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Trial record 4 of 1485 for:    Type 1 Diabetes Mellitus 5

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 5 Days in Adults With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02488616
Recruitment Status : Withdrawn (Medtronic support terminated)
First Posted : July 2, 2015
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Brief Summary:

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.

The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy and sensor-augmented pump therapy to regulate glucose levels in outpatient settings for 5 consecutive days in adults with type 1 diabetes.

The investigators hypothesized that single-hormone closed-loop strategy will increase the time spent in the target range compared to sensor-augmented pump therapy.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: 5-day intervention with single-hormone closed-loop strategy Other: 5-day intervention with sensor-augmented pump therapy Device: Insulin pump Device: Continuous glucose monitoring system Drug: Insulin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy and Sensor-augmented Pump Therapy in Regulating Glucose Levels for 5 Days in Free-living Outpatient Conditions in Patients With Type 1 Diabetes
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sensor-augmented pump therapy
Participants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours.
Other: 5-day intervention with sensor-augmented pump therapy

A sensor will be inserted on the day prior to the first day of the intervention by the participants. The participant will also have to install the study insulin pump. Participants will be advised to continue with study intervention at home for the next 5 days.

Participants will have been previously shown how to use the study insulin pump.


Device: Insulin pump
MiniMed® Paradigm® Veo™, Medtronic

Device: Continuous glucose monitoring system
Enlite sensor®, Medtronic

Drug: Insulin
Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)

Active Comparator: Single-hormone closed-loop strategy
Variable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump.
Other: 5-day intervention with single-hormone closed-loop strategy

A sensor will be inserted on the day prior to the first day of the intervention by the participants. On the first day of the intervention, participants will be admitted to the clinical research facility anytime between 8:00 am and 11:30 am. Training on connection and disconnection of the system, meal boluses, etc. will be given.

Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be advised to continue with study intervention at home for the next 5 days.


Device: Insulin pump
MiniMed® Paradigm® Veo™, Medtronic

Device: Continuous glucose monitoring system
Enlite sensor®, Medtronic

Drug: Insulin
Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)




Primary Outcome Measures :
  1. Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L [ Time Frame: 120 hours ]

Secondary Outcome Measures :
  1. Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L [ Time Frame: 120 hours ]
  2. Percentage of time of glucose levels spent below 3.9 mmol/L [ Time Frame: 120 hours ]
  3. Percentage of time of glucose levels spent below 3.3 mmol/L [ Time Frame: 120 hours ]
  4. Percentage of time of glucose levels spent below 2.8 mmol/L [ Time Frame: 120 hours ]
  5. Percentage of time of glucose levels spent above 10 mmol/L [ Time Frame: 120 hours ]
  6. Percentage of time of glucose levels spent above 13.9 mmol/L [ Time Frame: 120 hours ]
  7. Percentage of time of glucose levels spent above 16.7 mmol/L [ Time Frame: 120 hours ]
  8. Percentage of time of overnight glucose levels spent below 3.9 mmol/L [ Time Frame: 35 hours ]
  9. Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L [ Time Frame: 35 hours ]
  10. Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L [ Time Frame: 35 hours ]
  11. Percentage of time of overnight glucose levels spent below 3.3 mmol/L [ Time Frame: 35 hours ]
  12. Percentage of time of overnight glucose levels spent below 2.8 mmol/L [ Time Frame: 35 hours ]
  13. Percentage of time of overnight glucose levels spent above 10 mmol/L [ Time Frame: 35 hours ]
  14. Percentage of time of overnight glucose levels spent above 13.9 mmol/L [ Time Frame: 35 hours ]
  15. Percentage of time of overnight glucose levels spent above 16.7 mmol/L [ Time Frame: 35 hours ]
  16. Area under the curve of glucose levels below 3.9 mmol/L [ Time Frame: 120 hours ]
  17. Area under the curve of glucose levels below 3.3 mmol/L [ Time Frame: 120 hours ]
  18. Area under the curve of glucose levels below 2.8 mmol/L [ Time Frame: 120 hours ]
  19. Area under the curve of glucose levels above 10 mmol/L [ Time Frame: 120 hours ]
  20. Area under the curve of glucose levels above 13.9 mmol/L [ Time Frame: 120 hours ]
  21. Area under the curve of glucose levels above 16.7 mmol/L [ Time Frame: 120 hours ]
  22. Area under the curve of overnight glucose levels below 3.9 mmol/L [ Time Frame: 35 hours ]
  23. Area under the curve of overnight glucose levels below 3.3 mmol/L [ Time Frame: 35 hours ]
  24. Area under the curve of overnight glucose levels below 2.8 mmol/L [ Time Frame: 35 hours ]
  25. Area under the curve of overnight glucose levels above 10 mmol/L [ Time Frame: 35 hours ]
  26. Area under the curve of overnight glucose levels above 13.9 mmol/L [ Time Frame: 35 hours ]
  27. Area under the curve of overnight glucose levels above 16.7 mmol/L [ Time Frame: 35 hours ]
  28. Mean glucose levels [ Time Frame: 120 hours ]
  29. Standard deviation of glucose levels [ Time Frame: 120 hours ]
  30. Standard deviation of insulin delivery [ Time Frame: 120 hours ]
  31. Coefficient of variance of glucose levels [ Time Frame: 120 hours ]
  32. Coefficient of variance of insulin delivery [ Time Frame: 120 hours ]
  33. Between-day variability in glucose levels [ Time Frame: 120 hours ]
  34. Between-day variability in insulin delivery [ Time Frame: 120 hours ]
  35. Total insulin delivery [ Time Frame: 120 hours ]
  36. Percentage of time of closed-loop operation [ Time Frame: 120 hours ]
  37. Percentage of time of glucose sensor availability [ Time Frame: 120 hours ]
  38. Time between failures [ Time Frame: 120 hours ]
    Total hours of closed-loop operation over number of failures

  39. Number of hypoglycemic events less than 3.1 mmol/L [ Time Frame: 120 hours ]
  40. Number of nights with hypoglycemic events less than 3.1 mmol/L [ Time Frame: 35 hours ]
  41. Number of days with hypoglycemic events less than 3.1 mmol/L [ Time Frame: 120 hours ]


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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. HbA1c ≤ 10%.
  5. Live in the area of Montreal.

Exclusion Criteria:

  1. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  2. Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  3. Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
  4. Pregnancy (ongoing or current attempt to become pregnant).
  5. Severe hypoglycemic episode within two weeks of screening.
  6. Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
  7. Known or suspected allergy to the trial products
  8. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  9. Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).

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): NCT02488616


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, MD, PhD Institut de recherches cliniques de Montréal

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Responsible Party: Rémi Rabasa-Lhoret, Associate Professor of Medicine, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT02488616     History of Changes
Other Study ID Numbers: CLASS-11
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal:
Closed-loop system
Artificial pancreas
Type 1 diabetes
Hypoglycemia
Insulin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hormones
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists