CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-55
SponsorIndiana University
About this trial
The primary objective of this pilot study is to develop a CGM-based model to predict the progression from prediabetes to diabetes in individuals with cystic fibrosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
CF individuals aged 12-55 years.
CF without diabetes or with prediabetes (as defined by OGTT and HbA1c).
Willing to use a continuous glucose monitoring system with compatible smart phone for glucose data collection.
Disqualifiers
Pregnancy.
History of transplant.
Use of immunosuppressant drugs.
Use of oral steroids or any medication known to interfere with glucose.
Trial design
Design model
Single group
Treatments tested in this trial
CGM Dynamic Index (CDI)
DeviceParticipants will undergo one-time oral glucose tolerance test (OGTT) and a one-time use of a CGM device, which will be worn for up to 10 days.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: CF without diabetesOther 1 intervention
Group B: CF with PrediabetesOther 1 intervention
Trial outcomes
Primary outcomes
1
CGM Dynamic Index (CDI) for predicting prediabetes in people with cystic fibrosis
Estimating the "optimal" cut-offs of the CDI marker, to distinguish between CF groups
Time frame
10 daysSponsors and contacts
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Source ClinicalTrials.gov