# InsuTrialKit-Kor — Korean RCT Report

_Generated: 2026-04-28 13:43 KST_

> **연구·교육용. 실제 임상의사결정에 사용 금지.**

## 1. Per-subject outcomes (ADA 2023 14-metric)

| subject_id | TIR_70_180_pct | TBR_lt70_pct | TBR_lt54_pct | TAR_gt180_pct | TAR_gt250_pct | GMI_pct | CV_pct | MAGE_mg_dl | hypo_events_ge15min | sensor_wear_pct | days_with_data |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| SUBJ_01 | 83.03 | 0.48 | 0.11 | 16.49 | 0.1 | 6.83 | 23.5 | 83.26 | 0 | 100 | 13 |
| SUBJ_02 | 72.57 | 0.66 | 0.13 | 26.77 | 0.75 | 7.01 | 24.34 | 91.65 | 0 | 100 | 13 |
| SUBJ_03 | 69.77 | 0.38 | 0.09 | 29.86 | 1.49 | 7.06 | 25.29 | 97.69 | 0 | 100 | 13 |

## 2. Group × Period summary table

| group | n | TIR_mean | TIR_sd | GMI_mean | TBR1_mean | period |
| --- | --- | --- | --- | --- | --- | --- |
| A | 1 | 72.57 |  | 7.01 | 0.66 | post-randomization (full window) |
| B | 2 | 76.4 | 9.376 | 6.945 | 0.43 | post-randomization (full window) |

## 3. Outcome heatmap-ready data (subject × metric)

Columns are normalized 0–100 within each metric for visual heatmap rendering.

| subject_id | TIR_70_180_pct_norm | TBR_lt70_pct_norm | TAR_gt180_pct_norm | GMI_pct_norm | CV_pct_norm |
| --- | --- | --- | --- | --- | --- |
| SUBJ_01 | 100 | 35.7 | 0 | 0 | 0 |
| SUBJ_02 | 21.1 | 100 | 76.9 | 78.3 | 46.9 |
| SUBJ_03 | 0 | 0 | 100 | 100 | 100 |

## 4. Bland-Altman pairs (TIR vs GMI, per-subject)

  - subject=SUBJ_01, mean=44.93, diff=76.20
  - subject=SUBJ_02, mean=39.79, diff=65.56
  - subject=SUBJ_03, mean=38.41, diff=62.71

## 5. CGM data quality — gaps ≥ 30 min

_No gaps ≥ 30 min detected._

## 6. Sample size calculation

- ΔTIR = 5.0%, SD = 12.0%, α = 0.05, power = 0.8
- z_(1-α/2) = 1.96, z_(1-β) = 0.8416
- **N per arm = 91**, total = 182
- Formula: `N/arm = 2*(z_{1-a/2}+z_{1-b})^2 * (SD/delta)^2`

## 7. References

- ADA 2023 Standards of Care, Diabetes Technology chapter
- Battelino T et al., Diabetes Care 2019 / ATTD 2022 consensus on CGM TIR
- Bergenstal RM et al., Diabetes Care 2018 (GMI formula)

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_End of report._