An interventional study of Continuous Glucose Monitoring With Application-Based Biofeedback and Common Standardized Education and Behavioral Goal Setting in Prediabetes, Dietary Self-Management and Diabetes Mellitus, Type 2, sponsored by Ji-Yeob Choi. Not yet recruiting at 4 sites in South Korea. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Ji-Yeob Choi · Not applicable, Interventional, and Prevention
This study will test whether adding a continuous glucose monitoring (CGM) device, which shows personal glucose patterns, improves dietary self-management over the first 6 weeks. Both groups receive the same digital health program, standardized education, and support for setting behavioral goals. It will include 860 residents of Namwon, Republic of Korea, aged 40 years or older who have elevated fasting glucose or documented type 2 diabetes diagnosis or treatment.
After screening, participants will be assigned by chance to one of two groups of 430. Assignment is preferably on the first screening visit but may occur later. The actual assignment date is Day 0. The device group will use one CGM sensor for approximately 10 days after assignment. The wait-list control group will receive the same education and behavioral goal-setting support during the first 6 weeks, without a CGM device. Researchers will compare dietary self-management scores at week 6, before the control group receives a sensor.
After the week 6 assessment and data lock, the control group will also be offered a sensor so that all eligible randomized participants have an opportunity to use the device. This later offer is not the main intervention comparison. Week 12 assessments provide exploratory follow-up after both groups have been offered a device. Researchers will also assess application use, body weight, waist circumference, blood pressure, and safety. The research team will not change medicines based on sensor readings, and usual medical care will continue.
This community-based, individually randomized, open-label, wait-list controlled study evaluates the incremental effect of adding a continuous glucose monitoring (CGM) device as a personal glucose biofeedback tool to a common digital health and education program during the first 6 weeks. The randomized comparison is device provision versus no device provision during this period; standardized education and behavioral goal setting are common to both groups. Approximately 3,000 residents are expected to undergo screening to identify 860 eligible participants who provide additional written consent for randomization. Screening participants who do not enter the randomized study are not part of its control group. Their separately consented optional week 12 follow-up will be analyzed descriptively and separately from the randomized comparison. For these nonrandomized participants, the optional follow-up window is Days 77-91 after the first screening visit.
The actual randomization date is Day 0. Randomization is preferably completed at the first screening visit after eligibility verification, required consent, and baseline assessments, but may occur later without a separate maximum screening-to-randomization interval. Before allocation, willingness to participate, treatment, safety status, and sensor-use changes are rechecked. The week 6 assessment window is Days 35-49 and the week 12 window is Days 77-91 after randomization. Sensor placement delays do not reset Day 0. Screening, consent, baseline assessment, randomization, and sensor placement dates are recorded separately. Scheduling must permit completion within the approved study period and the planned field-assessment end in September 2027.
If screening and randomization occur on different dates, the four dietary self-management items are collected again before allocation using the same wording, response options, and recall periods. The mean of the first three items collected before allocation on the randomization date is the primary baseline score. Same-day assessments are not duplicated. Other baseline questionnaires, AI Diet, and physical measurements use the pre-allocation values from the first screening visit, retaining the measurement dates and screening-to-randomization interval. Post-allocation values are not substituted for baseline. The interval is described by group and included in an additional adjusted sensitivity analysis.
Allocation will be 1:1 using a web-based system operated outside the field research team, with computer-generated variable blocks and three strata: documented type 2 diabetes diagnosis or treatment; no documented diagnosis or treatment with fasting glucose at least 126 mg/dL; and no documented diagnosis or treatment with fasting glucose from 100 through 125 mg/dL. The primary analyst will finalize the analysis plan and code using group labels A and B before the group code is revealed. Participants and field researchers will know the assigned timing.
Beginning at the first screening visit, both groups receive the PASTA application, the commercially available AI Diet dietary assessment and feedback provided through Kakao Healthcare's PASTA application, CancerFree prevention information, digital literacy support, and basic health counseling. Both groups also receive the same standardized education on glucose patterns, relationships of meals, activity and sleep with glucose responses, and safe behavioral goal setting during the first 6 weeks, independently of sensor provision. Education and goal setting are not deferred in the control group. The added intervention is access to the CGM device and linked personal glucose feedback. Sensor placement, connection, and device safety instructions are provided when each group actually starts using its sensor.
The primary comparison is the week 6 dietary self-management score, adjusted for its baseline value, diabetes stratum, and initial enrollment location. The study-specific score is based on the mean of the first three dietary self-management items adapted with revised wording and response guidance from the Korean version of the Summary of Diabetes Self-Care Activities. It is not presented as an independently validated instrument. The fourth item, concerning carbohydrate distribution, is reserved for a sensitivity analysis.
