Table 2.
Primary Outcomes: Glucose Regulation
| TRE |
SOC |
Between Groups | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Outcomes | Baseline | 3-Month | Delta (95% CI) | Percent Change | Baseline | 3-Month | Delta (95% CI) | Percent Change | Delta TRE-SOC | Percent Change | |
|
| |||||||||||
| HbA1c, % | 5.87 (0.34) | 5.75 (0.31) | −0.12 (−0.19 to −0.05) |
−2.0% | 5.86 (0.27) | 5.84 (0.29) | −0.02 (−0.09 to 0.04) |
−0.3% | −0.10 (−0.19 to −0.003) |
−1.7% | |
| Fasting Glucose | |||||||||||
| mmol/L | 5.76 (0.57) | 5.49 (0.52) | −0.27 (−0.42 to 0.12) |
−4.7% | 5.82 (−0.67) | 5.73 (−0.62) | −0.08 (−0.25 to 0.09) |
−1.4% | −0.18 (−7.32 to 0.65) |
−3.3% | |
| mg/dL | 103.78 (10.20) | 98.94 (9.30) | −4.83 (−7.48 to −2.19) |
104.83 (12.02) | 103.33 (11.25) | −1.50 (−4.54 to 1.54) |
−3.33 (−7.32 to 0.65) |
||||
| Fasting Insulin | |||||||||||
| pmol/L | 124.18 (96.05) | 104.24 (58.06) | −20.00 (−44.38 to 4.44) |
−16.1% | 117.37 (57.64) | 109.04 (69.10) | −8.40 (−24.10 to 7.36) |
−7.2% | −11.60 (−40.28 to 17.08) |
−8.9% | |
| mlU/L | 17.88 (13.83) | 15.01 (8.36) | −2.88 (−6.39 to 0.64) |
16.90 (8.30) | 15.70 (9.95) | −1.21 (−3.47 to 1.06) |
−1.67 (−5.80 to 2.46) |
||||
| HOMA-IR, A.U. | 4.61 (3.51) | 3.72 (2.24) | −0.89 (−1.93 to 0.05) |
−19.3 | 4.44 (2.48) | 4.06 (2.65) | −0.38 (−1.07 to 0.31) |
−8.6% | −0.51 (−1.66 to 0.65) |
−10.7% | |
| CGM Mean Glucose (mmol/L) | |||||||||||
| mmol/L | 5.64 (0.51) | 5.52 (0.62) | −0.13 (−0.29 to 0.04) |
−2.2% | 5.65 (0.63) | 5.76 (0.58) | 0.11 (−0.07 to 0.29) |
+1.9% | −0.24 (−0.48 to 0.01) |
−4.1% | |
| mg/dL | 101.68 (9.19) | 99.41 (11.24) | −2.26 (−5.27 to 0.75) |
101.81 (11.36) | 103.79 (10.50) | 1.98 (−1.33 to 5.30) |
−4.25 (−8.68 to 0.18) |
||||
| CGM CONGA, A.U. | 19.96 (4.34) | 18.49 (4.67) | −1.47 (−2.53 to −0.41) |
−7.4% | 18.89 (4.51) | 18.95 (4.85) | 0.06 (−0.99 to 1.11) |
+0.3% | −1.53 (−3.00 to −0.06) |
−7.7% | |
| CGM MODD | |||||||||||
| mmol/L | 0.98 (0.29) | 0.86 (0.24) | −0.10 (−0.16 to 0.05) |
−10.8% | 0.89 (0.20) | 0.92 (0.26) | 0.03 (−0.03 to 0.09) |
+3.3% | −0.13 (−0.22 to −0.05) |
−14.1% | |
| mg/dL | 17.71 (5.31) | 15.56 (4.40) | −1.89 (−2.89 to 0.88) |
16.03 (3.60) | 16.56 (4.77) | 0.53 (−0.58 to 1.64) |
−2.42 (−3.90 to −0.93) |
||||
Data displayed as Mean (SD) and Mean (95% Confidence Interval) for delta values. Paired t-tests were used to assess within-group changes and Mixed ANOVAs were used to assess changes between TRE and SOC (time x group) with age as a covariate. N=54 per group for all outcomes except for the CGM measurements: TRE n=52, SOC n= 53. There was no pattern of missingness between groups (Supplemental Table 2). TRE = time-restricted eating, SOC = standard of care, HbA1c = hemoglobin A1c (glycated hemoglobin), HOMA-IR = homeostasis model assessment of insulin resistance, CGM = continuous glucose monitor, GMI = glucose management indicator (short-term CGM estimate of HbA1c), CONGA = continuous overall net glycemic action, A.U. = arbitrary units, MODD = mean of daily differences.