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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensor-augmented pump therapy | Active Comparator | 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. |
|
| Single-hormone closed-loop strategy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-day intervention with single-hormone closed-loop strategy | Other | A sensor will be inserted on the day prior to the first day 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. Competency on the use of study devices will be assessed by a team member. 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 5 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L | 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rémi Rabasa-Lhoret, MD, PhD | Institut de Recherches Cliniques de Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de recherches cliniques de Montréal | Montreal | Quebec | H2W 1R7 | Canada |
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| 5-day intervention with sensor-augmented pump therapy | Other | A sensor will be inserted on the day prior to the first day 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 5 days. Participants will have been previously shown how to use the study insulin pump. |
|
| Insulin pump | Device | MiniMed® Paradigm® Veo™, Medtronic |
|
| Continuous glucose monitoring system | Device | Enlite sensor®, Medtronic |
|
| Insulin | Drug | Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra) |
|
| 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 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 |
| 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 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 |
| 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 | Total hours of closed-loop operation over number of 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 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D007332 | Insulin Infusion Systems |
| D000095583 | Continuous Glucose Monitoring |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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