After the week 6 outcome assessment and data lock, the wait-list control group is offered the same sensor so that all eligible randomized participants have an opportunity to receive the device. The first 6 weeks constitute the primary controlled intervention period; each sensor is worn for approximately 10 days, not continuously for 6 weeks. Week 12 assessments are exploratory follow-up after both groups have been offered the sensor. The study is not primarily designed to establish superiority of early versus delayed provision. No on-site blood sampling is planned. Optional psychosocial assessments and planned administrative data linkage, conditional on later separate consent and approvals, are exploratory and do not replace the primary randomized comparison.
AI Diet uses the existing 10 dietary categories and their commercially provided risk-stage table without modification. For the prespecified exploratory analysis, the four category-assigned stages for obesity, diabetes, hypertension, and hypertriglyceridemia are summed. Each stage ranges from 1 (lowest) to 4 (highest); the sums across the 10 existing categories range from 4 to 13. A higher sum indicates a higher combined category-assigned risk stage. This sum is not an individual probability of disease. Category transitions are also examined.
With separate consent, PASTA records actually generated during the 24-month study period may be received for exploratory analyses beyond the 12-week field follow-up. The current National Health Insurance Service linkage-plan and follow-up-contact consent does not authorize actual linkage or collection of resident registration numbers. Actual linkage requires a confirmed lawful processing route, responsible entities, approvals, and later separate explanation and consent. Pseudonymized analysis is planned in the approved National Health Insurance Service environment, with only approved analytical outputs released; individual insurance records are not downloaded or stored by the research team. One linkage is planned after all week 12 visits, within the study period ending in September 2028. Up to five years of records before the first screening visit are used to assess prior history. Incident outcomes are observed from the actual randomization date to the actual linkage date for randomized participants, and from the first screening visit for the separately consented nonrandomized follow-up cohort, subject to record availability. The overall study end is not treated as each participant's observed follow-up end.
Protocol version 8 received ethics approval. The version 9 amendment will undergo ethics review before implementation of the amended study plan.
1,021 studies on the registry are indexed under Prediabetic State; 242 are open to participants now.
This study's planned enrollment of 860 is above the median of 66 across 861 interventional studies indexed under Prediabetic State.
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Exclusion Criteria:
Welfare-center participants who have not used a sensor may enter the main study within the 860-participant target only after approval of the amendment, new informed consent, and confirmation of all eligibility criteria. Previously collected welfare-center data are handled only within the scope permitted by ethics review; public health center pilot data are excluded from the main study analysis.
Participants receive one Dexcom G7 continuous glucose monitoring (CGM) sensor on the actual randomization date (Day 0) or within 10 business days and wear it for approximately 10 days. The device provides personal glucose biofeedback through PASTA during the first 6-week comparison period. Both groups receive the same digital health program, standardized education, and behavioral goal-setting support; these are common background care. Sensor placement, connection, and safety instructions accompany actual device use. The primary assessment is at week 6 (Days 35-49), before the control group is offered a device. Week 12 (Days 77-91) is exploratory follow-up. The dietary baseline is collected before allocation on Day 0; other baseline measures are from the first screening visit. Same-day placement is optional.
Device: Continuous Glucose Monitoring With Application-Based Biofeedback · Behavioral: Common Standardized Education and Behavioral Goal Setting · Behavioral: Common Digital Health Program and Basic Health Counseling
During the first 6 weeks, participants receive the same digital health program, standardized education, and behavioral goal-setting support as the device group, without a CGM device. Education and goal setting are not delayed. The primary assessment is at week 6 (Days 35-49). After that assessment and data lock, participants are offered one Dexcom G7 sensor on that day or within 7 business days, for approximately 10 days, so that all eligible participants have an opportunity to use it. Placement, connection, and device safety instructions accompany this later offer. Same-day placement is optional. Week 12 (Days 77-91) is exploratory follow-up, not a second device-versus-no-device comparison. Day 0 is actual randomization; the dietary baseline is collected before allocation that day and other baseline measures are from the first screening visit.
Device: Continuous Glucose Monitoring With Application-Based Biofeedback · Behavioral: Common Standardized Education and Behavioral Goal Setting · Behavioral: Common Digital Health Program and Basic Health Counseling
One Dexcom G7 sensor is worn for approximately 10 days, with personal glucose patterns displayed through PASTA as biofeedback for lifestyle self-management. The device group starts on the actual randomization date (Day 0) or within 10 business days. The wait-list control group receives no device during the first 6 weeks and is offered the sensor after the week 6 assessment and data lock, on that day or within 7 business days, to provide access for all eligible participants. Both groups receive the same standardized education and behavioral goal setting during the first 6 weeks. The primary contrast is the incremental device effect during that period. Sensor placement, connection, and safety instructions accompany actual use. Research staff do not adjust medicines based on readings.
