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Table 3 Comparison between vildagliptin and control groups as regards MiniMedâ„¢ 780G glucometrics and glycemic excursions before and at the end of Ramadan among the enrolled patients with T1DM

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

Vildagliptin group

p valuea

Control group

p valuea

p valueb

Before Ramadan (n = 25)

End of Ramadan (n = 23)

Before Ramadan (n = 25)

End of Ramadan (n = 22)

Average SG (mg/dL)

151.4 ± 20.5

140.1 ± 12.5

0.025

157.9 ± 22.3

168.2 ± 19.6

0.113

< 0.001

Average SG (mmol/L)

8.4 ± 1.1

7.8 ± 0.7

0.032

8.8 ± 1.2

9.3 ± 1.1

0.139

< 0.001

GMI (eA1C %)

6.94 ± 0.63

6.42 ± 0.58

0.005

6.88 ± 0.55

6.97 ± 1.1

0.695

0.045

GMI (eA1C mmol/moL)

52.2 ± 7.3

47.1 ± 5.9

0.015

51.6 ± 6.8

52.8 ± 6.1

0.481

0.002

CoV (%)

37.0 ± 9.4

31.8 ± 7.1

0.035

37.8 ± 9.1

41.6 ± 9.8

0.194

< 0.001

TIR 70–180 mg/dL (3.9–10 mmol/L) (%)

77.8 ± 9.6

84.7 ± 8.3

0.016

78.9 ± 9.1

79.1 ± 8.5

0.687

0.036

TBR < 70 mg/dL (< 3.9 mmol/L) (%)

3.2 ± 0.8

2.9 ± 0.9

0.212

3.5 ± 1.0

3.1 ± 0.8

0.112

0.428

TBR < 54 mg/dL (< 3.0 mmol/L) (%)

0.3 ± 0.14

0.3 ± 0.13

0.875

0.3 ± 0.12

0.3 ± 0.11

0.971

0.986

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

13.6 ± 5.1

9.7 ± 3.6

0.003

13.1 ± 4.2

13.2 ± 4.4

0.829

0.005

TAR > 250 mg/dL (> 13.9 mmol/L) (%)

5.1 ± 1.3

2.4 ± 0.9

< 0.001

4.5 ± 1.0

4.3 ± 1.1

0.479

< 0.001

Total daily dose (U/day)

49.8 ± 10.2

43.4 ± 8.4

0.023

48.3 ± 8.9

52.4 ± 9.9

0.164

0.002

Bolus amount (U/day)

27.6 ± 6.7

23.1 ± 5.8

0.015

26.7 ± 7.3

32.6 ± 8.7

0.187

< 0.001

Auto correction amount (day)

6.7 ± 1.5

5.1 ± 1.2

< 0.001

6.3 ± 1.4

7.1 ± 1.6

0.084

< 0.001

Auto Basal/Basal amount (day)

22.2 ± 7.8

20.3 ± 4.8

0.292

21.6 ± 6.8

19.8 ± 7.7

0.397

0.689

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

117.1 ± 36.3

112.0 ± 30.7

0.213

120.8 ± 29.2

114.5 ± 32.1

0.257

0.584

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

6.5 ± 2.0

6.2 ± 1.7

0.512

6.7 ± 1.6

6.4 ± 1.8

0.548

0.697

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

178.2 ± 37.4

159.1 ± 26.3

0.041

182.6 ± 35.1

188.3 ± 36.3

0.518

0.005

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

9.9 ± 2.1

8.8 ± 1.4

0.036

10.1 ± 1.9

10.4 ± 2.0

0.624

0.004

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

207.5 ± 51.3

177.2 ± 45.7

0.033

219.3 ± 36.2

216.4 ± 33.7

0.715

0.002

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

11.5 ± 2.8

9.8 ± 2.5

0.032

12.2 ± 2.0

12.0 ± 1.8

0.728

0.003

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

183.7 ± 46.1

149.3 ± 38.4

0.005

187.8 ± 35.8

176.7 ± 39.1

0.357

0.021

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

10.2 ± 2.6

8.3 ± 2.1

0.006

10.4 ± 1.9

9.8 ± 2.2

0.341

0.025

Carbohydrates (g/day)

156.2 ± 28.7

211.6 ± 35.3

< 0.001

161.2 ± 25.3

226.5 ± 39.2

< 0.001

0.214

ICR (g)

10.2 ± 2.6

11.9 ± 3.4

0.063

10.8 ± 3.0

7.1 ± 2.9

< 0.001

< 0.001

Smart gaurd/week auto mode (%)

95.5 ± 4.1

97.4 ± 5.7

0.194

96.1 ± 4.4

97.7 ± 4.8

0.167

0.412

Sensor wear (%)

96.8 ± 3.6

97.1 ± 4.5

0.815

95.7 ± 3.9

97.8 ± 4.1

0.085

0.625

Exit from AHCL per patient (n/week)

1.3 ± 0.6

1.1 ± 0.4

0.186

1.2 ± 0.5

1.4 ± 0.7

0.174

0.094

BG calibration (n/day)

3.5 ± 0.6

3.8 ± 0.7

0.221

3.4 ± 0.6

3.7 ± 0.6

0.125

0.616

Set change (n of days)

3.3 ± 1.1

3.6 ± 1.0

0.307

3.4 ± 1.2

3.5 ± 1.1

0.726

0.759

Reservoir change (n of days)

3.4 ± 0.7

3.5 ± 0.5

0.568

3.1 ± 0.5

3.3 ± 0.6

0.218

0.261

Number of days fasting completed

–

27.8 ± 0.5

–

–

28.0 ± 0.6

–

0.217

  1. T1DM type 1 diabetes mellitus, 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
  2. aP value was obtained from paired-samples t test
  3. bP value was obtained using Analysis of covariance (ANCOVA)