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Closed-loop Control of Glucose Levels After Meal Intake in Adults With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT01930097
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : April 9, 2014
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Tracking Information
First Submitted Date  ICMJE August 23, 2013
First Posted Date  ICMJE August 28, 2013
Last Update Posted Date April 9, 2014
Study Start Date  ICMJE August 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
The positive incremental area under the curve of postprandial glucose excursions [ Time Frame: 4 hours after meal intake ]
The positive incremental area under the curve (IAUC, as compared to pre-meal glucose value) of the 4-hr postprandial glucose excursions for the breakfast, lunch and dinner meals.
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2013)
The incremental area under the curve of postprandial glucose excursions [ Time Frame: 4 hours after meal intake ]
The incremental area under the curve (IAUC, as compared to pre-meal glucose value) of the 4-hr postprandial glucose excursions for the breakfast, lunch and dinner meals.
Change History Complete list of historical versions of study NCT01930097 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
  • Mean plasma glucose [ Time Frame: 8h00 to 21h00 ]
  • Incremental two hours postprandial glucose [ Time Frame: 2 hours after meal intake ]
  • Incremental postprandial peak-glucose values [ Time Frame: 8h00 to 21h00 ]
  • Percentage of time of plasma glucose levels between 4.0 and 10.0 mmol/L [ Time Frame: 8h00 to 21h00 ]
  • Percentage of time of plasma glucose levels spent above 10.0 mmol/L [ Time Frame: 8h00 to 21h00 ]
  • Percentage of time of plasma glucose levels spent below 4.0 mmol/L [ Time Frame: 8h00 to 21h00 ]
  • Total insulin delivery [ Time Frame: 8h00 to 21h00 ]
  • Total glucagon delivery [ Time Frame: 8h00 to 21h00 ]
  • Standard deviation of glucose levels [ Time Frame: 8h00 to 21h00 ]
  • Percentage of time of plasma glucose concentrations below 3.5 mmol/L [ Time Frame: 8h00 to 21h00 ]
  • Percentage of time of plasma glucose concentrations above 14 mmol/L [ Time Frame: 8h00 to 21h00 ]
  • Mean plasma insulin concentration [ Time Frame: 8h00 to 21h00 ]
  • Mean plasma glucagon concentration [ Time Frame: 8h00 to 21h00 ]
  • Number of patients experiencing hypoglycemia requiring oral treatment [ Time Frame: 8h00 to 21h00 ]
  • Incremental area under the curve of the 4-hr postprandial glucose excursions but the reference glucose is set to 5.0 mmol/L if premeal glucose is less than 5.0 mmol/L. [ Time Frame: 4 hours after meal intake ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2013)
  • Mean plasma glucose [ Time Frame: 8h00 to 21h00 ]
  • Incremental two hours postprandial glucose [ Time Frame: 2 hours after meal intake ]
  • Incremental postprandial peak-glucose values [ Time Frame: 8h00 to 21h00 ]
  • Percentage of time of plasma glucose levels between 4.0 and 10.0 mmol/L [ Time Frame: 8h00 to 21h00 ]
  • Percentage of time of plasma glucose levels spent above 10.0 mmol/L [ Time Frame: 8h00 to 21h00 ]
  • Percentage of time of plasma glucose levels spent below 4.0 mmol/L [ Time Frame: 8h00 to 21h00 ]
  • Total insulin delivery [ Time Frame: 8h00 to 21h00 ]
  • Total glucagon delivery [ Time Frame: 8h00 to 21h00 ]
  • Standard deviation of glucose levels [ Time Frame: 8h00 to 21h00 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Closed-loop Control of Glucose Levels After Meal Intake in Adults With Type 1 Diabetes
Official Title  ICMJE An Open-label, Randomized, Three-way, Cross-over Study to Compare the Efficacy of Closed-loop Operation Combined With Meal-and-carbohydrate-announcement Closed-loop Operation Combined With Meal-announcement, and Conventional Pump Therapy in Regulating Glucose Levels in Adults With Type 1 Diabetes
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 objective 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.

Our primary hypothesis is that meal-announcement strategy (pre-meal CHO-independent bolus) is equivalent to meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) during closed-loop regulation of glucose levels in adults with T1D. Our secondary hypothesis is that closed-loop strategy with meal-announcement strategy (pre-meal CHO-independent bolus) or meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) is better than conventional pump treatment in regulation of glucose levels in adults with T1D.

Detailed Description

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. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.

Each patient will be admitted three times to a clinical research facility. In the meal-and-carbohydrate-announcement visit, patients will eat 3 meals 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 meal-announcement visit, patients will eat the 3 same meals 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. In the control visit, patients will use conventional pump therapy to regulate glucose levels.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE Other: 14 hours intervention
Subjects will be admitted at the IRCM at 6:30. Subjects will be asked to fast from midnight. At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served. At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served. At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served. Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc).
Study Arms  ICMJE
  • Active Comparator: CHO-dependant bolus

    An insulin bolus dependant of carbohydrate content will be given after each meal.

    Each subject insulin-to-carbohydrate ratio (U per 10g CHO) will be used to calculate the insulin bolus to be given. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings.

    Intervention: Other: 14 hours intervention
  • Active Comparator: CHO-independent bolus
    An insulin bolus independent of carbohydrate content will be given after each meal. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings.
    Intervention: Other: 14 hours intervention
  • Active Comparator: Conventional treatment
    Patients will use conventional pump therapy to regulate glucose levels
    Intervention: Other: 14 hours intervention
Publications * Gingras V, Rabasa-Lhoret R, Messier V, Ladouceur M, Legault L, Haidar A. Efficacy of dual-hormone artificial pancreas to alleviate the carbohydrate-counting burden of type 1 diabetes: A randomized crossover trial. Diabetes Metab. 2016 Feb;42(1):47-54. doi: 10.1016/j.diabet.2015.05.001. Epub 2015 Jun 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2013)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females ≥ 18 years of old.
  • Clinical diagnosis of type 1 diabetes for at least one year.
  • The subject will have been on insulin pump therapy for at least 3 months.
  • Last (less than 3 months) HbA1c ≤ 12%.

Exclusion Criteria:

  • Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
  • Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • Ongoing pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.
  • Medication likely to affect with the interpretation of the results because of their well known impact on gastric emptying: Motilium®, Prandase®, Victoza®, Byetta® and Symlin®.
  • Known or suspected allergy to the trial products, meal contents including nuts, peanuts, dairy products or eggs.
  • Unusual nutritional habits (e.g. vegetarians)
  • 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 or lack of insulin to carbohydrate ratios
  • Problems with venous access
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01930097
Other Study ID Numbers  ICMJE CLASS-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
Study Sponsor  ICMJE Institut de Recherches Cliniques de Montreal
Collaborators  ICMJE Juvenile Diabetes Research Foundation
Investigators  ICMJE
Principal Investigator: Rémi Rabasa-Lhoret, MD, PhD Institut de recherches cliniques de Montréal
PRS Account Institut de Recherches Cliniques de Montreal
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP