NCT07807280

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026Nov 2028

First Submitted

Initial submission to the registry

August 27, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

September 8, 2026

Status Verified

August 1, 2026

Enrollment Period

1.7 years

First QC Date

August 27, 2026

Last Update Submit

September 2, 2026

Conditions

Type 1 Diabetes

Keywords

DiabetesCarbohydrate CountingCGM

Outcome Measures

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.

    Baseline to Study Completion, 4 months

Secondary Outcomes (2)

  • Change in Time in Range (TIR)

    Baseline to Study Completion, 4 months

  • Change in Mealtime Insulin Dosing Behaviors

    Baseline to Study Completion, 4 months

Study Arms (2)

Control

NO INTERVENTION

Participants will continue usual care and receive brief phone calls from research coordinator for breif diabetes education.

Intervention

EXPERIMENTAL

Particpants will meet with a diabetes educator to complete the C-Carbs program.

Behavioral: C-Carbs Program

Interventions

C-Carbs ProgramBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Estelle Everett, MD, MHS

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Shaw, B.S

CONTACT

310-905-1822EEShaw@mednet.ucla.edu

Rebecca Lopez, B.A

CONTACT

RebeccaLopez@mednet.ucla.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 8, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

September 8, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)