Evidence map›Paper›PMID 33214190›Full record

Trial reportBMJ open diabetes research & care2020

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.

Pablo F Mora, David R Sutton, Ashwini Gore, Bantwal Baliga, Rebecca F Goldfaden, Carla Nikkel, John Sink Ii, Beverley Adams-Huet

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open diabetes research & care, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03495908 (Efficacy and Safety Comparison Between U-100 Regular Human Insulin and Rapid Acting Insulin When Delivered by VGo Wearable Insulin Delivery in Type 2 Diabetes), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 22% 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.

NCT03495908 nacompletednot on this map

Efficacy and Safety Comparison Between U-100 Regular Human Insulin and Rapid Acting Insulin When Delivered by VGo Wearable Insulin Delivery in Type 2 Diabetes

TypeinterventionalSponsorEast Coast Institute for ResearchRan2018 to 2019Enrolled136ConditionsType 2 Diabetes, Type 2 Diabetes MellitusArmsVGo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
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

8 authors at 2 institutions in 1 country.

Pablo F MoraDivision of Endocrinology, Diabetes & Metabolism, The University of Texas Southwestern Medical Center, Dallas, Texas, USA pf_mora@yahoo.com.
David R SuttonNortheast Florida Endocrine and Diabetes Associates, Jacksonville, Florida, USA.
Ashwini GoreJones Center for Diabetes and Endocrine Wellness, Macon, Georgia, USA.
Bantwal BaligaEast Alabama Endocrinology PC, Columbus, Ohio, USA.
Rebecca F GoldfadenEast Coast Institute for Research, LLC, Jacksonville, Florida, USA.
Carla NikkelZealand Pharma US Inc, Boston, Massachusetts, USA.
John Sink IiZealand Pharma US Inc, Boston, Massachusetts, USA.
Beverley Adams-HuetIndependent Statistician, Coppell, Texas, USA.
Diabetes & Endocrine Associates · USThe University of Texas Southwestern Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 NUMBER: NCT03495908.

Indexed as

Diabetes Mellitus, Type 2Wearable Electronic DevicesCost-Benefit AnalysisHumansInsulinInsulin, Short-ActingInsulinInsulin, Short-Actingcosts and cost analysisdiabetes mellitusinsulininsulin infusion systemstype 2

Identifiers

PMID33214190
PMCPMC7678232
OpenAlexW3103413017

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.