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Table 2 Glycaemic outcomesa for all phases of study

From: Use of a decision support tool and quick start onboarding tool in individuals with type 1 diabetes using advanced automated insulin delivery: a single-arm multi-phase intervention study

 

Run in

Phase 1 intervention

Phase 2 intervention

P value

Phase 2 vs. Phase 1

Mean glucose, mmol/L

8.4 ± 0.8

8.3 ± 0.6

8.5 ± 0.7

0.5

Glucose management indicator, %b

6.9 ± 0.4

6.9 ± 0.2

7 ± 0.3

0.5

Coefficient of variation, %

35.8% ± 5

36.3 ± 4.7

34.2 ± 5

0.08

%time in severe hypoglycemia (< 3 mmol/L/54mg/dl),

0.40 ± 0.40

0.40 ± 0.40

0.10 ± 0.10

0.01

%Time below range (< 3.9 mmol/L/70mg/dl)b

2.1 ± 1.70

2.10 ± 1.30

1.40 ± 1.20

0.04

% Time in tight range (3.9–7.8mmol/70-140mg/dl)

49.7 ± 10.4

50.2 ± 7.2

49.2 ± 7.7

0.55

%Time in range (3.9–10 mmol/L/70-180mg/dl)c

72.2 ± 9.9

72.9 ± 7.8

73.5 ± 8.6

0.84

%Time above range (>10mmol/180mg/dl)

25.7 ± 10.0

25 ± 7.3

25.2 ± 8.5

0.87

%Time in severe hyperglycemia (> 13.9 mmol/L/ > 250mg/dl)

6.4 ± 5.8

6.2 ± 3.9

6.1 ± 4.4

0.91

Total Daily dose, units

51.6 ± 30.4

51.3 ± 29.2

47.1 ± 19.3

0.46

Meal Bolus, units

19.6 (12.4)

19.3 ± 10.9

14.8 ± 8

0.06

Basal insulin, units

23.1 (11.9)

20.1 ± 11.2

16.7 ± 7.8

0.13

Autocorrection, units

8.2 (7.1)

9.7 ± 7.2

10.7 ± 6.3

0.58

Meals per day

5.2 ± 2

5.1 ± 1.8

4.6 ± 1.8

0.32

Carbs per day(g)

174.3 ± 70.7

169.8 ± 71.4

156.8 ± 71.8

0.51

Sensors use %

89.8 ± 11.8

87.6 ± 9.9

88.6 ± 15.6

0.73

% Time in Automodec

94.1 ± 5.7

95.8 ± 6.3

98.1 ± 3.9

0.07

AHCL exits, weekd

1.2 ± 1

1.1 ± 0.90

0.7 ± 0.40

0.05

% of Subjects Automode < 70%

3.8%

1.9%

0%

0.07

  1. aIinternational consensus group targets [14]: TIR (3.9-10mmol/70-180mg/dl) > 70%, TBR (< 3.9mmol/ < 70mg/dl) < 4%, TBR(< 3.0mmol < 54mg/dl) < 1%, TAR (> 10mmol/180mg/dl) < 25%, (> 13.9mmol/250mg/dl) < 5%
  2. b(GMI)Glucose Management Indicator, a measure converting mean sensor glucose into an estimated Hba1c Value [15]
  3. cp value comparing phase 1 to phase 2
  4. dnumber of exits from OL for different reasons per week expressed as average and standard deviation