Development of a New Measure for Assessing Insulin Delivery Device Satisfaction in Patients with Type 1 and Type 2 Diabetes

2015 ◽  
Vol 17 (11) ◽  
pp. 773-779 ◽  
Author(s):  
William H. Polonsky ◽  
Lawrence Fisher ◽  
Danielle Hessler ◽  
Steven V. Edelman
Keyword(s):  
Type 2 Diabetes ◽  
Insulin Delivery ◽  
Delivery Device

PaQ®, a simple 3-day basal/bolus insulin delivery device, in people with type 2 diabetes

2013 ◽  
Author(s):  
J. K. Mader ◽  
L. C. Lilly ◽  
F. Aberer ◽  
J. Pachatz ◽  
S. Korsatko ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Insulin Delivery ◽  
Delivery Device ◽  
Bolus Insulin ◽  
Basal Bolus

scholarly journals OR30-02 Efficacy and Safety Comparison Between U100 Regular Human Insulin and U100 Rapid Acting Insulin When Delivered by a 24 Hour Wearable Insulin Delivery Device in Type 2 Diabetes

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Pablo Mora ◽  
David R Sutton ◽  
Ashwini Gore ◽  
Bantwal S Baliga ◽  
Rebecca Goldfaden, PharmD ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Mixed Model ◽  
Insulin Delivery ◽  
Target Range ◽  
Total Daily Dose ◽  
Efficacy And Safety ◽  
Delivery Device ◽  
Acting Insulin ◽  
The Mean

Abstract Introduction: Increasing insulin prices have led to a renewed debate to determine if Rapid Acting Insulin (RAI) analogs offer an advantage over less expensive Regular Human Insulins (RHI). The steep increase in the cost of RAI has led to rationing of insulin or the total discontinuance of therapy by many patients due to cost. For many, RHI provides a more affordable option for insulin therapy when compared to RAI, especially if the limitations of the insulin profile can be overcome by delivering RHI through continuous subcutaneous insulin infusion (CSII) using a wearable insulin delivery device. To our knowledge, no data exists in a type 2 diabetes (T2D) population comparing RAI to RHI when delivered via CSII. Methods: This 14 week multi-center prospective, randomized parallel, non-inferiority study in a T2D population compared the efficacy and safety of RAI versus RHI when delivered by V-Go®, a 24-hr wearable patch-like insulin delivery device that provides a preset continuous basal rate of insulin and on-demand bolus dosing. This study was conducted in a real-world practice setting under usual standard of care. Glucose lowering agents were to remain stable unless removal warranted due to documented clinically significant hypoglycemia and the only specific guidance for insulin titration was to down-titrate if blood glucose levels were consistently lower than target range. Patients administering RAI with V-Go were randomized 1:1 to continue RAI or to switch to RHI. Primary endpoint assessed non-inferiority for the between group net difference in HbA1c derived from a mixed model analysis. Between group differences from baseline for insulin total daily dose (TDD) and hypoglycemia (based on 7 point glucose profiles) were evaluated as secondary endpoints. Results: One hundred thirteen patients (59 RHI and 54 RAI) were evaluated. Baseline characteristics were similar between cohorts. The mean change in HbA1c with RHI was -0.60% from a baseline of 8.41% vs -0.38% from a baseline of 8.33% with RAI (estimated treatment difference [ETD]: -0.22%; 95% confidence interval [CI] -0.67% to 0.22%; non-inferiority margin<0.4% and p=0.007). The mean change in TDD with RHI was 0.8 U/day from a baseline of 61.0 U/day vs 1.8 U/day from a baseline of 61.3 U/day with RAI (ETD: -1.04 U/day; 95% CI: -3.18 U/day to 1.11 U/day; p=0.92). The absolute change in percent of patients reporting hypoglycemia (≤ 70 mg/dL) from pre-randomization to post-randomization was +5.08% with RHI vs + 5.56% with RAI (ETD: -0.48%; 95% CI: -10.6% to 9.1%; p=0.91). Severe hypoglycemia was not reported in either cohort. Conclusion: Patients with T2D administering RAI with V-Go can safely switch to RHI maintaining similar glycemic control.

scholarly journals 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

2020 ◽  
Vol 8 (2) ◽  
pp. e001832
Author(s):  
Pablo F Mora ◽  
David R Sutton ◽  
Ashwini Gore ◽  
Bantwal Baliga ◽  
Rebecca F Goldfaden ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cost Savings ◽  
Insulin Delivery ◽  
Regular Insulin ◽  
Pharmacy Cost ◽  
Delivery Device ◽  
Primary Analysis ◽  
Open Label ◽  
Acting Insulin

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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