40 Participants NeededMy employer runs this trial

C-Carbs Program for Diabetes

(C-Carbs Trial)

ES
RL
Overseen ByRebecca Lopez, B.A
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

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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

I am 18 years old or older.
I have had diabetes for at least one year.
HbA1c ≥8% at screening/baseline
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Exclusion Criteria

Current participation in another interventional study that could affect diabetes management or study outcomes
I do not have any major health or mental issues that would prevent me from joining the study.
Limited life expectancy that would prevent completion of the study
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the C-CARBS intervention or continue usual care, with four weekly education sessions for the intervention group

4 weeks
4 visits (in-person for intervention group), phone calls for control group

Follow-up

Participants are monitored for changes in insulin dosing behaviors and glycemic outcomes, including HbA1c and Time in Range

4 months

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

Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

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.

4.

lowcarbprogram.com

lowcarbprogram.com/research/

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 ...

The 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 ...