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

8. Februar 2019 aktualisiert von: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

A Single-blind, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy at Preventing Hypoglycemia During Unannounced and Announced Exercise in Adults With Type 1 Diabetes

Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population.

The artificial pancreas 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. The artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored.

The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

37

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • Quebec
      • Montreal, Quebec, Kanada, H2W 1R7
        • Institut de Recherches Cliniques de Montréal

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  3. Use of medication with an effect on heart rate (e.g. beta-blockers).
  4. Abnormal blood panel and/or anemia.
  5. Ongoing or planned pregnancy.
  6. Severe hypoglycemic episode within two weeks of screening.
  7. 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).
  8. Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
  9. Problems with venous access.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Unannounced exercise
The target blood glucose of the algorithm will be as usual. A pre-meal full insulin bolus will be given.
Arzneimittel: Insulin
Es wird das übliche schnell wirkende Insulinanalogon des Patienten verwendet.
Gerät: Dexcom G4 Platinum Glukosesensor
Der Dexcom G4 Platinum-Glukosesensor wird zur Messung des Glukosespiegels verwendet.
Sonstiges: 60-minute exercise
Patients will be admitted at the research clinical facility at 6:30. The artificial pancreas intervention will start at 7:00. A standardized breakfast will be served at 8:00. At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max. At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served. Patients will be discharged after lunch consumption.
Gerät: Insulin pump
Patient's insulin pump will be used to infuse insulin.
Sonstiges: Single-hormone closed-loop strategy
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump. The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes. The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
Aktiver Komparator: Announced exercise with pre-meal full bolus
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
Arzneimittel: Insulin
Es wird das übliche schnell wirkende Insulinanalogon des Patienten verwendet.
Gerät: Dexcom G4 Platinum Glukosesensor
Der Dexcom G4 Platinum-Glukosesensor wird zur Messung des Glukosespiegels verwendet.
Sonstiges: 60-minute exercise
Patients will be admitted at the research clinical facility at 6:30. The artificial pancreas intervention will start at 7:00. A standardized breakfast will be served at 8:00. At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max. At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served. Patients will be discharged after lunch consumption.
Gerät: Insulin pump
Patient's insulin pump will be used to infuse insulin.
Sonstiges: Single-hormone closed-loop strategy
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump. The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes. The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
Aktiver Komparator: Announced exercise with reduced insulin bolus
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
Arzneimittel: Insulin
Es wird das übliche schnell wirkende Insulinanalogon des Patienten verwendet.
Gerät: Dexcom G4 Platinum Glukosesensor
Der Dexcom G4 Platinum-Glukosesensor wird zur Messung des Glukosespiegels verwendet.
Sonstiges: 60-minute exercise
Patients will be admitted at the research clinical facility at 6:30. The artificial pancreas intervention will start at 7:00. A standardized breakfast will be served at 8:00. At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max. At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served. Patients will be discharged after lunch consumption.
Gerät: Insulin pump
Patient's insulin pump will be used to infuse insulin.
Sonstiges: Single-hormone closed-loop strategy
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump. The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes. The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Zeitfenster: From 9:30 to 11:30 (120 minutes)
From 9:30 to 11:30 (120 minutes)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Relative decrease in glucose levels during exercise compared to pre-breakfast levels
Zeitfenster: From 8:00 to 10:50 (170 minutes)
Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until 20 minutes after exercise
From 8:00 to 10:50 (170 minutes)
Number of patients experiencing exercise-induced hypoglycemia requiring treatment
Zeitfenster: From 9:30 to 10:30 (60 minutes)
From 9:30 to 10:30 (60 minutes)
Decremental area under the curve from the start of the exercise
Zeitfenster: From 9:30 to 11:00 (90 minutes)
From 9:30 to 11:00 (90 minutes)
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Zeitfenster: From 9:30 to 10:30 (60 minutes)
From 9:30 to 10:30 (60 minutes)
Percentage of time of plasma glucose levels spent below 3.3 mmol/L
Zeitfenster: From 9:30 to 10:30 (60 minutes)
From 9:30 to 10:30 (60 minutes)
Percentage of time of plasma glucose levels spent below 2.8 mmol/L
Zeitfenster: From 9:30 to 10:30 (60 minutes)
From 9:30 to 10:30 (60 minutes)
Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L
Zeitfenster: From 9:30 to 10:30 (60 minutes)
From 9:30 to 10:30 (60 minutes)
Percentage of time of plasma glucose levels spent above 10 mmol/L
Zeitfenster: From 9:30 to 10:30 (60 minutes)
From 9:30 to 10:30 (60 minutes)
Percentage of time of plasma glucose levels spent above 13.9 mmol/L
Zeitfenster: From 9:30 to 10:30 (60 minutes)
From 9:30 to 10:30 (60 minutes)
Percentage of time of plasma glucose levels spent above 16.7 mmol/L
Zeitfenster: From 9:30 to 10:30 (60 minutes)
From 9:30 to 10:30 (60 minutes)
Mean plasma glucose levels
Zeitfenster: From 8:00 to 11:30 (210 minutes)
From 8:00 to 11:30 (210 minutes)
Standard deviation of glucose levels
Zeitfenster: From 8:00 to 11:30 (210 minutes)
From 8:00 to 11:30 (210 minutes)
Coefficient of variation of glucose levels
Zeitfenster: From 8:00 to 11:30 (210 minutes)
From 8:00 to 11:30 (210 minutes)
Mean time (minutes) to the first hypoglycemic event
Zeitfenster: From 9:30 to 10:30 (60 minutes)
From 9:30 to 10:30 (60 minutes)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Institut de Recherches Cliniques de Montreal

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2016

Primärer Abschluss (Tatsächlich)

1. Dezember 2018

Studienabschluss (Tatsächlich)

1. Dezember 2018

Studienanmeldedaten

Zuerst eingereicht

1. August 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. August 2016

Zuerst gepostet (Schätzen)

4. August 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Februar 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Februar 2019

Zuletzt verifiziert

1. Februar 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CLASS-16

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

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