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

Institut de Recherches Cliniques de Montreal

Status and phase: Withdrawn; Phase 2

Conditions: Type 1 Diabetes

Treatments: Other: 5-day intervention with single-hormone closed-loop strategy; Other: 5-day intervention with sensor-augmented pump therapy; Drug: Insulin; Device: Insulin pump; Device: Continuous glucose monitoring system

Study type: Interventional

Funder types: Other

Identifiers

NCT02488616

CLASS-11

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 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.

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 ≤ 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 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:

Drug: Insulin

Device: Insulin pump

Device: Continuous glucose monitoring system

Other: 5-day intervention with sensor-augmented pump therapy

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: 5-day intervention with single-hormone closed-loop strategy

Drug: Insulin

Device: Insulin pump

Device: Continuous glucose monitoring system