Regular Insulin Administered With the V-Go Disposable Insulin Delivery Device in a Clinical Diabetes Setting: A Retrospective Analysis of Efficacy and Cost

Sutton, David; Higdon, Charissa; Carmon, Mark; Abbott, Scott

doi:10.2337/cd16-0021

Cited by 4 publications

(6 citation statements)

References 13 publications

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“…Patients in the V-Go group reported a 24% reduction in TDD U/day and a 25% reduction in TDD U/kg while patients in the STO group reported no changes in TDD. Our observation of decreased insulin utilization after initiation of V-Go is consistent with previous research 8, [18][19][20]22 and supports the theory that continuous insulin infusion may be more efficient than insulin delivery via single or multiple injections. 14,18 Patients in the V-Go as well as the STO group were generally satisfied with their insulin delivery device at baseline and EOS, with average TRIM-Diabetes Device scores in the 70s and 80s on a 100-point scale.…”

Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 91%

“… 7 , 8 , 18 , 19 The mean reduction in HbA1c levels (−1.0%) in the V-Go group was within the range of decreases reported in prior studies of patients initiating V-Go after similar follow-up periods (range −0.8% to −2.0%). 17 – 20 , 22 These prior studies were retrospective and relied on HbA1c data from electronic medical records rather than collected prospectively as in the current study. The V-Go population in the current study also included patients with poorly controlled diabetes (ie, baseline HbA1c levels above 9.5%), which may be more difficult to treat than well-controlled diabetes.…”

Section: Discussionmentioning

confidence: 99%

“…The V-Go device has demonstrated efficacy in controlled clinical settings, 14 and results of small case studies and nonrandomized observational studies have demonstrated effectiveness in everyday usage. 15 , 16 Following initiation of insulin treatment with V-Go, significant improvements were observed in glycemic control, 7 , 8 , 17 – 22 as well as reductions in insulin requirements 8 , 17 , 18 , 20 , 21 and lower diabetes-related treatment costs. 7 , 18 , 19 While these effects were observed in a variety of patient populations and settings, all of these studies were retrospective designs and thus were limited in their analysis by reliance on medical records and potential selection bias towards patients with available data.…”

Section: Introductionmentioning

confidence: 99%

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A Pragmatic Clinical Trial to Compare the Real-World Effectiveness of V-Go versus Standard Delivery of Insulin in Patients with Advanced Type 2 Diabetes

Cziraky

Abbott²,

Nguyen³

et al. 2019

JHEOR

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Background: Many patients with type 2 diabetes mellitus (T2DM) do not have adequate glycemic control, leading to poor patient outcomes and high healthcare costs. Objective: This prospective pragmatic clinical trial evaluated V-Go, a wearable insulin delivery device, compared with standard treatment optimization (STO) among insulin-treated patients with T2DM in a realworld, community-based practice setting. Methods: Study sites, rather than individual patients, were randomized to V-Go or STO via cluster randomization. Patients were treated according to routine clinical practice and followed up to 4 months. T2DM medications and supplies were purchased utilizing usual insurance and co-pay systems. The primary analysis was an unadjusted treatment group comparison of glycosylated hemoglobinA1c (HbA1c) change from baseline to end of study (EOS). A cost of therapy analysis was completed on patients who had received comparable baseline T2DM treatment with multiple daily basal-bolus insulin injections (MDI). Results: Analysis included 415 patients (169 V-Go, 246 STO) enrolled from 52 US sites. Mean baseline HbA1c (9.6%) was higher in V-Go (9.9%, range 8.0% - 14.2%) than STO (9.3%, range 7.9% - 13.9%, p <.001). HbA1c decreased from baseline to EOS in both V-Go (-1.0%, p<.001) and STO (-0.5%, p<.001); V-Go had significantly larger decrease (p=.002). V-Go had a significant reduction (p<.001) in mean insulin total daily dose (TDD; 0.76 U/kg baseline, 0.57 U/kg EOS), not seen in STO (0.72 U/kg baseline and EOS). The MDI group included 95 (56.2%) V-Go and 113 STO (45.9%) patients. Mean baseline HbA1c was significantly higher in V-Go (9.9%) than STO (9.4%). V-Go also experienced larger decrease in HbA1c from baseline (-1.0%) than STO (-0.36%) (p=.006) with a decrease in TDD, while STO TDD remained unchanged. EOS mean per patient per day cost of diabetes treatment was lower for V-Go ($30.59) vs STO ($32.20) (p=.006). V-Go was more cost effective than STO ($24.02 per 1% drop in HbA1c vs $58.86, respectively). Conclusions: This pragmatic clinical trial demonstrated improved HbA1c levels, lower cost, and decreased insulin dose in patients with T2DM initiating V-Go vs STO in a real-world community-based practice setting. Observed baseline HbAlc indicated use of V-Go in more difficult to manage diabetes patients.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

