PrediabetesNCT06642610
CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis
A study testing CGM Dynamic Index (CDI) in people with Prediabetes and Cystic Fibrosis (CF), run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Prediabetes, Cystic Fibrosis (CF), Cystic Fibrosis-related Diabetes
- What is being tested?
- CGM Dynamic Index (CDI)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2025to 30 Jun 2026
- 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 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- A person with CFRD and already using CGM, we will just collect their personal CGM data, and they are not required to have OGTT or HbA1c visit.
Who cannot join
- Pregnancy.
- History of transplant.
- Use of immunosuppressant drugs.
- Use of oral steroids or any medication known to interfere with glucose.
- Allergy to adhesives.
- Individuals with severe concurrent medical conditions that could confound glucose monitoring data (e.g., terminal illness, major organ failure).
- Conditions that may make unsafe for participants to do study or impair or confound the study at the discretion of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health, University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: CGM Dynamic Index (CDI) for Predicting Prediabetes in People With Cystic Fibrosis
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.
- Being tested
- CGM Dynamic Index (CDI)
- Medical subject headings
- Prediabetic State, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM Dynamic Index (CDI)Device
Also called CGM Dynamic Index (CDI) mathematical model
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| CF without diabetes | Other | a person with cystic fibrosis and no diabetes Receives: Device: CGM Dynamic Index (CDI) |
| CF with Prediabetes | Other | a person with cystic fibrosis and prediabetes Receives: Device: CGM Dynamic Index (CDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Jun 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viral N. Shah, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642610
- Sponsor's protocol ID
- 24262
- Other IDs
- DartCF funded by NIH/ NIDDK
- Status last verified
- Jul 2025
- First submitted
- 10 Oct 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CGM Dynamic Index (CDI) for Predicting Prediabetes in People With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06642610
- Acronym / sponsor ID
- 24262
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 15 Oct 2024 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CF without diabetes | Other | Device: CGM Dynamic Index (CDI)a person with cystic fibrosis and no diabetes |
| CF with Prediabetes | Other | Device: CGM Dynamic Index (CDI)a person with cystic fibrosis and prediabetes |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
- A person with CFRD and already using CGM, we will just collect their personal CGM data, and they are not required to have OGTT or HbA1c visit.
Key exclusion criteria (7 listed)
- Pregnancy.
- History of transplant.
- Use of immunosuppressant drugs.
- Use of oral steroids or any medication known to interfere with glucose.
- Allergy to adhesives.
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 |
|---|---|---|
| CGM Dynamic Index (CDI)Also: CGM Dynamic Index (CDI) mathematical modelParticipants 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. | Device | CF with Prediabetes, CF without diabetes |
Primary outcome
CGM Dynamic Index (CDI) for predicting prediabetes in people with cystic fibrosis
Time frame: 10 days
Estimating the "optimal" cut-offs of the CDI marker, to distinguish between CF groups
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 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM Dynamic Index (CDI) in people with Prediabetes and Cystic Fibrosis (CF), run by Indiana University at 1 site in United States.
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 4 inclusion and 7 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
CGM Dynamic Index (CDI) for predicting prediabetes in people with cystic fibrosis (time frame: 10 days). 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 17 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.