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

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ClinicalTrials.gov Identifier: NCT02855307
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: 60-minute exercise Device: Insulin pump Device: Dexcom G4 Platinum glucose sensor Drug: Insulin Other: Single-hormone closed-loop strategy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Unannounced exercise
The target blood glucose of the algorithm will be as usual. A pre-meal full insulin bolus will be given.
Other: 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.

Device: Insulin pump
Patient's insulin pump will be used to infuse insulin.

Device: Dexcom G4 Platinum glucose sensor
The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.

Drug: Insulin
Patient's usual fast-acting insulin analog will be used.

Other: 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.

Active Comparator: 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
Other: 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.

Device: Insulin pump
Patient's insulin pump will be used to infuse insulin.

Device: Dexcom G4 Platinum glucose sensor
The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.

Drug: Insulin
Patient's usual fast-acting insulin analog will be used.

Other: 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.

Active Comparator: 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%.
Other: 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.

Device: Insulin pump
Patient's insulin pump will be used to infuse insulin.

Device: Dexcom G4 Platinum glucose sensor
The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.

Drug: Insulin
Patient's usual fast-acting insulin analog will be used.

Other: 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.




Primary Outcome Measures :
  1. Percentage of time of plasma glucose levels spent below 3.9 mmol/L [ Time Frame: From 9:30 to 11:30 (120 minutes) ]

Secondary Outcome Measures :
  1. Relative decrease in glucose levels during exercise compared to pre-breakfast levels [ Time Frame: 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

  2. Number of patients experiencing exercise-induced hypoglycemia requiring treatment [ Time Frame: From 9:30 to 10:30 (60 minutes) ]
  3. Decremental area under the curve from the start of the exercise [ Time Frame: From 9:30 to 11:00 (90 minutes) ]
  4. Percentage of time of plasma glucose levels spent below 3.9 mmol/L [ Time Frame: From 9:30 to 10:30 (60 minutes) ]
  5. Percentage of time of plasma glucose levels spent below 3.3 mmol/L [ Time Frame: From 9:30 to 10:30 (60 minutes) ]
  6. Percentage of time of plasma glucose levels spent below 2.8 mmol/L [ Time Frame: From 9:30 to 10:30 (60 minutes) ]
  7. Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L [ Time Frame: From 9:30 to 10:30 (60 minutes) ]
  8. Percentage of time of plasma glucose levels spent above 10 mmol/L [ Time Frame: From 9:30 to 10:30 (60 minutes) ]
  9. Percentage of time of plasma glucose levels spent above 13.9 mmol/L [ Time Frame: From 9:30 to 10:30 (60 minutes) ]
  10. Percentage of time of plasma glucose levels spent above 16.7 mmol/L [ Time Frame: From 9:30 to 10:30 (60 minutes) ]
  11. Mean plasma glucose levels [ Time Frame: From 8:00 to 11:30 (210 minutes) ]
  12. Standard deviation of glucose levels [ Time Frame: From 8:00 to 11:30 (210 minutes) ]
  13. Coefficient of variation of glucose levels [ Time Frame: From 8:00 to 11:30 (210 minutes) ]
  14. Mean time (minutes) to the first hypoglycemic event [ Time Frame: From 9:30 to 10:30 (60 minutes) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855307


Locations
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Canada, Quebec
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
Investigators
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Principal Investigator: Rémi Rabasa-Lhoret Institut de recherches cliniques de Montréal

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Responsible Party: Rémi Rabasa-Lhoret, Professor of Medicine, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT02855307     History of Changes
Other Study ID Numbers: CLASS-16
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal:
Closed-loop system
Artificial pancreas
Exercise
Hypoglycemia
Insulin
Type 1 diabetes

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Pancrelipase
Pancreatin
Hormones
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents