Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 16 of 16

List	Outcome	Time frame	Description
Primary	Dietary Self-Management Score at Week 6	Week 6 after the actual randomization date (Day 0); assessment window: Days 35-49.	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.
Secondary	Average Weekly PASTA Application Login Days	From the actual randomization date (Day 0) through the week 6 assessment (Days 35-49).	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with confirmed non-installation or no use are assigned zero; records unavailable because of data transfer failure or withdrawn data permission are treated as missing.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.
Secondary	Body Weight at Week 6	Week 6 after the actual randomization date (Day 0); assessment window: Days 35-49.	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.
Secondary	Waist Circumference at Week 6	Week 6 after the actual randomization date (Day 0); assessment window: Days 35-49.	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.
Secondary	Systolic Blood Pressure at Week 6	Week 6 after the actual randomization date (Day 0); assessment window: Days 35-49.	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.
Secondary	Diastolic Blood Pressure at Week 6	Week 6 after the actual randomization date (Day 0); assessment window: Days 35-49.	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.
Other	Dietary Self-Management Score at Week 12	Week 12 after the actual randomization date (Day 0); assessment window: Days 77-91.	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.
Other	Body Weight at Week 12	Week 12 after the actual randomization date (Day 0); assessment window: Days 77-91.	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.
Other	Waist Circumference at Week 12	Week 12 after the actual randomization date (Day 0); assessment window: Days 77-91.	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.
Other	Systolic Blood Pressure at Week 12	Week 12 after the actual randomization date (Day 0); assessment window: Days 77-91.	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.
Other	Diastolic Blood Pressure at Week 12	Week 12 after the actual randomization date (Day 0); assessment window: Days 77-91.	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.
Other	Participants With Adverse Events	From the first screening visit through the week 12 assessment (Days 77-91 after randomization).	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.
Other	Change in AI Diet Dietary Pattern Category	Baseline at the first screening visit to week 6 (Days 35-49 after randomization).	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.
Other	New Diabetes Diagnosis in Linked Health Insurance Records	From the actual randomization date (Day 0) to a single linkage after all week 12 visits, within the study period ending September 2028.	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.
Other	New Initiation of Glucose-Lowering Medication or Insulin in Linked Health Insurance Records	From the actual randomization date (Day 0) to a single linkage after all week 12 visits, within the study period ending September 2028.	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.
Other	AI Diet Metabolic Dietary Risk Score at Week 6	Week 6 after the actual randomization date (Day 0); assessment window: Days 35-49.	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.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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