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

Institut de Recherches Cliniques de Montreal

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes

Treatments: Other: 12-day intervention with sensor-augmented pump therapy; Other: 12-day intervention with single-hormone closed-loop strategy; Drug: Insulin; Device: Continuous glucose monitoring system; Device: Insulin pump

Study type: Interventional

Funder types: Other

Identifiers

NCT02846831

CLASS-14

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Sensor-augmented pump therapy

Active Comparator group

Description:

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.

Treatment:

Other: 12-day intervention with sensor-augmented pump therapy

Device: Insulin pump

Device: Continuous glucose monitoring system

Drug: Insulin

Single-hormone closed-loop strategy

Active Comparator group

Description:

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.

Treatment:

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

Device: Insulin pump

Device: Continuous glucose monitoring system

Drug: Insulin