CLASS02: Comparison of Closed-loop Operation After Morning Meal With and Without Carbohydrate Counting
Study Details
Study Description
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 dosage based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
The main goal of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D) without a significant degradation in post-meal glucose control.
Each patient will be admitted twice to a clinical research facility. In one visit, patients will eat a morning meal accompanied with a matching insulin bolus (depending on the carbohydrate content of the meal) and glucose levels will be subsequently regulated using dual-hormone closed-loop system. In the other visit, patients will eat the same meal but will inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and the remaining needed insulin will be delivered based on glucose sensor excursions as part of closed-loop operation. If post-meal glucose levels were indifferent between the two visits, then this would suggest that carbohydrate counting may not be necessary during closed-loop operation as the closed-loop system will give any remaining insulin needed to cover the glucose absorbed from the meal. Twelve subjects will be enrolled in this study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: CHO-independent partial insulin bolus with closed-loop
|
Device: Dual Hormone closed-loop system
The closed-loop system is composed of three components: continuous glucose system, insulin infusion pumps that infuses insulin and glucagon and a control algorithm that decides on the infusion rates based on sensor readings.
|
| Active Comparator: CHO-dependent full insulin bolus combined with closed-loop
|
Device: Dual Hormone closed-loop system
The closed-loop system is composed of three components: continuous glucose system, insulin infusion pumps that infuses insulin and glucagon and a control algorithm that decides on the infusion rates based on sensor readings.
|
Outcome Measures
Primary Outcome Measures
- Incremental area under the curve of plasma glucose concentration as compared to pre-meal glucose value of the postprandial glucose excursions [0-300min]
Secondary Outcome Measures
- Percentage of postprandial time of plasma glucose concentrations spent in the high range (above 10.0 mmol/l). [0-300 min]
- Mean plasma glucose concentration. []
- Total insulin delivery []
- Total glucagon delivery []
- Plasma glucose concentration and incremental plasma glucose concentration at 2 hours postmeal []
- Postprandial peak and incremental postprandial peak of plasma glucose concentration []
- Percentage of time of plasma glucose concentrations spent in target range. Target range is defined to be between 4.0 and 10.0 mmol/l for 150 minutes postmeal and between 4.0 and 8.0 mmol/l afterwards []
- Percentage of postprandial time of plasma glucose concentrations spent in the low range (below 4.0mmol/l) [0-300min]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males and females ≥ 18 and ≤ 65 years of old.
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Clinical diagnosis of type 1 diabetes for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment and medical history (e.g. history of acido-ketosis, etc.); C peptide level and antibody determinations are not needed.
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The subject will have been on insulin pump therapy for at least 3 months.
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Last (less than 3 months) HbA1c ≤ 12%.
Exclusion Criteria:
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Clinically significant nephropathy, neuropathy (especially clinically significant gastroparesis) or retinopathy as judged by the investigator.
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Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
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Pregnancy.
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Severe hypoglycemic episode within two weeks of screening.
• Medication likely to affect with the interpretation of the results: Prandase, Victoza, Byetta and Symlin
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Known or suspected allergy to the trial products or meal contents.
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Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
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Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
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Unreliable carbohydrate counting
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Problems with venous access
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut de Recherches Cliniques de Montréal (IRCM) | Montreal | Quebec | Canada | H2W 1R7 |
Sponsors and Collaborators
- Institut de Recherches Cliniques de Montreal
- McGill University
- Montreal Children's Hospital of the MUHC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLASS-02