A Pragmatic Clinical Trial to Compare the Real-World Effectiveness of V-Go versus Standard Delivery of Insulin in Patients with Advanced Type 2 Diabetes

Cziraky

Abbott²,

Nguyen³

et al. 2019

JHEOR

Self Cite

View full text Add to dashboard Cite

show abstract

“… 21 24–28 Although the V-Go device is currently indicated for use with U-100 RAI analogues, studies have shown that U-100 HRI is stable in V-Go devices 29 with demonstrated efficacy and safety in a small retrospective evaluation. 30 …”

Section: Introductionmentioning

confidence: 99%

Efficacy, safety and cost-effectiveness comparison between U-100 human regular insulin and rapid acting insulin when delivered by V-Go wearable insulin delivery device in type 2 diabetes

Mora

Sutton

Gore³

et al. 2020

BMJ Open Diab Res Care

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IntroductionWe compared the efficacy and safety of human regular insulin (HRI) versus rapid-acting insulin (RAI) in a type 2 diabetes population already using the V-Go insulin delivery device.Research design and methodsThis was a 14-week, multicenter, randomized, open-label, parallel-group, phase IV, non-inferiority study. Patients ≥21years of age, with inadequately controlled type 2 diabetes who were currently using the V-Go insulin delivery system with RAI, with glycated hemoglobin (HbA1c) ≥6.5% (≥48 mmol/L) to ≤12.5% (≤108 mmol/L) were randomized 1:1 to RAI continuation or switch to HRI. The primary outcome was estimated treatment difference (ETD) in HbA1c least-squares mean change from baseline at 14 weeks (prespecified non-inferiority hypothesis with 95% CI upper limit <0.4%). Primary analysis was by per protocol (PP); safety analysis was by intention to treat.ResultsWe randomized 136 patients to continued RAI treatment (n=67) or HRI (n=69); 113 patients were included in the PP analysis (RAI, n=54; HRI, n=59). Mean change in HbA1c from baseline to study end was −0.60±1.1% (95% CI −0.90 to –0.29); −6.6±12.0 mmol/mol (95% CI −9.8 to −3.2) with HRI treatment and −0.38±1.3% (95% CI −0.70 to –0.05); −4.2±14.2 mmol/mol (95% CI −7.7 to −0.5) with RAI treatment, with ETD of −0.22% (95% CI −0.67 to 0.22); −2.4 mmol/mol (95% CI −7.3 to 2.4), p=0.007, confirming non-inferiority of HRI to RAI. No between-group differences in changes in total daily insulin doses, number of hypoglycemic values (≤70 mg/dL (≤39 mmol/L) or body weight were observed. No severe hypoglycemic events were reported. Direct pharmacy cost savings (−US$265.85; 95% CI −US$288.60 to −US$243.11; p<0.0001) were observed with HRI treatment.ConclusionsIndividuals with type 2 diabetes requiring insulin can be treated with V-Go wearable insulin delivery device using HRI, safely and effectively, and potentially at a much lower cost compared with RAI, which can lead to improved access to insulin therapy for these individuals.Trial registration numberNCT03495908.

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Addressing the Burden of Multiple Daily Insulin Injections in Type 2 Diabetes with Insulin Pump Technology: A Narrative Review

Brixner,

Edelman,

Sieradzan

et al. 2024

Diabetes Ther

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The growing prevalence of type 2 diabetes (T2D) remains a leading health concern in the US. Despite new medications and technologies, glycemic control in this population remains suboptimal, which increases the risk of poor outcomes, increased healthcare resource utilization, and associated costs. This article reviews the clinical and economic impacts of suboptimal glycemic control in patients on basal-bolus insulin or multiple daily injections (MDI) and discusses how new technologies, such as tubeless insulin delivery devices, referred to as "patch pumps", have the potential to improve outcomes in patients with T2D.

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Regular Insulin Administered With the V-Go Disposable Insulin Delivery Device in a Clinical Diabetes Setting: A Retrospective Analysis of Efficacy and Cost

Cited by 4 publications

References 13 publications

A Pragmatic Clinical Trial to Compare the Real-World Effectiveness of V-Go versus Standard Delivery of Insulin in Patients with Advanced Type 2 Diabetes

A Pragmatic Clinical Trial to Compare the Real-World Effectiveness of V-Go versus Standard Delivery of Insulin in Patients with Advanced Type 2 Diabetes

Efficacy, safety and cost-effectiveness comparison between U-100 human regular insulin and rapid acting insulin when delivered by V-Go wearable insulin delivery device in type 2 diabetes

Addressing the Burden of Multiple Daily Insulin Injections in Type 2 Diabetes with Insulin Pump Technology: A Narrative Review

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