Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 Days in Adults With Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-24

Study Completion Date

2020-01-27

Brief Summary

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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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Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

12-day intervention with sensor-augmented pump therapy

Intervention Type 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.

Insulin pump

Intervention Type DEVICE

Tandem Diabetes Care

Continuous glucose monitoring system

Intervention Type DEVICE

Dexcom G5 Platinum

Insulin

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Intervention Type DEVICE

Tandem Diabetes Care

Continuous glucose monitoring system

Intervention Type DEVICE

Dexcom G5 Platinum

Insulin

Intervention Type DRUG

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

Interventions

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12-day intervention with sensor-augmented pump therapy

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.

Intervention Type OTHER

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

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.

Intervention Type OTHER

Insulin pump

Tandem Diabetes Care

Intervention Type DEVICE

Continuous glucose monitoring system

Dexcom G5 Platinum

Intervention Type DEVICE

Insulin

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

Intervention Type DRUG

Eligibility Criteria

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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 ≤ 12%.

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. Chronic use of acetaminophen. Acetaminophen may interfere with glucose sensor readings
5. Pregnancy (ongoing or current attempt to become pregnant)
6. Breastfeeding
7. No nearby party for assistance if needed
8. Plans to go abroad or travel at more than 2 hours distance from Montreal during the trial period
9. Severe hypoglycemic episode within two weeks of screening or during the run-in period
10. Severe hyperglycemic episode requiring hospitalization in the last 3 months
11. Current use of glucocorticoid medication (except low stable dose and inhaled steroids)
12. Known or suspected allergy to the trial products
13. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator
14. Anticipation of a significant change in exercise regimen between admission and end of the trial (i.e. starting or stopping an organized sport)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No