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Completed

NCT Number: NCT06594055

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuksamsung Hospital

Seoul, 00000, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Continuous glucose monitoring

Device

Continuous glucose monitoring is a wearable device that continuously collects glucose data from interstitial fluid.

Self-monitoring blood glucose

Device

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.

AI food camera

Device

The AI food camera automatically detects the contents and nutritional information of foods.

Food diary

Device

A food diary is a record in which the user manually writes down the consumed foods and their amounts.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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. 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

  4. 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

  5. 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. 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

  7. 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

  8. 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.

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Collaborators

  • Daewoong Pharmaceutical Co. LTD.

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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