Both randomized groups receive the same standardized education and behavioral goal-setting support during the first 6 weeks, regardless of whether a CGM device has been provided. Education covers interpretation of glucose patterns, relationships of meals, activity and sleep with glucose responses, differences in responses to foods, and safe behavioral goals. Safety guidance includes not changing medicines, insulin or food intake solely on the basis of sensor readings. This is a common component, not the randomized difference; it is not postponed until sensor provision in the wait-list control group. Instructions for actual sensor placement, application connection, and device safety are distinguished from this common education.
Both randomized groups receive the same background program beginning at the first screening visit, which may precede randomization: PASTA application guidance, the commercially available AI Diet dietary assessment and feedback provided through Kakao Healthcare's PASTA application, using the existing 10 dietary categories and risk-stage table without modification, CancerFree prevention information, assistance with digital skills, and basic health counseling. Standardized education and behavioral goal setting are also common to both groups during the first 6 weeks. Personal glucose-linked functions become available only when a sensor is provided; actual placement, connection, and device safety instructions accompany device use. The common background program has no separate untreated comparator in this study.
Dietary Self-Management Score at Week 6
Study-specific mean of three adapted items: healthy eating, healthy eating plan adherence, and vegetable consumption. Items 1 and 3 recall the past 7 days; item 2 recalls average weekly practice over the past month. Items and mean range 0-7; higher scores indicate more frequent self-management. No reverse scoring. With one missing item, use the mean of two; with two or more missing, the score is missing. Compare week 6 scores with adjustment for the pre-allocation score on the randomization date, diabetes-status stratum, and enrollment location. If screening occurred earlier, repeat all four dietary items before allocation; use the first three for this baseline. This adapted score is not an unchanged validated scale. If ill in the most recent 7 days, use the preceding 7 days without illness for 7-day items.
Time frame: Week 6 after the actual randomization date (Day 0); assessment window: Days 35-49.
Average Weekly PASTA Application Login Days
Mean number of days per week with a login to the PASTA digital health application, from the actual randomization date (Day 0) through the week 6 assessment (range 0-7 days/week; higher values indicate more frequent use). Participants with confirmed non-installation or no use are assigned zero; records unavailable because of data transfer failure or withdrawn data permission are treated as missing. Glucose-linked functions are available only to the device group before week 6, which is considered when interpreting between-group differences.
Time frame: From the actual randomization date (Day 0) through the week 6 assessment (Days 35-49).
Body Weight at Week 6
Body weight in kilograms, measured at the study visit. The week 6 value is compared between randomized groups with adjustment for baseline body weight, diabetes-status stratum, and enrollment location. Baseline is the pre-allocation measurement from the first screening visit.
Time frame: Week 6 after the actual randomization date (Day 0); assessment window: Days 35-49.
Waist Circumference at Week 6
Waist circumference in centimeters, measured at the study visit. The week 6 value is compared between randomized groups with adjustment for baseline waist circumference, diabetes-status stratum, and enrollment location. Baseline is the pre-allocation measurement from the first screening visit.
Time frame: Week 6 after the actual randomization date (Day 0); assessment window: Days 35-49.
Systolic Blood Pressure at Week 6
Systolic blood pressure in millimeters of mercury, measured at the study visit. The week 6 value is compared between randomized groups with adjustment for baseline systolic blood pressure, diabetes-status stratum, and enrollment location. Baseline is the pre-allocation measurement from the first screening visit.
Time frame: Week 6 after the actual randomization date (Day 0); assessment window: Days 35-49.
Diastolic Blood Pressure at Week 6
Diastolic blood pressure in millimeters of mercury, measured at the study visit. The week 6 value is compared between randomized groups with adjustment for baseline diastolic blood pressure, diabetes-status stratum, and enrollment location. Baseline is the pre-allocation measurement from the first screening visit.
Time frame: Week 6 after the actual randomization date (Day 0); assessment window: Days 35-49.
Dietary Self-Management Score at Week 12
Mean of the same first three study-specific dietary self-care items used for the primary outcome, ranging from 0 to 7, with higher scores indicating more frequent dietary self-management. If one item is missing, the mean of the two available items is used; if two or more are missing, the score is missing. Exploratory follow-up after both groups have been offered a sensor. Results are described by original randomized group and do not represent a concurrent device-versus-no-device comparison; the primary controlled comparison ends at week 6.
