Periodic Use of Continuous Glucose Monitoring With Personalized Diet Interventions Using AI Camera Among Non-insulin Treated Type 2 Diabetes

March 4, 2025 updated by: Sun Joon, Moon, Kangbuk Samsung Hospital
The aim of this study is to evaluate the periodic use of continuous glucose monitoring (CGM) with an AI camera and following diet education among non-insulin-treated type 2 diabetes patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The control group used self-monitoring blood glucose (SMBG) for two weeks with a manual food diary followed by diet education and repeated SMBG with a food diary three months later. Treatment 1 group used CGM (Freestyle Libre) for two weeks with an AI food camera followed by diet education, and repeated CGM for two weeks with an AI food camera three months later. Treatment 2 group used CGM for two weeks with an AI food camera followed by diet education without repeat three months later. Every group followed at 6 months for the final outcome. HbA1c at 6 months is the primary outcome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Type 2 diabetes patients
  2. HbA1c 6.5% - 10%
  3. No medication changes in the past 3 months, and receiving treatment with lifestyle modification or oral antidiabetic drugs or GLP-1 receptor agonists
  4. Ages 18 - 80 years old

Exclusion Criteria:

  1. Insulin users
  2. Those who have used steroids within the past 3 months or are expected to use them during the study period (excluding ointments)
  3. Type 1 diabetes patients
  4. Patients who have undergone pancreatic resection
  5. Patients undergoing hemodialysis or peritoneal dialysis
  6. Those requiring continuous MRI and CT scans
  7. Those deemed by the researcher to have difficulty handling continuous glucose monitors and AI cameras
  8. Those deemed unsuitable for participation in this clinical trial by the investigator, other than those mentioned above
  9. Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control
The control group used self-monitoring blood glucose (SMBG) for two weeks with a manual food diary, followed by diet education. They then repeated SMBG with a food diary three months later, with a final follow-up at the 6-month mark.
Device: Self-monitoring blood glucose
The control group used self-monitoring blood glucose (SMBG) for two weeks with a manual food diary, followed by diet education. They then repeated SMBG with a food diary three months later, with a final follow-up at the 6-month mark.
Device: Food diary
A food diary is a record in which the user manually writes down the consumed foods and their amounts.
Experimental: Treatment 1
Treatment 1 group used CGM (Freestyle Libre) for two weeks with an AI food camera, followed by diet education. They then repeated CGM for two weeks with an AI food camera three months later, with a final follow-up at the 6-month mark.
Device: Continuous Glucose Monitoring
Continuous glucose monitoring is a wearable device that continuously collects glucose data from interstitial fluid.
Device: AI food camera
The AI food camera automatically detects the contents and nutritional information of foods.
Experimental: Treatment 2
Treatment 2 group used CGM for two weeks with an AI food camera, followed by diet education, without a repeat three months later. They had a final follow-up at the 6-month mark.
Device: Continuous Glucose Monitoring
Continuous glucose monitoring is a wearable device that continuously collects glucose data from interstitial fluid.
Device: AI food camera
The AI food camera automatically detects the contents and nutritional information of foods.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in HbA1c between baseline and the 6-month mark in treatment 1 group compared to control group, and treatment 2 group compared to control group.
Time Frame: 6 month follow-up
6 month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c between baseline and the 6-month mark, non-inferiority comparison between treatment group 1 and treatment group 2.
Time Frame: 6 month follow-up
6 month follow-up
Change in HbA1c between baseline and the 3-month mark in treatment 1 group compared to control group, and treatment 2 group compared to control group.
Time Frame: 3 month follow-up
3 month follow-up
Change in blood pressure between baseline and the 6-month mark in treatment 1 group compared to control group, and treatment 2 group compared to control group
Time Frame: 6 month follow-up
6 month follow-up
Change in lipid parameters between baseline and the 6-month mark in treatment 1 group compared to control group, and treatment 2 group compared to control group
Time Frame: 6 month follow-up
6 month follow-up
Change in body weight between baseline and the 6-month mark in treatment 1 group compared to control group, and treatment 2 group compared to control group
Time Frame: 6 month follow-up
6 month follow-up
Change in waist circumference between baseline and the 6-month mark in treatment 1 group compared to control group, and treatment 2 group compared to control group
Time Frame: 6 month follow-up
6 month follow-up
Glycemic metrics of blinded CGM once at 6-month mark in treatment 1 group compared to control group, and treatment 2 group compared to control group
Time Frame: 6 month follow-up
6 month follow-up
Change in patient satisfaction questionnaires between baseline and the 6-month mark, comparison between groups.
Time Frame: 6 month follow-up
Diabetes management self-efficacy scale (DMSES), appraisal of diabetes scale (ADS), and the summary of diabetes self-care activities measure (SDSCA) were used. DMSES has a 0-10 score scale for each item, with higher scores indicating better outcomes. ADS has a 1-5 score scale where lower scores are better in the psychological impact of diabetes subscale, and higher scores are better in the sense of self-control subscale. SDSCA has a 0-7 score scale for each item, with higher scores indicating better outcomes in the Diet, Exercise, Glucose monitoring, and Foot care subscales, while lower scores are better in the smoking subscale.
6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kangbuk Samsung Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KBSMC 2022-04-043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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