Type 2 Diabetes
Conditions
Keywords
type 2 diabetes, non-insulin, continuous glucose monitoring, AI camera, periodic use
Brief summary
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.
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.
Interventions
DEVICEContinuous Glucose Monitoring
Continuous glucose monitoring is a wearable device that continuously collects glucose data from interstitial fluid.
DEVICESelf-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.
DEVICEAI food camera
The AI food camera automatically detects the contents and nutritional information of foods.
DEVICEFood diary
A food diary is a record in which the user manually writes down the consumed foods and their amounts.
Sponsors
Daewoong Pharmaceutical Co. LTD.
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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. | 6 month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 | 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 | 6 month follow-up | — |
| Change in HbA1c between baseline and the 6-month mark, non-inferiority comparison between treatment group 1 and treatment group 2. | 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 | 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 | 6 month follow-up | — |
| Change in patient satisfaction questionnaires between baseline and the 6-month mark, comparison between groups. | 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. |
| 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 | 6 month follow-up | — |
Countries
South Korea
Outcome results
None listed