLASS-06

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 1 diabetes

Kliniske forsøg med 60-minute exercise

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