Cystic FibrosisAtHomeNCT03227094
Simplification of CF-related Diabetes Screening at Home
A study testing Standard OGTT, Home-based OGTT (Beverage) and Home-based OGTT (Candy) in people with Cystic Fibrosis and Cystic Fibrosis-related Diabetes, run by Institut de Recherches Cliniques de Montreal at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes
- What is being tested?
- Standard OGTT, Home-based OGTT (Beverage) and Home-based OGTT (Candy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesCanada
- Study dates
- 13 Nov 2017to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult CF-patient without known diabetes
- In stable condition at least 1-month apart from the last exacerbation.
Who cannot join
- Known CFRD
- Recent exacerbation
- Use medications known to interfere with glucose metabolism such as oral steroids.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Montreal Clinical Research Institute (IRCM)
Montreal, Quebec, H2W 1R7
CHUM
Montreal, Quebec, H2W1R7
About this study
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
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.
Read the 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.
- Conditions
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes
- Being tested
- Standard OGTT, Home-based OGTT (Beverage), Home-based OGTT (Candy)
- Keywords
- Diabetes, Screening test, Continuous glucose monitoring, Oral glucose tolerance test
- Medical subject headings
- Cystic Fibrosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard OGTTDiagnostic 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
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 (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
| Study group | Role | What they receive |
|---|---|---|
| Standard OGTT | Other | OGTT standard test at hospital (75g glucose beverage; 2-h test with plasma glucose collection) Receives: 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) Receives: 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) Receives: Diagnostic Test: Home-based OGTT (Candy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal validity
Specificity and sensitivity of both home-based OGTTs versus a standard OGTT in controlled setting
Measured: OGTTs performed within 14 days
Predictive value (positive and negative)
Both home-based OGTTs versus a standard OGTT in controlled setting
Measured: OGTTs performed within 14 days
Secondary outcomes (2)
Patient's perception
Visual analog scale questionnaire
Measured: OGTTs performed within 14 days
Cost evaluation of methods
Estimated cost of each methods
Measured: OGTTs performed within 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start13 Nov 2017
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal, Vertex Pharmaceuticals Incorporated
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Rémi Rabasa-Lhoret, MD, PhD, Principal investigator, Montreal Research Clinical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227094
- Sponsor's protocol ID
- AtHome
- Acronym
- AtHome
- Status last verified
- Jun 2020
- First submitted
- 18 Jul 2017
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03227094
- Acronym / sponsor ID
- AtHome / AtHome
- Conditions
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes
- Keywords
- Diabetes, Screening test, Continuous glucose monitoring, Oral glucose tolerance test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Collaborators
- Université de Montréal, Vertex Pharmaceuticals Incorporated
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard OGTT | Other | Diagnostic Test: Standard OGTTOGTT standard test at hospital (75g glucose beverage; 2-h test with plasma glucose collection) |
| Home-based OGTT (Beverage) | Experimental | Diagnostic Test: Home-based OGTT (Beverage)Home-based OGTT with CGM device, without glucose collection (75g glucose beverage; 2-h test: glycemia measured by CGM) |
| Home-based OGTT (Candy) | Experimental | Diagnostic Test: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult CF-patient without known diabetes
- In stable condition at least 1-month apart from the last exacerbation.
Key exclusion criteria (3 listed)
- Known CFRD
- Recent exacerbation
- Use medications known to interfere with glucose metabolism such as oral steroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard OGTTStandard-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 | Diagnostic test | Standard OGTT |
| 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 | Diagnostic test | Home-based OGTT (Beverage) |
| 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 | Diagnostic test | Home-based OGTT (Candy) |
Primary outcome
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
2 secondary outcomes
Patient's perception
Time frame: OGTTs performed within 14 days
Cost evaluation of methods
Time frame: OGTTs performed within 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémi Rabasa-Lhoret, MD, PhD principal investigator
Montreal Research Clinical Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard OGTT, Home-based OGTT (Beverage) and Home-based OGTT (Candy) in people with Cystic Fibrosis and Cystic Fibrosis-related Diabetes, run by Institut de Recherches Cliniques de Montreal at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal validity (time frame: OGTTs performed within 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.