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
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≤ 10%.
- •Live in the area of Montreal.
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)
- •Pregnancy (ongoing or current attempt to become pregnant).
- •Severe hypoglycemic episode within two weeks of screening.
- •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.
- •Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
Arms & Interventions
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.
Intervention: 5-day intervention with sensor-augmented pump therapy (Other)
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.
Intervention: Insulin pump (Device)
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.
Intervention: Continuous glucose monitoring system (Device)
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.
Intervention: Insulin (Drug)
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.
Intervention: 5-day intervention with single-hormone closed-loop strategy (Other)
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.
Intervention: Insulin pump (Device)
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.
Intervention: Continuous glucose monitoring system (Device)
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.
Intervention: Insulin (Drug)
Outcomes
Primary Outcomes
Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L
Time Frame: 120 hours
Secondary Outcomes
- Percentage of time of overnight glucose levels spent below 2.8 mmol/L(35 hours)
- Percentage of time of overnight glucose levels spent above 10 mmol/L(35 hours)
- Percentage of time of overnight glucose levels spent above 13.9 mmol/L(35 hours)
- Percentage of time of overnight glucose levels spent above 16.7 mmol/L(35 hours)
- Area under the curve of glucose levels below 3.9 mmol/L(120 hours)
- Area under the curve of glucose levels below 3.3 mmol/L(120 hours)
- Area under the curve of glucose levels below 2.8 mmol/L(120 hours)
- Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L(120 hours)
- Percentage of time of glucose levels spent below 3.9 mmol/L(120 hours)
- Percentage of time of glucose levels spent below 3.3 mmol/L(120 hours)
- Percentage of time of glucose levels spent below 2.8 mmol/L(120 hours)
- Percentage of time of glucose levels spent above 10 mmol/L(120 hours)
- Percentage of time of glucose levels spent above 13.9 mmol/L(120 hours)
- Percentage of time of glucose levels spent above 16.7 mmol/L(120 hours)
- Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L(35 hours)
- Percentage of time of overnight glucose levels spent below 3.3 mmol/L(35 hours)
- Percentage of time of overnight glucose levels spent below 3.9 mmol/L(35 hours)
- Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L(35 hours)
- Area under the curve of glucose levels above 10 mmol/L(120 hours)
- Area under the curve of glucose levels above 13.9 mmol/L(120 hours)
- Area under the curve of glucose levels above 16.7 mmol/L(120 hours)
- Area under the curve of overnight glucose levels below 3.9 mmol/L(35 hours)
- Area under the curve of overnight glucose levels below 3.3 mmol/L(35 hours)
- Area under the curve of overnight glucose levels below 2.8 mmol/L(35 hours)
- Area under the curve of overnight glucose levels above 10 mmol/L(35 hours)
- Area under the curve of overnight glucose levels above 13.9 mmol/L(35 hours)
- Area under the curve of overnight glucose levels above 16.7 mmol/L(35 hours)
- Mean glucose levels(120 hours)
- Standard deviation of glucose levels(120 hours)
- Standard deviation of insulin delivery(120 hours)
- Coefficient of variance of glucose levels(120 hours)
- Coefficient of variance of insulin delivery(120 hours)
- Between-day variability in glucose levels(120 hours)
- Between-day variability in insulin delivery(120 hours)
- Total insulin delivery(120 hours)
- Percentage of time of closed-loop operation(120 hours)
- Percentage of time of glucose sensor availability(120 hours)
- Time between failures(120 hours)
- Number of hypoglycemic events less than 3.1 mmol/L(120 hours)
- Number of nights with hypoglycemic events less than 3.1 mmol/L(35 hours)
- Number of days with hypoglycemic events less than 3.1 mmol/L(120 hours)
Investigators
Rémi Rabasa-Lhoret
Associate Professor of Medicine
Institut de Recherches Cliniques de Montreal