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

June 24, 2020 updated by: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

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

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that only 47% of non-diabetic patients attended to planned screening despite large availability and advertisement (unpublished data).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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2W1R7
        • CHUM
      • Montréal, Quebec, Canada, H2W 1R7
        • Montreal Clinical Research Institute (IRCM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal validity
Time Frame: OGTTs performed within 14 days
Specificity and sensitivity of both home-based OGTTs versus a standard OGTT in controlled setting
OGTTs performed within 14 days
Predictive value (positive and negative)
Time Frame: OGTTs performed within 14 days
Both home-based OGTTs versus a standard OGTT in controlled setting
OGTTs performed within 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's perception
Time Frame: OGTTs performed within 14 days
Visual analog scale questionnaire
OGTTs performed within 14 days
Cost evaluation of methods
Time Frame: OGTTs performed within 14 days
Estimated cost of each methods
OGTTs performed within 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherches Cliniques de Montreal

Collaborators

Vertex Pharmaceuticals Incorporated
Université de Montréal

Investigators

  • Principal Investigator: Rémi Rabasa-Lhoret, MD, PhD, Montreal Research Clinical Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 13, 2017

Primary Completion (ACTUAL)

April 1, 2020

Study Completion (ACTUAL)

April 1, 2020

Study Registration Dates

First Submitted

July 18, 2017

First Submitted That Met QC Criteria

July 21, 2017

First Posted (ACTUAL)

July 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 25, 2020

Last Update Submitted That Met QC Criteria

June 24, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AtHome

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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