Multicenter Real-World Assessment of the Effectiveness of V-Go Wearable Insulin Delivery Device in Adult Patients with Type 2 Diabetes (ENABLE Study): A Retrospective Analysis

Figures & data

Table 1 Baseline Patient Demographics and Characteristics

Variable
Number of patients	283
Age (yrs)	60 ± 11
Sex – Male	130 (46)
Race
Caucasian	222 (78)
Black or African American	52 (18)
Other	9 (4)
Ethnicity
Hispanic	14 (5)
Not Hispanic	247 (87)
Not reported	22 (8)
Weight (lbs)	221 ± 45
BMI (kg/m^2)	34.8 ± 6.7
A1C (%)	9.18 ± 1.51
A1C (%) by duration of diabetes^a
0–5 years (n=16)	9.74 ± 1.64
5–10 years (n=37)	9.34 ± 1.39
10–15 years (n=49)	9.23 ± 1.45
15–20 years (n=38)	9.32 ± 1.64
>20 years (n=46)	8.84 ± 1.58
A1C distribution
<8.0%	69 (24)
≤9.0%	154 (54)
>9.0%	129 (46)
Insulin TDD (U/day)	76 ± 47
Insulin TDD range (U/day)	14–300
Insulin TDD (U/day) by diabetes duration
0–5 years	66 ± 44
5–10 years	82 ± 48
10–15 years	78 ± 50
15–20 years	60 ± 33
>20 years	72 ± 50

Notes: Data are n, n (%) or mean ± SD unless otherwise noted. ^aDuration of diabetes was not known for all patients.

Table 2 Baseline Diabetes Regimen

Diabetes Regimen	N (%)
Baseline Insulin Regimen
Basal-Bolus	186 (66)
Basal only	64 (23)
Premix	15 (5)
Basal-plus	6 (2)
Other^a	12 (4)
Prescribed NIGLM^b	220 (78)
Metformin	116 (41)
GLP-1 Receptor Agonist	80 (28)
SGLT-2 Inhibitor	61 (22)
DPP-4 Inhibitor	40 (14)
Sulfonylurea	35 (12)
TZD	15 (5)
DPP-4 Inhibitor/Metformin	8 (3)
SGLT-2 Inhibitor/Metformin	9 (3)

Notes: ^aPrandial n=5; premix/prandial n=3; basal/premix n=4. ^bNIGLM (Non-insulin glucose-lowering medications) prescribed in ≤1% of population not shown. % incidence calculated across total population.

Figure 1 Mean changes in A1C (A) and insulin TDD (B) over time with V-Go use compared to baseline. A1C (%) and prescribed TDD (U/day) were both significantly reduced (P<0.0001 at 3 and 7 months compared to baseline). N= 283.

Abbreviations: A1C, glycated hemoglobin; TDD, total daily dose of insulin; U, units.

Figure 2 Achievement of A1C targets thresholds at baseline and after 7 months of V-Go use. Percent of patient achievement for A1C target thresholds (<7%, <8% and ≤9%) are shown to the left of dotted line. Percentages are cumulative and represent the total percentage of patients achieving each specific target threshold. A1C values >9% indicate a negative performance indicator for diabetes care and are associated with a higher risk for complications and comorbidities. The percentage of patients in this high-risk threshold are shown to the right of the dotted line. Significant (P<0.001) increases were observed in the percent of patients achieving A1C targets of ≤9% and <8%, and a significant (P<0.001) decrease in the percent of patient considered high risk (A1C>9.0%) after 7 months of V-Go use.

Abbreviation: A1C, glycated hemoglobin.

Table 3 Changes in A1C and TDD in Population by Baseline Insulin Regimen Prior to V-Go

Variable	Basal-Bolus	Basal Only	Premix
Number of Patients	186	64	15
Glycemic Control
Baseline A1C, %	9.07 ± 0.11	9.35 ± 0.19	9.59 ± 0.42
3 mo change in A1C	−0.99 ± 0.11*	−1.16 ± 0.18*	−0.38 ± 0.30
7 mo change in A1C	−1.05 ± 0.12*	−1.02 ± 0.23*	−0.86 ± 0.36^†
Insulin Total Daily Dose
Baseline TDD (U/day)	84 ± 3	47 ± 3	104 ± 18
3 mo change in TDD	−27 ± 4*	16 ± 5*	−40 ± 15^†
7 mo change in TDD	−24 ± 4*	23 ± 5*	−35 ± 14^†

Notes: *P<0.0001, ^†P<0.05. Data are pooled mean ± SE.

Table 4 Changes in A1C and TDD in Basal-Bolus Population Based on Baseline Insulin TDD Tertiles

Variable	Insulin TDD Tertile 1 < 60 U	Insulin TDD Tertile 2 60–90 U	Insulin TDD Tertile 3 >90 U
Number of Patients	64	59	63
Glycemic Control
Baseline A1C, %	9.12 ± 0.19	8.78 ± 0.17	9.31 ± 0.20
7 mo change in A1C	−1.02 ± 0.19*	−0.80 ± 0.20*	−1.21 ± 0.19*
Insulin Total Daily Dose
Baseline TDD (U/day)	46 ± 1	72 ± 1	134 ± 6
7 mo change in TDD	4 ± 2	−15 ± 2*	−63 ± 6*

Notes: *P<0.0001. Data are pooled mean ± SE.

Figure 3 Mean changes in A1C and insulin TDD over time with V-Go use based on duration of diabetes. Patients with known duration of diabetes (N=186) were stratified based on 5 diabetes duration strata (n= 16, 37, 49, 38 and 46, respectively). Reductions in A1C (%) were significant (*P< 0.01) at both 3 and 7 months across all strata. Changes in TDD of insulin (U/day) reflect the difference in prescribed TDD after a mean of 7 months of V-Go use compared to prescribed TDD prior to V-Go use Reductions in TDD were observed across 4 of the 5 strata with significant (*P<0.01, ^†P<0.05) reductions observed in the two strata (5 to 10-year duration and 10 to 15-year duration) with the highest prescribed TDD at baseline.

Abbreviations: A1C, glycated hemoglobin; TDD, total daily dose of insulin; U, units.