Simplification of CF-related Diabetes Screening at Home

NCT03227094 | Completed

• 1 other identifier: AtHome
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

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that only 47% of non-diabetic patients attended to planned screening despite large availability and advertisement (unpublished data).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

Conditions

Cystic Fibrosis; Cystic Fibrosis-related Diabetes

Keywords

Diabetes; Screening test; Continuous glucose monitoring; Oral glucose tolerance test

Outcome Measures

Primary Outcomes (2)

• Internal validity

  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)

  Both home-based OGTTs versus a standard OGTT in controlled setting

  OGTTs performed within 14 days

Secondary Outcomes (2)

• Patient's perception

  OGTTs performed within 14 days

• Cost evaluation of methods

  OGTTs performed within 14 days

Study Arms (3)

Standard OGTT

OTHER

OGTT standard test at hospital (75g glucose beverage; 2-h test with plasma glucose collection)

Diagnostic Test: Standard OGTT

Home-based OGTT (Beverage)

EXPERIMENTAL

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)

Home-based OGTT (Candy)

EXPERIMENTAL

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)

Interventions

Standard OGTT DIAGNOSTIC_TEST

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

Standard OGTT

Home-based OGTT (Beverage) DIAGNOSTIC_TEST

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

Home-based OGTT (Beverage)

Home-based OGTT (Candy) DIAGNOSTIC_TEST

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

Home-based OGTT (Candy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known CFRD
• Recent exacerbation
• Use medications known to interfere with glucose metabolism such as oral steroids.

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead
• Université de Montréal: collaborator
• Vertex Pharmaceuticals Incorporated: collaborator

Study Sites (2)

Montreal Clinical Research Institute (IRCM)

Montreal, Quebec, H2W 1R7, Canada

Location

CHUM

Montreal, Quebec, H2W1R7, Canada

Location

MeSH Terms

Conditions

Cystic Fibrosis; Diabetes Mellitus

Interventions

Beverages; Candy

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Food

Study Officials

• Rémi Rabasa-Lhoret, MD, PhD

  Montreal Research Clinical Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 24, 2017
• Study Start: November 13, 2017
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)