Comparison of Closed-loop Operation After Morning Meal With and Without Carbohydrate Counting
NCT ID: NCT01519102
Last Updated: 2012-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2012-01-31
2012-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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CHO-independent partial insulin bolus with closed-loop
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.
CHO-dependent full insulin bolus combined with closed-loop
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* The subject will have been on insulin pump therapy for at least 3 months.
* Last (less than 3 months) HbA1c ≤ 12%.
Exclusion Criteria
* Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
* Pregnancy.
* Severe hypoglycemic episode within two weeks of screening.
• Medication likely to affect with the interpretation of the results: Prandase, Victoza, Byetta and Symlin
* 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.
* Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
* Unreliable carbohydrate counting
* Problems with venous access
18 Years
65 Years
ALL
No
Sponsors
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McGill University
OTHER
Montreal Children's Hospital of the MUHC
OTHER
Institut de Recherches Cliniques de Montreal
OTHER
Responsible Party
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Rémi Rabasa-Lhoret
Associate Professor of Medicine
Locations
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Institut de Recherches Cliniques de Montréal (IRCM)
Montreal, Quebec, Canada
Countries
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References
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Haidar A, Farid D, St-Yves A, Messier V, Chen V, Xing D, Brazeau AS, Duval C, Boulet B, Legault L, Rabasa-Lhoret R. Post-breakfast closed-loop glucose control is improved when accompanied with carbohydrate-matching bolus compared to weight-dependent bolus. Diabetes Metab. 2014 Jun;40(3):211-4. doi: 10.1016/j.diabet.2013.12.001. Epub 2014 Mar 19.
Other Identifiers
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CLASS-02
Identifier Type: -
Identifier Source: org_study_id