Type 1 DiabetesC-CarbsNCT07807280
C-Carbs: A CGM-guided Approach to Teaching Carb Awareness
A study testing C-Carbs Program in people with Type 1 Diabetes, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- C-Carbs Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2026to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rebecca Lopez, B.A contact
United States1 site, 1 recruiting
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Erin Shaw, B.S, 310-905-1822, EEShaw@mednet.ucla.edu
Rebecca Lopez, B.A, RebeccaLopez@mednet.ucla.edu
About this study
Official title: A Novel Approach to Teaching Carb Awareness to Vulnerable Patients With Type 1 Diabetes
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:
- 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.
Read the detailed description
The C-CARBS study is a randomized controlled study evaluating a patient-facing education program designed to help adults with diabetes use continuous glucose monitoring (CGM) data to guide mealtime insulin dosing. The study focuses on adults with diabetes who use CGM and multiple daily insulin injections (MDI) and who do not routinely use carbohydrate counting or have difficulty with carbohydrate counting.
Participants will be randomly assigned to either the C-CARBS intervention or usual care. Participants assigned to the intervention will receive four weekly, one-hour education sessions with a Certified Diabetes Care and Education Specialist. The sessions will focus on using CGM information, including current glucose levels and glucose trends, to support mealtime insulin dosing without relying solely on traditional carbohydrate counting.
Participants in both groups will complete study assessments throughout the study, including questionnaires and four 3-day meal and insulin logs. Meal and insulin information may be recorded manually or through the participant's Dexcom app. CGM data and laboratory measures, including hemoglobin A1c (HbA1c), will be collected to evaluate changes in glycemic outcomes. The study will also assess participants' insulin dosing behaviors, use of diabetes technology, and experience with the intervention.
The primary goal of the study is to determine whether the C-CARBS education program can improve mealtime insulin dosing behaviors and glycemic outcomes among adults with diabetes who do not routinely use carbohydrate counting.
- Conditions
- Type 1 Diabetes
- Being tested
- C-Carbs Program
- Keywords
- Diabetes, Carbohydrate Counting, CGM
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Carbs ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will continue usual care and receive brief phone calls from research coordinator for breif diabetes education. |
| Intervention | Experimental | Particpants will meet with a diabetes educator to complete the C-Carbs program. Receives: Behavioral: C-Carbs Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1C
Change in HbA1c from baseline to follow-up will be compared between participants randomized to the C-CARBS intervention and usual care.
Measured: Baseline to Study Completion, 4 months
Secondary outcomes (2)
Change in Time in Range (TIR)
Change in the percentage of time participants' glucose levels are within the target range (70-180 mg/dL), as measured by CGM.
Measured: Baseline to Study Completion, 4 months
Change in Mealtime Insulin Dosing Behaviors
Change in participants' reported approaches to determining mealtime insulin doses, including use of CGM glucose values and trends and carbohydrate counting.
Measured: Baseline to Study Completion, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start16 Nov 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Estelle M. Everett, MD, MHS, University of California, Los Angeles
- Investigators
- Estelle Everett, MD, MHS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807280
- Sponsor's protocol ID
- 24-5893
- Acronym
- C-Carbs
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Teaching Carb Awareness to Vulnerable Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07807280
- Acronym / sponsor ID
- C-Carbs / 24-5893
- Conditions
- Type 1 Diabetes
- Keywords
- Diabetes, Carbohydrate Counting, CGM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 8 Sep 2026 (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 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:
- 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.
Detailed description
The C-CARBS study is a randomized controlled study evaluating a patient-facing education program designed to help adults with diabetes use continuous glucose monitoring (CGM) data to guide mealtime insulin dosing. The study focuses on adults with diabetes who use CGM and multiple daily insulin injections (MDI) and who do not routinely use carbohydrate counting or have difficulty with carbohydrate counting.
Participants will be randomly assigned to either the C-CARBS intervention or usual care. Participants assigned to the intervention will receive four weekly, one-hour education sessions with a Certified Diabetes Care and Education Specialist. The sessions will focus on using CGM information, including current glucose levels and glucose trends, to support mealtime insulin dosing without relying solely on traditional carbohydrate counting.
Participants in both groups will complete study assessments throughout the study, including questionnaires and four 3-day meal and insulin logs. Meal and insulin information may be recorded manually or through the participant's Dexcom app. CGM data and laboratory measures, including hemoglobin A1c (HbA1c), will be collected to evaluate changes in glycemic outcomes. The study will also assess participants' insulin dosing behaviors, use of diabetes technology, and experience with the intervention.
The primary goal of the study is to determine whether the C-CARBS education program can improve mealtime insulin dosing behaviors and glycemic outcomes among adults with diabetes who do not routinely use carbohydrate counting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will continue usual care and receive brief phone calls from research coordinator for breif diabetes education. |
| Intervention | Experimental | Behavioral: C-Carbs ProgramParticpants will meet with a diabetes educator to complete the C-Carbs program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| C-Carbs ProgramThe 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. | Behavioural | Intervention |
Primary outcome
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.
2 secondary outcomes
Change in Time in Range (TIR)
Time frame: Baseline to Study Completion, 4 months
Change in Mealtime Insulin Dosing Behaviors
Time frame: Baseline to Study Completion, 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- 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.
Rebecca Lopez, B.A contact
Estelle Everett, MD, MHS principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Carbs Program in people with Type 1 Diabetes, run by University of California, Los Angeles 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 8 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: looking for participants now, as of the sponsor's last update on 4 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Shaw, B.S (310-905-1822, EEShaw@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1C (time frame: Baseline to Study Completion, 4 months). 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 4 Nov 2026.