CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis

Indiana University

Status: Enrolling

Conditions: Prediabetes; Cystic Fibrosis-related Diabetes; Cystic Fibrosis (CF)

Treatments: Device: CGM Dynamic Index (CDI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06642610

24262

DartCF funded by NIH/ NIDDK (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 12 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

CF without diabetes

Other group

Description:

a person with cystic fibrosis and no diabetes

Treatment:

Device: CGM Dynamic Index (CDI)

CF with Prediabetes

Other group

Description:

a person with cystic fibrosis and prediabetes

Treatment:

Device: CGM Dynamic Index (CDI)