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

1. mai 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

15

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2W 1R7
        • Institut de Recherches Cliniques de Montreal

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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
Annen: 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.
Annen: 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
Annen: 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.
Annen: 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.

Hva måler studien?

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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Institut de Recherches Cliniques de Montreal

Samarbeidspartnere

Société Francophone du Diabète

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2014

Primær fullføring (Faktiske)

1. april 2015

Studiet fullført (Faktiske)

1. april 2015

Datoer for studieregistrering

Først innsendt

23. august 2013

Først innsendt som oppfylte QC-kriteriene

27. august 2013

Først lagt ut (Anslag)

28. august 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

4. mai 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. mai 2015

Sist bekreftet

1. mai 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CLASS-06

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