C-Carbs: A CGM-guided Approach to Teaching Carb Awareness
ConditionType 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Pregnancy or plans to become pregnant during the study period.
Current participation in another interventional study that could affect diabetes management or study outcomes.
Trial design
Design model
Parallel
Treatments tested in this trial
C-Carbs Program
BehavioralThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to Study Completion, 4 monthsSecondary outcomes
1
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.
Time frame
Baseline to Study Completion, 4 months2
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.
Time frame
Baseline to Study Completion, 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov