C-Carbs Program for Diabetes
(C-Carbs Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether an educational program, the C-Carbs Program, can help people with diabetes improve insulin use at mealtimes by using a continuous glucose monitor (CGM). Participants will be divided into two groups: one will follow the new program, while the other will continue with their usual care. This study targets adults who have had diabetes for at least a year, use daily insulin shots, and do not typically count carbohydrates when dosing insulin. Participants must be willing to use a CGM and attend study sessions. The goal is to determine if this approach can enhance insulin use and blood sugar control. As an unphased trial, this study provides a unique opportunity to explore innovative diabetes management strategies and contribute to advancing care for others.
What prior data suggests that the C-Carbs Program is safe for adults with diabetes?
Research has shown that diabetes self-management education programs, such as the C-Carbs Program, are generally safe. Studies indicate that these educational methods help people with diabetes manage their blood sugar levels more effectively without serious side effects. For instance, one study found that participants who received detailed education improved their blood sugar control over time. These programs teach skills that can help prevent or delay diabetes-related issues, such as heart disease or kidney problems, without causing harm. Therefore, the C-Carbs Program, which focuses on teaching about insulin dosing, is likely well-tolerated based on similar programs.12345
Why are researchers excited about this trial?
Researchers are excited about the C-Carbs Program for diabetes because it shifts the focus from traditional medication management to personalized lifestyle education. Unlike standard treatments like insulin therapy or oral hypoglycemics, this program involves direct interaction with a diabetes educator to tailor carbohydrate management specifically to individual needs. This hands-on, educational approach aims to empower individuals with diabetes to better understand and control their condition, potentially leading to more sustainable and effective management of their blood sugar levels.
What evidence suggests that the C-Carbs Program is effective for improving insulin dosing in adults with diabetes?
Research has shown that technology-assisted insulin dosing can improve blood sugar control in people with diabetes. For example, one study found that 55% of participants using a tech-based program reduced their HbA1c levels to below 6.5%. HbA1c measures average blood sugar levels over several months. Another study found that low-carb diets, which can aid in insulin management, led to slight improvements in blood sugar. In this trial, participants in the intervention arm will complete the C-Carbs program, which uses continuous glucose monitoring (CGM) to guide insulin dosing, potentially enhancing diabetes management.678910
Who Is on the Research Team?
Estelle Everett, MD, MHS
Principal Investigator
University of California, Los Angeles
Are You a Good Fit for This Trial?
This trial is for adults with type 1 diabetes or diabetic foot ulcers who do not regularly count carbohydrates when dosing their mealtime insulin. Participants should be able to attend study visits and complete logs and questionnaires.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the C-CARBS intervention or continue usual care, with four weekly education sessions for the intervention group
Follow-up
Participants are monitored for changes in insulin dosing behaviors and glycemic outcomes, including HbA1c and Time in Range
What Are the Treatments Tested in This Trial?
Interventions
- C-Carbs Program
Trial Overview
The study compares a new education program (C-Carbs) that uses continuous glucose monitoring (CGM) to guide insulin dosing, versus usual care. Participants are randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Particpants will meet with a diabetes educator to complete the C-Carbs program.
Participants will continue usual care and receive brief phone calls from research coordinator for breif diabetes education.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
Citations
Effectiveness of low-carbohydrate diets on type 2 diabetes
LCDs show modest 3-month glycemic improvements: 0.29% HbA1c reduction. •. Cultural context significantly influences low-carb diet metabolic responses. •. Short- ...
Effectiveness of Technology-Enabled, Low Carbohydrate ...
At 32 weeks the RCT by Saslow et al. reported that 55% of participants in the intervention group had reduced their HbA1c at levels below 6.5% [ ...
Effects of a Low-Carbohydrate Dietary Intervention on ...
Importance Low-carbohydrate diets decrease hemoglobin A1c (HbA1c) among patients with type 2 diabetes at least as much as low-fat diets.
Research
Peer-reviewed one-year health outcomes. We're currently conducting a three year study following 1,000 people with type 2 diabetes who enrolled on the ...
Low-Carb Diet May Help Achieve Type 2 Diabetes ...
A review found that a low-carbohydrate diet may lead patients with type 2 diabetes to experience disease remission, potentially providing new ...
The dietary education trial in carbohydrate counting (DIET ...
One study also found that underestimation of carbohydrate-rich meals was associated with higher daily plasma glucose variability in adults with T1D.20 Thus, ...
A CGM-guided Approach to Teaching Carb Awareness
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 ...
About Diabetes Self-Management Education and Support
DSMES helps you manage diabetes so you can prevent or delay serious diabetes complications like heart disease, kidney disease, amputations, and ...
Impact of a multidisciplinary intensive education program on ...
The results indicate improved glycemic control where patients' HbA1c and blood sugar levels were significantly reduced 3, 6, and 12 months after MIEP compared ...
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examine.com
examine.com/research-feed/study/1ag4L9/?srsltid=AYCX9vKtb7kzU1flqVAatjHmAzRDfujONszeVhIOy0LguHBYjsSVD-GgThe efficacy of a basic carbohydrate counting education ...
In this randomized controlled trial in participants with type 2 diabetes, a basic carbohydrate-counting education program was no better than ...
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