Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 748 for:    Area Under Curve AND meal

Safety and Efficacy of Artificial Pancreas With and Without a Meal Detection Module on Glycemic Control in Adolescents With Type 1 Diabetes After a Missed Bolus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02909829
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmad Haidar, McGill University

Brief Summary:

Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a good range is a difficult task. A primary source for poor glucose control in adolescents is skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the research towards closed-loop delivery systems to automatically regulate glucose levels. Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings. The performance of a closed-loop delivery after a missed bolus may be improved if the computer program that calculates the insulin is enhanced with a meal detection module. The meal detection module will automatically detect the meal (which had no bolus delivered), and signal the delivery of more insulin.

The aim of this study is to assess the safety and efficacy of a closed-loop delivery with and without meal detection module compared to conventional pump therapy in regulating post-prandial glycemic levels after omission of a meal bolus.

The primary hypothesis is that closed-loop delivery with no meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Closed Loop Delivery Device: Closed Loop Delivery with Meal Detection Module Device: Conventional Pump Therapy Not Applicable

Detailed Description:

Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a good range is a difficult task. A primary source for poor glucose control in adolescents is skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the research towards closed-loop delivery systems to automatically regulate glucose levels. Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings. The performance of a closed-loop delivery after a missed bolus may be improved if the computer program that calculates the insulin is enhanced with a meal detection module. The meal detection module will automatically detect the meal (which had no bolus delivered), and signal the delivery of more insulin.

The aim of this study is to conduct a randomized, three-way, cross-over trial to compare the efficacy of closed-loop delivery, closed-loop delivery with a meal detection module, and conventional pump therapy. The study aims to compare these three interventions for 9 hours in adolescents with poorly controlled type 1 diabetes.

Each 9 hours will include two meals of different carbohydrate content, of which one will not have a carbohydrate-matched prandial bolus. This study will allow for the assessment of the safety and efficacy of closed-loop delivery with and without a meal detection module compared to conventional pump therapy in regulating post-prandial glycaemia.

The aim of this study is to assess the safety and efficacy of a closed-loop delivery with and without meal detection module compared to conventional pump therapy in regulating post-prandial glycemic levels after omission of a meal bolus.

The primary hypothesis is that closed-loop delivery with no meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.

The secondary hypotheses are:

  1. Closed-loop delivery with meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.
  2. Closed-loop delivery with meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to closed-loop delivery with no meal detection module.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Three-way, Crossover Study to Assess the Safety and Efficacy of Closed-loop Delivery With and Without Meal Detection Module and Conventional Pump Therapy in Regulating Glucose Levels After a Missed Bolus in Adolescents With Type 1 Diabetes in Inpatient Settings
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Closed Loop Delivery
Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm. Participants will eat breakfast and bolus, then eat lunch and not bolus.
Device: Closed Loop Delivery
Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm.

Experimental: Closed Loop Delivery with Meal Detection Module
Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm with an overlying meal detection module which detects missed meals and will increase insulin infusion rates based on a predictive meal detection algorithm. Participants will eat breakfast and bolus, then eat lunch and not bolus.
Device: Closed Loop Delivery with Meal Detection Module
Closed Loop Delivery with Meal Detection Module Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm with an overlying meal detection module which detects missed meals and will increase insulin infusion rates based on a predictive meal detection algorithm

Active Comparator: Conventional Pump Therapy
Insulin will be delivered by subcutaneous insulin infusion pump with participants usual infusion rate. Participants will eat breakfast and bolus as per usual, then eat lunch and not bolus.
Device: Conventional Pump Therapy
Insulin will be delivered by subcutaneous insulin infusion pump with participants usual infusion rate




Primary Outcome Measures :
  1. AUCinc: The incremental area under the curve (as compared to pre-meal glucose value) of the postprandial glucose excursions for the lunch meal. [ Time Frame: 0 - 240 min postprandial lunch meal ]

Secondary Outcome Measures :
  1. AUCinc: The incremental area under the curve (as compared to pre-meal glucose value) of the postprandial glucose excursions: a. >10.0 mmol/L; b. >13.9 mmol/L; c. >16.7 mmol/L [ Time Frame: 0 - 240 min postprandial lunch meal ]
  2. Percentage of postprandial time of sensor glucose measurements spent: a. <3.9 mmol/L; b. between 3.9 and 7.8 mmol/L; c. between 3.9 and 10.0 mmol/L; d. >10.0 mmol/L; e. >13.9 mmol/L; f. >16.7 mmol/L. [ Time Frame: 0 - 240 min postprandial lunch meal ]
  3. Mean sensor glucose concentration. [ Time Frame: 9 hours ]
  4. Total insulin delivery [ Time Frame: 9 hours ]
  5. Glucose concentration as measured by CGM at 2 hours (120 min) post-meal. [ Time Frame: 120 min postprandial lunch meal ]
  6. Incremental glucose concentration as measured by CGM at 2 hours (120 min) post-meal. [ Time Frame: 120 min postprandial lunch meal ]
  7. Incremental postprandial peak of glucose concentration as measured by CGM. [ Time Frame: 0 - 240 min postprandial lunch meal ]
  8. Number of hyperglycemic events > 18.0mmol/L. [ Time Frame: 0 - 240 min postprandial lunch meal ]
  9. 1. Glucose concentration as measured by CGM at 5 hours (300 min) post-meal. Glucose concentration as measured by CGM at 5 hours (300 min) post-meal [ Time Frame: 300 min postprandial lunch meal ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of type 1 diabetes for at least 12 months. (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
  2. The participant will have been on insulin pump therapy for at least 3 months.
  3. HbA1c 7.5% to 12%.
  4. Self-reported or documented history of missed-bolus for meals during the previous 6 months.

Exclusion Criteria:

  1. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  2. Severe hypoglycemic episode within one month of screening.
  3. Pregnancy.
  4. Current use of oral glucocorticoid medication (except low stable dose). Stable doses of inhaled steroids are acceptable.
  5. Known or suspected allergy to the trial products, including the meal content.
  6. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  7. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909829


Contacts
Layout table for location contacts
Contact: Ahmad Haidar, Eng., PhD. 514-398-4491 ahmad.haidar@mcgill.ca
Contact: Emilie Palisaitis 514-609-8961 emilie.palisaitis@mail.mcgill.ca

Locations
Layout table for location information
Canada, Quebec
McGill University Health Centre Recruiting
Montréal, Quebec, Canada
Contact: Emilie Palisaitis    514-609-8961    emilie.palisaitis@mail.mcgill.ca   
Sub-Investigator: Ahmad Haidar         
Principal Investigator: Legault Laurent         
Sponsors and Collaborators
McGill University

Layout table for additonal information
Responsible Party: Ahmad Haidar, Assistant Professor, McGill University
ClinicalTrials.gov Identifier: NCT02909829     History of Changes
Other Study ID Numbers: Missed Bolus 9h
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmad Haidar, McGill University:
Diabetes Mellitus, Type 1
Artificial Pancreas
Closed-Loop Delivery
Insulin
Adolescent
Missed Bolus
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs