Evidence map›Paper›PMID 32685581›Full record

ArticleJournal of health economics and outcomes research2019

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.

Mark J Cziraky, Scott Abbott, Matt Nguyen, Kay Larholt, Elizabeth Apgar, Thomas Wasser, Poul Strange, Leon Shi, H Courtenay Harrison, Beverly Everitt and 1 more

Open access · goldAbstract read
In one paragraph

Article in Journal of health economics and outcomes research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Addressing the Burden of Multiple Daily Insulin Injections in Type 2 Diabetes with Insulin Pump Technology: A Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024
    Review
  4. Article
  5. Evaluation of Clinical Outcomes With the V-Go Wearable Insulin Delivery Device in Patients With Type 2 Diabetes.Clinical diabetes : a publication of the American Diabetes Association · 2021
    Article
  6. Article
  7. Effectiveness of V-GoDrugs - real world outcomes · 2020
    Article
  8. Article
  9. Observational
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Mark J CzirakyHealthCore, Inc., Wilmington, DE.
Scott AbbottValeritas, Inc., Bridgewater, NJ.
Matt NguyenValeritas, Inc., Bridgewater, NJ.
Kay LarholtCenter for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA.
Elizabeth ApgarHealthCore, Inc., Wilmington, DE.
Thomas WasserHealthCore, Inc., Wilmington, DE.
Poul StrangeIntegrated Medical Development, LLC, Princeton Junction, NJ.
Leon ShiIntegrated Medical Development, LLC, Princeton Junction, NJ.
H Courtenay HarrisonEndocrinology Consultants, Virginia Beach, VA.
Beverly EverittEndocrinology Consultants, Virginia Beach, VA.
Lynn NowakHealthCore, Inc., Wilmington, DE at the time of the study.
Wilmington University · USHun School of Princeton · USMassachusetts Institute of Technology · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMany patients with type 2 diabetes mellitus (T2DM) do not have adequate glycemic control, leading to poor patient outcomes and high healthcare costs.

objectiveThis 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 real-world, community-based practice setting.

methodsStudy 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).

resultsAnalysis 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).

conclusionsThis 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.

Indexed as

insulininsulin delivery devicepragmatic clinical trialtype 2 diabetesV-Go

Identifiers

PMID32685581
PMCPMC7299448
OpenAlexW2976060740

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.