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| Name | Class |
|---|---|
| McGill University | OTHER |
| Montreal Children's Hospital of the MUHC | OTHER |
| Diabetes Québec | OTHER |
| Medtronic Minimed |
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Recent developments of continuous glucose sensors and insulin infusion pumps have motivated the research toward closed-loop strategies to regulate glucose levels in patients with type 1 diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based on a computer-generated recommendation that relies on continuous glucose sensor readings. In this study, we aim to compare the effectiveness of dual-hormone (insulin+glucagon) closed-loop strategy to open-loop conventional continuous subcutaneous insulin infusion pump (CSII) therapy in regulating glucose levels during an evening exercise and on a night following an exercise in adults with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-loop | Placebo Comparator | Conventional continuous subcutaneous insulin infusion (CSII) therapy |
|
| Dual-hormone closed-loop | Experimental | Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. The infusion rates are based on continuous glucose sensor reading and a control algorithm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional continuous subcutaneous insulin infusion therapy | Device |
| ||
| Dual-hormone closed-loop |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of plasma glucose concentrations spent in target range (4.0-10.0 mmol/l from 4:00p.m.-11:00p.m. and 4.0-8.0 mmol/l from 11:00p.m.-7:00a.m.) | 4 p.m. - 7 a.m. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of plasma glucose concentrations spent in the low range (< 4.0 mmol/l). | 4 p.m. - 7 a.m. | |
| Percentage of time of plasma glucose concentrations spent in the high range (>10.0 mmol/l from 4:00p.m.-11:00 p.m. and >8.0 mmol/l from 11:00 p.m.-7:00 a.m.). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rémi Rabasa-Lhoret, M.D., Ph.D. | Institut de Recherches Cliniques de Montréal (IRCM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Recherches Cliniques de Montréal (IRCM) | Montreal | Quebec | H2W 1R7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32345707 | Derived | Heyland DK, Heyland R, Bailey A, Howard M. A novel decision aid to help plan for serious illness: a multisite randomized trial. CMAJ Open. 2020 Apr 28;8(2):E289-E296. doi: 10.9778/cmajo.20190179. Print 2020 Apr-Jun. | |
| 23359039 | Derived | Haidar A, Legault L, Dallaire M, Alkhateeb A, Coriati A, Messier V, Cheng P, Millette M, Boulet B, Rabasa-Lhoret R. Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial. CMAJ. 2013 Mar 5;185(4):297-305. doi: 10.1503/cmaj.121265. Epub 2013 Jan 28. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| UNKNOWN |
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| Device |
|
| 4 p.m. - 7 a.m |
| Percentage of overnight time of plasma glucose concentrations spent in target range (4.0 - 8.0 mmol/l). | 11 p.m. - 7 a.m. |
| Percentage of overnight time of plasma glucose concentrations spent in the low range ( < 4.0 mmol/l). | 11 p.m. - 7 a.m. |
| Percentage of overnight time of plasma glucose concentrations spent in the high range (above 8 mmol/l). | 11 p.m. - 7 a.m. |
| Total insulin delivery. | 4 p.m. - 7 a.m. |
| Total overnight insulin delivery (11 p.m. - 7 a.m.). | 11 p.m. - 7 a.m. |
| Standard deviation and/or MAGE (Mean Amplitude of Glycemic Excursions) index of plasma glucose concentrations as measures of glucose variability. | 4 p.m. - 7 a.m. |
| Number of subjects with at least one plasma glucose measurement less than 3.9 mmol/l. | 4 p.m. - 7 a.m. |
| Number of subjects with at least one overnight plasma glucose measurement less than 3.9 mmol/l. | 11 p.m. - 7 a.m |
| Number of subjects with at least one exercise-induced plasma glucose measurement less than 3.9 mmol/l. | 5:50 p.m. - 7:20 p.m |
| Number of subjects with as at least one plasma glucose measurement below 3.3 mmol/l. | 4 p.m. - 7 a.m. |
| Number of subjects with at least one overnight plasma glucose measurement below 3.3 mmol/l. | 11 p.m. - 7 a.m |
| Number of subjects with at least one exercise-induced plasma glucose measurement below 3.3 mmol/l. | 5:50 p.m. - 7:20 p.m |
| Number of subjects with as at least one plasma glucose measurement below 3.0 mmol/l. | 4 p.m. - 7 a.m. |
| Number of subjects with at least one overnight plasma glucose measurement below 3.0 mmol/l. | 11 p.m. - 7 a.m |
| Number of subjects with at least one exercise-induced plasma glucose measurement below 3.0 mmol/l. | 5:50 p.m. - 7:20 p.m |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |