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C-Carbs: A CGM-guided Approach to Teaching Carb Awareness

A Novel Approach to Teaching Carb Awareness to Vulnerable Patients With Type 1 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Participants in both groups will complete study assessments throughout the study, including questionnaires and four 3-day meal and insulin logs."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether lessons using a continuous glucose monitor (CGM), a device that tracks blood sugar, help adults improve mealtime insulin doses and blood sugar levels. It is for adults with diabetes who do not regularly or correctly count carbs to plan insulin doses. Participants are assigned by chance to get the lessons or usual care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have had diabetes for at least 1 year.
  • You use a CGM or are willing to start using one.
  • You take insulin shots several times a day.
  • Your HbA1c, a blood test showing average blood sugar over time, is 8% or higher at the start.
  • You do not regularly count carbs for mealtime insulin doses, or your carb counting is not accurate or consistent.
  • You can and will attend study visits and lesson sessions.
  • You can give informed consent, meaning you understand the study and agree to join.

Who can't join

  • You use an insulin pump or a system that delivers insulin automatically.
  • The study doctor thinks a major health, thinking, memory, or mental health problem would keep you from taking part or finishing study tasks.
  • You are not expected to live long enough to finish the study.
  • You are pregnant or plan to become pregnant during the study.
  • You are in another study testing a treatment or program that could affect your diabetes care or this study's results.
  • You cannot or will not use a CGM or give yourself insulin on your own.
  • The study doctor thinks another condition makes joining unsuitable or could interfere with the study's goals.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

CA