Time frame: Week 12 after the actual randomization date (Day 0); assessment window: Days 77-91.
Body Weight at Week 12
Body weight in kilograms at the week 12 visit. Exploratory follow-up after both groups have been offered a sensor. Results are described by original randomized group and do not represent a concurrent device-versus-no-device comparison; the primary controlled comparison ends at week 6.
Time frame: Week 12 after the actual randomization date (Day 0); assessment window: Days 77-91.
Waist Circumference at Week 12
Waist circumference in centimeters at the week 12 visit. Exploratory follow-up after both groups have been offered a sensor. Results are described by original randomized group and do not represent a concurrent device-versus-no-device comparison; the primary controlled comparison ends at week 6.
Time frame: Week 12 after the actual randomization date (Day 0); assessment window: Days 77-91.
Systolic Blood Pressure at Week 12
Systolic blood pressure in millimeters of mercury at the week 12 visit. Exploratory follow-up after both groups have been offered a sensor. Results are described by original randomized group and do not represent a concurrent device-versus-no-device comparison; the primary controlled comparison ends at week 6.
Time frame: Week 12 after the actual randomization date (Day 0); assessment window: Days 77-91.
Diastolic Blood Pressure at Week 12
Diastolic blood pressure in millimeters of mercury at the week 12 visit. Exploratory follow-up after both groups have been offered a sensor. Results are described by original randomized group and do not represent a concurrent device-versus-no-device comparison; the primary controlled comparison ends at week 6.
Time frame: Week 12 after the actual randomization date (Day 0); assessment window: Days 77-91.
Participants With Adverse Events
Number of participants reporting adverse events during visits or technical support contacts, including skin reactions, dizziness, anxiety, and emergency medical care. Events are recorded with severity, relationship to the intervention, actions taken, and outcome. Device problems and privacy incidents are also recorded as safety-related events.
Time frame: From the first screening visit through the week 12 assessment (Days 77-91 after randomization).
Change in AI Diet Dietary Pattern Category
Proportion of participants whose dietary pattern category assigned by the commercially available AI Diet service in Kakao Healthcare's PASTA application, using the existing 10 dietary categories without modification, differs between baseline and week 6. The full category-to-category transition distribution is also described. This is an exploratory measure of change in categorical assignment and does not imply a change in risk level within an unchanged category.
Time frame: Baseline at the first screening visit to week 6 (Days 35-49 after randomization).
New Diabetes Diagnosis in Linked Health Insurance Records
Exploratory occurrence of a new diabetes diagnosis in National Health Insurance Service records among participants with later separate linkage consent and available records, after the processing route and required approvals are established. Current linkage-plan and follow-up-contact consent alone does not authorize data linkage. Up to five years before the first screening visit assess prior history. Incident events are assessed from randomization (Day 0) to the actual single linkage date after all week 12 visits. Results are described by randomized group with actual observation periods, record availability, and missing data. These optional selected data do not replace the primary randomized comparison.
Time frame: From the actual randomization date (Day 0) to a single linkage after all week 12 visits, within the study period ending September 2028.
New Initiation of Glucose-Lowering Medication or Insulin in Linked Health Insurance Records
Exploratory occurrence of newly initiated glucose-lowering medication or insulin in National Health Insurance Service records among participants with later separate linkage consent and available records, after the processing route and required approvals are established. Current linkage-plan and follow-up-contact consent alone does not authorize data linkage. Up to five years before the first screening visit assess prior history. Incident events are assessed from randomization (Day 0) to the actual single linkage date after all week 12 visits. Results are described by randomized group with actual observation periods, record availability, and missing data. These optional selected data do not replace the primary randomized comparison.
Time frame: From the actual randomization date (Day 0) to a single linkage after all week 12 visits, within the study period ending September 2028.
AI Diet Metabolic Dietary Risk Score at Week 6
Exploratory score derived from the commercially available AI Diet service in Kakao Healthcare's PASTA application. The existing 10 dietary categories and their risk-stage table are used without modification. For each category, the provided stages for obesity, diabetes, hypertension, and hypertriglyceridemia are each coded 1 (lowest) to 4 (highest) and summed for analysis. The attainable total across the existing categories ranges from 4 to 13; higher totals indicate higher combined category-assigned risk stages. The week 6 score is compared between randomized groups with adjustment for the pre-allocation baseline score from the first screening visit, diabetes-status stratum, and initial enrollment location. This sum is not an individual probability of disease and cannot reflect within-category changes when the assigned category remains unchanged.
Time frame: Week 6 after the actual randomization date (Day 0); assessment window: Days 35-49.
Plan to share: No — There is no plan to share individual participant data with external researchers.
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