Closed-loop Control of Glucose Levels (Artificial Pancreas) During Exercise in Adults With Type 1 Diabetes
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
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-
Quebec
-
Montreal, Quebec, Kanada, H2W 1R7
- Institut de recherches cliniques de Montréal
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: Single-hormone closed-loop system
In single-hormone closed-loop system, variable subcutaneous insulin infusion rate will be used to regulate glucose levels
|
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.
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.
|
|
Active Comparator: 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
|
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.
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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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The number of patients experiencing exercise-induced hypoglycemia requiring dextrose infusion (< 3.3 mmol/L symptomatic or < 3.0 mmol/L regardless of symptoms).
Aikaikkuna: 18:00 hours to 19:30 hours
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18:00 hours to 19:30 hours
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Decrease in glucose levels during each exercise
Aikaikkuna: 18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed
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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).
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18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed
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Area under the curve of plasma glucose levels < 4 mmol/L
Aikaikkuna: 15:30 hours to 19:30 hours
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15:30 hours to 19:30 hours
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|
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Percentage of time of plasma glucose levels < 4 mmol/L
Aikaikkuna: 15:30 hours to 19:30 hours
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15:30 hours to 19:30 hours
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Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Aikaikkuna: 15:30 hours to 19:30 hours
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15:30 hours to 19:30 hours
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Decremental area under the curve from the start of the exercise for 90 minutes.
Aikaikkuna: 18:00 to 19:30
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18:00 to 19:30
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Percentage of time-in-target defined as between 4 and 10 mmol/L
Aikaikkuna: 15:30 hours to 19:30 hours
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15:30 hours to 19:30 hours
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Mean time (minutes) to the first hypoglycemic event during the exercise period
Aikaikkuna: 18:00 to 19:00
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18:00 to 19:00
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The amount of dextrose infused
Aikaikkuna: 15:30 to 19:30
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15:30 to 19:30
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Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
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Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- CLASS-06
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