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Completed

NCT Number: NCT02846831

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 Days 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.

The objective of this study is to compare the effectiveness of single-hormone closed-loop and sensor-augmented pump therapy in regulating day-and-night glucose levels in adults with T1D for 12 days in outpatient settings.

The investigators hypothesize that dual-hormone closed-loop will increase the percentage of time of glucose levels spent in the target range in adults compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypoglycemia Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut de recherches cliniques de Montréal, Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • HbA1c ≤ 12%.

Exclusion criteria

  • Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
  • Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery
  • Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
  • Chronic use of acetaminophen. Acetaminophen may interfere with glucose sensor readings
  • Pregnancy (ongoing or current attempt to become pregnant)
  • Breastfeeding
  • No nearby party for assistance if needed
  • Plans to go abroad or travel at more than 2 hours distance from Montreal during the trial period
  • Severe hypoglycemic episode within two weeks of screening or during the run-in period
  • Severe hyperglycemic episode requiring hospitalization in the last 3 months
  • Current use of glucocorticoid medication (except low stable dose and inhaled steroids)
  • Known or suspected allergy to the trial products
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator
  • Anticipation of a significant change in exercise regimen between admission and end of the trial (i.e. starting or stopping an organized sport)

Treatment and study plan

12-day intervention with sensor-augmented pump therapy

Other

A sensor will be inserted on the day before the start 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 12 days.

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

12-day intervention with single-hormone closed-loop strategy

Other

A sensor will be inserted on the day before the start 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.

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 12 days.

Insulin pump

Device

Tandem Diabetes Care

Continuous Glucose Monitoring System

Device

Dexcom G5 Platinum

Insulin

Drug

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

Primary outcomes

  1. Percentage of time of glucose levels spent between 3.9 and 10 mmol/L.

    Time frame: 288 hours

Secondary outcomes

  1. Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L

    Time frame: 288 hours

  2. Percentage of time of glucose levels spent below 3.9 mmol/L

    Time frame: 288 hours

  3. Percentage of time of glucose levels spent below 3.3 mmol/L

    Time frame: 288 hours

  4. Percentage of time of glucose levels spent below 2.8 mmol/L

    Time frame: 288 hours

  5. Percentage of time of glucose levels spent above 10.0 mmol/L

    Time frame: 288 hours

  6. Percentage of time of glucose levels spent above 13.9 mmol/L

    Time frame: 288 hours

  7. Percentage of time of glucose levels spent above 16.7 mmol/L

    Time frame: 288 hours

  8. Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L

    Time frame: 72 hours

    The overnight period is between 00:00 and 06:00

  9. Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L

    Time frame: 72 hours

    The overnight period is between 00:00 and 06:00

  10. Percentage of time of overnight glucose levels spent below 3.9 mmol/L

    Time frame: 72 hours

    The overnight period is between 00:00 and 06:00

  11. Percentage of time of overnight glucose levels spent below 3.3 mmol/L

    Time frame: 72 hours

    The overnight period is between 00:00 and 06:00

  12. Percentage of time of overnight glucose levels spent below 2.8 mmol/L

    Time frame: 72 hours

    The overnight period is between 00:00 and 06:00

  13. Percentage of time of overnight glucose levels spent above 10.0 mmol/L

    Time frame: 72 hours

    The overnight period is between 00:00 and 06:00

  14. Percentage of time of overnight glucose levels spent above 13.9 mmol/L

    Time frame: 72 hours

    The overnight period is between 00:00 and 06:00

  15. Percentage of time of overnight glucose levels spent above 16.7 mmol/L

    Time frame: 72 hours

    The overnight period is between 00:00 and 06:00

  16. Total number of hypoglycemic events below 3.1 mmol/L

    Time frame: 288 hours

  17. Number of nights with hypoglycemic events below 3.1 mmol/L

    Time frame: 72 hours

  18. Number of days with hypoglycemic events below 3.1 mmol/L

    Time frame: 126 hours

  19. Mean glucose levels

    Time frame: 288 hours

  20. Standard deviation of glucose levels

    Time frame: 288 hours

  21. Time between failures due to glucose sensor unavailability

    Time frame: 288 hours

  22. Coefficient of variation of glucose levels

    Time frame: 288 hours

  23. Between-day variability in glucose levels

    Time frame: 288 hours

  24. Total daily insulin dose

    Time frame: 24 hours

  25. Standard deviation of insulin delivery

    Time frame: 288 hours

  26. Coefficient of variation of insulin delivery

    Time frame: 288 hours

  27. Between-day variability in insulin delivery

    Time frame: 288 hours

  28. Total number of hours of glucose sensor availability

    Time frame: 288 hours

  29. Percentage of time of glucose sensor availability

    Time frame: 288 hours

  30. Time between failures due to pump connectivity

    Time frame: 288 hours

  31. Percentage of time when patients switched back to insulin pump therapy

    Time frame: 288 hours

  32. Number of hours when patients switched back to insulin pump therapy

    Time frame: 288 hours

  33. Percentage of time when the closed-loop was automatically switched to insulin pump therapy

    Time frame: 288 hours

  34. Number of hours when the closed-loop was automatically switched to insulin pump therapy

    Time frame: 288 hours

  35. Number of days with at least one technical problem

    Time frame: 288 hours

  36. Number of calls for technical issues related to the closed-loop system

    Time frame: 288 hours

  37. Number of patients calling for technical issues related to the closed-loop system

    Time frame: 288 hours

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Official study 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 12 Days in Free-living Outpatient Conditions in Patients With Type 1 Diabetes

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2016
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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