Type 1 Diabetes
Conditions
Brief summary
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.
Interventions
DEVICEConventional continuous subcutaneous insulin infusion therapy
DEVICEDual-hormone closed-loop
Sponsors
McGill University
Montreal Children's Hospital of the MUHC
Diabetes Québec
Medtronic Minimed
Institut de Recherches Cliniques de Montreal
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of type 1 diabetes for at least one year. * On insulin pump therapy for at least 3 months. * HbA1c ≤ 10%.
Exclusion criteria
* Clinically significant nephropathy, neuropathy or retinopathy. * Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. * A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol. * Pregnancy. * Severe hypoglycemic episode within two weeks of screening. * Current use of glucocorticoid medication (by any route of administration except low dose stable inhaled). * Known or suspected allergy to the trial products or meal contents. * 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). * Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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.). | 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. |
| Percentage of time of plasma glucose concentrations spent in the low range (< 4.0 mmol/l). | 4 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 |
| Number of subjects with at least one overnight plasma glucose measurement less than 3.9 mmol/l. | 11 p.m. - 7 a.m |
Countries
Canada
Outcome results
None listed