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Table 4 Treatment effect between vildagliptin and control groups in patients with T1DM on AHCL illustrating mean difference (95% confidence interval) of glucometrics and glycemic excursions before and at the end of Ramadan

From: Mitigating iftar-related glycemic excursions in adolescents and young adults with type 1 diabetes on MiniMedâ„¢ 780G advanced hybrid closed loop system: a randomized clinical trial for adjunctive oral vildagliptin therapy during Ramadan fasting

Variable

Mean difference (95% CI)

p value

Vildagliptin group (n = 23)

Control group (n = 22)

Average SG (mg/dL)

− 12.5 (− 20.955 to − 1.645)

10.3 (− 1.639 to 22.239)

< 0.001

Average SG (mmol/L)

− 0.6 (− 1.124 to − 0.075)

0.5 (− 0.155 to 1.155)

< 0.001

GMI (eA1C %)

− 0.52 (− 0.864 to 0.176)

0.09 (− 0.405 to 0.585)

< 0.001

GMI (eA1C mmol/moL)

− 5.1 (− 8.874 to − 1.326)

1.2 (− 2.473 to 4.873)

< 0.001

CoV (%)

− 5.2 (− 9.937 to − 0.463)

3.8 (− 1.578 to 9.178)

< 0.001

TIR 70–180 mg/dL (3.9–10 mmol/L) (%)

6.9 (1.797 to 12.003)

0.2 (− 4.807 to 5.207)

< 0.001

TBR < 70 mg/dL (< 3.9 mmol/L) (%)

− 0.3 (− 0.784 to 0.184)

− 0.4 (− 0.915 to 0.115)

0.161

TBR < 54 mg/dL (< 3.0 mmol/L) (%)

0.0 (− 0.076 to 0.076)

0.0 (− 0.066 to 0.066)

1.000

TAR 180–250 mg/dL (10.0–13.9 mmol/L) (%)

− 3.9 (− 6.41 to − 1.39)

0.1 (− 2.346 to 2.546)

< 0.001

TAR > 250 mg/dL (> 13.9 mmol/L) (%)

− 2.7 (− 3.336 to − 2.064)

0.10 (− 0.472 to 0.672)

< 0.001

Total daily dose (U/day)

− 6.4 (− 11.714 to − 1.086)

4.1 (− 1.253 to 9.453)

< 0.001

Bolus amount (U/day)

− 4.5 (− 8.064 to − 0.936)

5.9 (1.333 to 10.467)

< 0.001

Auto correction amount (day)

− 1.6 (− 3.372 to − 0.828)

0.8 (− 0.054 to 1.65)

< 0.001

Auto Basal/Basal amount (day)

− 1.9 (− 5.583 to 1.783)

− 1.8 (− 5.931 to 2.331)

0.857

BG at the start of the meal (mg/dL)

− 5.1 (− 24.218 to 14.018)

− 6.3 (− 23.75 to 11.15)

0.643

BG at the start of the meal (mmol/L)

− 0.3 (− 1.356 to 0.756)

− 0.3 (− 1.268 to 0.668)

1.000

BG at 60 min from the start of the meal (mg/dL)

− 19.1 (− 37.486 to − 0.714)

5.7 (− 14.605 to 26.005)

< 0.001

BG at 60 min from the start of the meal (mmol/L)

− 1.1 (− 2.115 to − 0.085)

0.3 (− 0.809 to 1.409)

< 0.001

BG at 120 min from the start of the meal (mg/dL)

− 30.3 (− 57.928 to − 2.672)

− 2.9 (− 22.789 to 16.989)

< 0.001

BG at 120 min from the start of the meal (mmol/L)

− 1.7 (− 3.209 to − 0.191)

− 0.2 (− 1.282 to 0.882)

< 0.001

BG at 180 min from the start of the meal (mg/dL)

− 34.4 (− 58.527 to − 10.27)

− 11.1 (− 32.418 to 0.218)

< 0.001

BG at 180 min from the start of the meal (mmol/L)

− 1.9 (− 3.244 to − 0.556)

− 0.6 (− 1.769 to 0.569)

< 0.001

Carbohydrates (g/day)

55.4 (37.11 to 73.69)

62.3 (46.53 to 79.06)

0.194

ICR (g)

1.7 (− 0.021 to 3.421)

− 3.7 (− 5.378 to − 2.022)

< 0.001

  1. T1DM type 1 diabetes mellitus, AHCL Advanced Hybrid Closed Loop System, SG sensor glucose, GMI glucose management indicator, eA1C estimated A1C, CoV coefficient of variation, BG blood glucose, TIR time in range, TBR time below range, TAR time above range, ICR insulin to carb ratio