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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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| 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 |
|---|---|---|---|---|
| 12-day intervention with sensor-augmented pump therapy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of glucose levels spent between 3.9 and 10 mmol/L. | 288 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L | 288 hours | |
| Percentage of time of glucose levels spent below 3.9 mmol/L | 288 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 | 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 | ||
| McGill University Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33050728 | Derived | Haidar A, Legault L, Raffray M, Gouchie-Provencher N, Jacobs PG, El-Fathi A, Rutkowski J, Messier V, Rabasa-Lhoret R. Comparison Between Closed-Loop Insulin Delivery System (the Artificial Pancreas) and Sensor-Augmented Pump Therapy: A Randomized-Controlled Crossover Trial. Diabetes Technol Ther. 2021 Mar;23(3):168-174. doi: 10.1089/dia.2020.0365. Epub 2020 Dec 31. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 9, 2022 | |
| Reset | Apr 13, 2022 | |
| Release | May 5, 2022 |
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|
| 12-day intervention with single-hormone closed-loop strategy | 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 | Device | Tandem Diabetes Care |
|
| Continuous glucose monitoring system | Device | Dexcom G5 Platinum |
|
| Insulin | Drug | Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra) |
|
| 288 hours |
| Percentage of time of glucose levels spent below 2.8 mmol/L | 288 hours |
| Percentage of time of glucose levels spent above 10.0 mmol/L | 288 hours |
| Percentage of time of glucose levels spent above 13.9 mmol/L | 288 hours |
| Percentage of time of glucose levels spent above 16.7 mmol/L | 288 hours |
| Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L | The overnight period is between 00:00 and 06:00 | 72 hours |
| Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L | The overnight period is between 00:00 and 06:00 | 72 hours |
| Percentage of time of overnight glucose levels spent below 3.9 mmol/L | The overnight period is between 00:00 and 06:00 | 72 hours |
| Percentage of time of overnight glucose levels spent below 3.3 mmol/L | The overnight period is between 00:00 and 06:00 | 72 hours |
| Percentage of time of overnight glucose levels spent below 2.8 mmol/L | The overnight period is between 00:00 and 06:00 | 72 hours |
| Percentage of time of overnight glucose levels spent above 10.0 mmol/L | The overnight period is between 00:00 and 06:00 | 72 hours |
| Percentage of time of overnight glucose levels spent above 13.9 mmol/L | The overnight period is between 00:00 and 06:00 | 72 hours |
| Percentage of time of overnight glucose levels spent above 16.7 mmol/L | The overnight period is between 00:00 and 06:00 | 72 hours |
| Total number of hypoglycemic events below 3.1 mmol/L | 288 hours |
| Number of nights with hypoglycemic events below 3.1 mmol/L | 72 hours |
| Number of days with hypoglycemic events below 3.1 mmol/L | 126 hours |
| Mean glucose levels | 288 hours |
| Standard deviation of glucose levels | 288 hours |
| Time between failures due to glucose sensor unavailability | 288 hours |
| Coefficient of variation of glucose levels | 288 hours |
| Between-day variability in glucose levels | 288 hours |
| Total daily insulin dose | 24 hours |
| Standard deviation of insulin delivery | 288 hours |
| Coefficient of variation of insulin delivery | 288 hours |
| Between-day variability in insulin delivery | 288 hours |
| Total number of hours of glucose sensor availability | 288 hours |
| Percentage of time of glucose sensor availability | 288 hours |
| Time between failures due to pump connectivity | 288 hours |
| Percentage of time when patients switched back to insulin pump therapy | 288 hours |
| Number of hours when patients switched back to insulin pump therapy | 288 hours |
| Percentage of time when the closed-loop was automatically switched to insulin pump therapy | 288 hours |
| Number of hours when the closed-loop was automatically switched to insulin pump therapy | 288 hours |
| Number of days with at least one technical problem | 288 hours |
| Number of calls for technical issues related to the closed-loop system | 288 hours |
| Number of patients calling for technical issues related to the closed-loop system | 288 hours |
| Montreal |
| Quebec |
| H4A 3J1 |
| Canada |
| Reset | Feb 2, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 9, 2022 | Apr 13, 2022 | |||
| May 5, 2022 | Feb 2, 2023 |
| 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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