Type 1 Diabetes
Conditions
Keywords
Diabetes, Carbohydrate Counting, CGM
Brief 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\. 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.
Interventions
BEHAVIORALC-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.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1C | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time in Range (TIR) | Baseline to Study Completion, 4 months | Change in the percentage of time participants' glucose levels are within the target range (70-180 mg/dL), as measured by CGM. |
| Change in Mealtime Insulin Dosing Behaviors | Baseline to Study Completion, 4 months | Change in participants' reported approaches to determining mealtime insulin doses, including use of CGM glucose values and trends and carbohydrate counting. |
Countries
United States
Contacts
CONTACTErin Shaw, B.S
CONTACTRebecca Lopez, B.A
PRINCIPAL_INVESTIGATOREstelle Everett, MD, MHS
University of California, Los Angeles
Outcome results
None listed