NCT07807280 · University of California, Los Angeles
C-Carbs: A CGM-guided Approach to Teaching Carb Awareness
(C-Carbs)
What this study is about
The goal of this randomly assigned study is to learn whether a CGM-guided insulin dosing education program can help adults with diabetes improve how they dose mealtime insulin. The main question it aims to answer is: 1\.
View original scientific description
The goal of this randomized study is to learn whether a CGM-guided insulin dosing education program can help adults with diabetes improve how they dose mealtime insulin. The main question it aims to answer is: 1\. Does CGM-guided insulin dosing education improve insulin dosing behaviors and glycemic outcomes in adults with diabetes who do not routinely use carbohydrate counting? Participants will be randomly assigned to either the C-CARBS intervention or usual care. Participants will complete study visits, questionnaires, and meal and insulin logs, and CGM data will be collected to evaluate changes in insulin dosing behaviors and glycemic outcomes.
Interventions
BEHAVIORAL
C-Carbs Program
The C-CARBS intervention is a patient-facing diabetes education program consisting of four weekly, one-hour sessions with a diabetes educator. The program teaches participants how to use continuous glucose monitoring (CGM) information, including current glucose levels and glucose trends, to guide mealtime insulin dosing. The intervention is designed to provide practical strategies for insulin dosing without relying solely on traditional carbohydrate counting. Participants will also practice applying CGM information to real-world meals and insulin dosing decisions.
Primary outcome measures
Change in HbA1C
Time frame: Baseline to Study Completion, 4 months
Change in HbA1c from baseline to follow-up will be compared between participants randomized to the C-CARBS intervention and usual care.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adults 18 years of age or older.
- Diagnosis of diabetes for at least 1 year.
- Currently using or willing to start using a continuous glucose monitor (CGM).
- Currently using multiple daily insulin injections (MDI).
- HbA1c ≥8% at screening/baseline.
- Does not routinely use carbohydrate counting or demonstrates poor/inconsistent carbohydrate counting for mealtime insulin dosing.
- Able and willing to participate in the study visits and intervention sessions.
- Able to provide informed consent.
Exclusion criteria
- Use of an insulin pump or automated insulin delivery system.
- Significant medical, cognitive, or psychiatric condition that, in the investigator's judgment, would interfere with participation or completion of study procedures. Limited life expectancy that would prevent completion of the study.
- Pregnancy or plans to become pregnant during the study period.
- Current participation in another interventional study that could affect diabetes management or study outcomes.
- Inability/unwillingess to independently use a CGM device or administer insulin.
- Any other condition that, in the investigator's judgment, would make participation inappropriate or interfere with the study's objectives.
Where
- Los Angeles, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 8, 2026 · Source of record for eligibility and locations