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

8 februari 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

37

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Unannounced exercise
The target blood glucose of the algorithm will be as usual. A pre-meal full insulin bolus will be given.
Geneesmiddel: Insuline
De gebruikelijke snelwerkende insuline-analoog van de patiënt zal worden gebruikt.
Apparaat: Dexcom G4 Platinum-glucosesensor
De Dexcom G4 Platinum-glucosesensor wordt gebruikt om glucosespiegels te meten.
Ander: 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.
Apparaat: Insulin pump
Patient's insulin pump will be used to infuse insulin.
Ander: 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.
Actieve vergelijker: 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
Geneesmiddel: Insuline
De gebruikelijke snelwerkende insuline-analoog van de patiënt zal worden gebruikt.
Apparaat: Dexcom G4 Platinum-glucosesensor
De Dexcom G4 Platinum-glucosesensor wordt gebruikt om glucosespiegels te meten.
Ander: 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.
Apparaat: Insulin pump
Patient's insulin pump will be used to infuse insulin.
Ander: 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.
Actieve vergelijker: 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%.
Geneesmiddel: Insuline
De gebruikelijke snelwerkende insuline-analoog van de patiënt zal worden gebruikt.
Apparaat: Dexcom G4 Platinum-glucosesensor
De Dexcom G4 Platinum-glucosesensor wordt gebruikt om glucosespiegels te meten.
Ander: 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.
Apparaat: Insulin pump
Patient's insulin pump will be used to infuse insulin.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Relative decrease in glucose levels during exercise compared to pre-breakfast levels
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: From 9:30 to 10:30 (60 minutes)
From 9:30 to 10:30 (60 minutes)
Mean plasma glucose levels
Tijdsspanne: From 8:00 to 11:30 (210 minutes)
From 8:00 to 11:30 (210 minutes)
Standard deviation of glucose levels
Tijdsspanne: From 8:00 to 11:30 (210 minutes)
From 8:00 to 11:30 (210 minutes)
Coefficient of variation of glucose levels
Tijdsspanne: From 8:00 to 11:30 (210 minutes)
From 8:00 to 11:30 (210 minutes)
Mean time (minutes) to the first hypoglycemic event
Tijdsspanne: From 9:30 to 10:30 (60 minutes)
From 9:30 to 10:30 (60 minutes)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Institut de Recherches Cliniques de Montreal

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2016

Primaire voltooiing (Werkelijk)

1 december 2018

Studie voltooiing (Werkelijk)

1 december 2018

Studieregistratiedata

Eerst ingediend

1 augustus 2016

Eerst ingediend dat voldeed aan de QC-criteria

1 augustus 2016

Eerst geplaatst (Schatting)

4 augustus 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 februari 2019

Laatste update ingediend die voldeed aan QC-criteria

8 februari 2019

Laatst geverifieerd

1 februari 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CLASS-16

Plan Individuele Deelnemersgegevens (IPD)

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