We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Simplification of CF-related Diabetes Screening at Home (AtHome)

This study is not yet open for participant recruitment.
Verified July 2017 by Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
Sponsor:
ClinicalTrials.gov Identifier:
NCT03227094
First Posted: July 24, 2017
Last Update Posted: July 24, 2017
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.
Collaborators:
Université de Montréal
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
  Purpose

Cystic fibrosis (CF)-related diabetes (CFRD) is the most common complication after pulmonary complications. This specific form of diabetes is associated with an increased morbidity and mortality. CFRD prevalence at the age of 10 is 10% and reaches 40 to 50% in adulthood, while another 35% of adult patients presents impaired glucose tolerance.

In order to identify patients at risk and to implement early therapeutic measures, an annual CFRD screening test should therefore be undertaken for CF patients after 10 years of age. The 2-hour oral glucose tolerance test (OGTT) with a sweet beverage is the recommended screening test. However, participation rates for screening tests are far from optimal. For examples, in 2015, the investigators observed that only 47% of non-diabetic patients attended to planned screening despite large availability and advertisement (unpublished data). Comparable low levels of screening for CFRD, usually below 33%, have been reported by various teams. Several reasons could explain these low adherence rates. Some factors are related to patients perceptions and experience: OGTT is perceived as an additional medical burden requiring a scheduled appointment (several weeks after the last exacerbation); overnight fasting followed by the intake of a large glucose load within 5 minutes can lead to nausea, headache, bloating and fatigue; some patients fear multiple blood sampling, etc. In addition, in case of CFRD diagnosis, recommended capillary blood glucose monitoring, nutritional advice and treatment (insulin) are perceived as extremely invasive and complex, thus some patients prefer avoiding screening test. To date, no alternative screening method has demonstrated its effectiveness to screen for CFRD. The investigators of this study believe that a simplified version of the OGTT would be more attractive, would make it more acceptable for patients and has the potential to improve their adherence to screening tests, simplify CF-team works and reduce costs. By allowing appropriate education and introduction of treatment in a timely manner, improved adherence to annual screening for dysglycemia has the potential to minimize or prevent clinical deterioration observed in years preceding CFRD onset.


Condition Intervention
Cystic Fibrosis Cystic Fibrosis-related Diabetes Diagnostic Test: Standard OGTT Diagnostic Test: Home-based OGTT (Beverage) Diagnostic Test: Home-based OGTT (Candy)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Simplification of CF-related Diabetes Screening by the Use of a Home-based Oral Glucose Tolerance Test (OGTT): A Pilot Study to Evaluate the Validity and Patients' Perceptions

Resource links provided by NLM:


Further study details as provided by Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal:

Primary Outcome Measures:
  • Internal validity [ Time Frame: OGTTs performed within 14 days ]
    Specificity and sensitivity of both home-based OGTTs versus a standard OGTT in controlled setting

  • Predictive value (positive and negative) [ Time Frame: OGTTs performed within 14 days ]
    Both home-based OGTTs versus a standard OGTT in controlled setting


Secondary Outcome Measures:
  • Patient's perception [ Time Frame: OGTTs performed within 14 days ]
    Visual analog scale questionnaire

  • Cost evaluation of methods [ Time Frame: OGTTs performed within 14 days ]
    Estimated cost of each methods


Estimated Enrollment: 20
Anticipated Study Start Date: August 15, 2017
Estimated Study Completion Date: August 15, 2018
Estimated Primary Completion Date: June 15, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard OGTT
OGTT standard test at hospital (75g glucose beverage; 2-h test with plasma glucose collection)
Diagnostic Test: Standard OGTT
Standard-OGTT Plasma glucose : 0, 30, 60, 90, 120 minutes Complete biochemical profile, weight and size (body mass index), drugs list, pulmonary function by spirometry (FEV, etc.) Questionnaires CGMS training & delivery of Jelly-Bean/75g glucose beverage
Experimental: Home-based OGTT (Beverage)
Home-based OGTT with CGM device, without glucose collection (75g glucose beverage; 2-h test: glycemia measured by CGM)
Diagnostic Test: Home-based OGTT (Beverage)
In a random order Candy-OGTT (Jelly-Bean) or 75 g glucose beverage Glycemia every 15 minutes from CGMS collection; standardized condition (fasting + rest) Questionnaires
Experimental: Home-based OGTT (Candy)
Home-based OGTT with CGM device, without glucose collection (75g of glucose (Jelly Beans); 2-h test: glycemia measured by CGM)
Diagnostic Test: Home-based OGTT (Candy)
In a random order Candy-OGTT (Jelly-Bean) or 75 g glucose beverage Glycemia every 15 minutes from CGMS collection; standardized condition (fasting + rest) Questionnaires

Detailed Description:

The investigators propose a pilot study to evaluate the validity and the acceptability of a home-based OGTT by comparing, in patients with CF:

  • Standard hospital-based OGTT with measures of plasma glucose and the use of 75g glucose beverage;
  • Home-based OGTT with measures of glucose using a continuous glucose monitoring system (CGMS; without blood sample collection) and the 75g glucose beverage;
  • Home-based OGTT with measures of glucose using CGMS and 75g of glucose from candies as a substitute to this poorly appreciate beverage.

Specific objectives are to determine i) the internal validity (specificity, sensitivity) of both home-based OGTTs versus a standard OGTT in controlled setting, and ii) the predictive value (positive and negative). The investigators will also iii) investigate patient's perception and likelihood that the proposed method improves adherence to annual screening, and iv) evaluate potential cost reduction associated with proposed simplified screening tests.

On the day of the OGTT, and after obtaining informed consent, a CGMS will be installed. Patients will receive the very simple training required to use it as well as a pre-packed Jelly Beans bag containing 75g of glucose and a standard 75g glucose beverage bottle. This CGMS will provide interstitial glucose values each 15 min over the next 14 days.

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult CF-patient without known diabetes
  • In stable condition at least 1-month apart from the last exacerbation.

Exclusion Criteria:

  • Known CFRD
  • Recent exacerbation
  • Use medications known to interfere with glucose metabolism such as oral steroids.
  Contacts and Locations
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): NCT03227094


Contacts
Contact: Valérie Boudreau, PhD (c) 15149875500 ext 3238 valerie.boudreau@ircm.qc.ca
Contact: Katherine Desjardins, MSc 514-987-5581 katherine.desjardins@ircm.qc.ca

Locations
Canada, Quebec
Montreal Clinical Research Institute (IRCM) Not yet recruiting
Montréal, Quebec, Canada, H2W 1R7
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
Université de Montréal
Vertex Pharmaceuticals Incorporated
Investigators
Principal Investigator: Rémi Rabasa-Lhoret, MD, PhD Montreal Research Clinical Institute
  More Information

Responsible Party: Rémi Rabasa-Lhoret, Associate Professor of Medicine, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT03227094     History of Changes
Other Study ID Numbers: AtHome
First Submitted: July 18, 2017
First Posted: July 24, 2017
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal:
Diabetes
Screening test
Continuous glucose monitoring
Oral glucose tolerance test

Additional relevant MeSH terms:
Diabetes Mellitus
Fibrosis
Cystic Fibrosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases