Evidence map›Paper›PMID 28918652›Full record

Trial reportJournal of diabetes science and technology2018

Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes.

Eric Zijlstra, Marek Demissie, Tina Graungaard, Tim Heise, Leszek Nosek, Bruce Bode

3 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of diabetes science and technology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 6% 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.

NCT01999322 phase3completednot on this map

A 6-week Randomised, Double-blind, Parallel-group Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes

TypeinterventionalSponsorNovo Nordisk A/SRan2013 to 2014Enrolled37ConditionsDiabetes, Diabetes Mellitus, Type 1ArmsFaster-acting insulin aspart, insulin aspart
NCT02825251 phase3completednot on this map

Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes

TypeinterventionalSponsorNovo Nordisk A/SRan2016 to 2017Enrolled472ConditionsDiabetes, Diabetes Mellitus, Type 1ArmsFaster-acting insulin aspart, insulin aspart
NCT03554486 phase4completednot on this map

Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy: To Assess How the 670G System Adapts to the Introduction of Fiasp® Insulin

TypeinterventionalSponsorStanford UniversityRan2018 to 2019Enrolled27ConditionsDiabetes Mellitus, Type 1ArmsFiasp, Novolog
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Fast-Acting Insulin Aspart Use with the MiniMedDiabetes technology & therapeutics · 2021
    Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Review
  10. Improvements in Glycemic Control Achieved by Altering the tDiabetes therapy : research, treatment and education of diabetes and related disorders · 2021
    Article
  11. Article
  12. Review
  13. Review
  14. Fast-Acting Insulin Aspart: The Rationale for a New Mealtime Insulin.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019
    Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 3 countries.

Eric Zijlstra1 Profil, Neuss, Germany.
Marek Demissie2 Novo Nordisk A/S, Søborg, Denmark.
Tina Graungaard2 Novo Nordisk A/S, Søborg, Denmark.
Tim Heise1 Profil, Neuss, Germany.
Leszek Nosek1 Profil, Neuss, Germany.
Bruce Bode3 Atlanta Diabetes Associates, Atlanta, GA, USA.
Profil Institute for Metabolic Research · DENovo Nordisk (Denmark) · DKAtlanta Diabetes Associates · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUltra-fast-acting insulins, such as fast-acting insulin aspart (faster aspart), have pharmacokinetic properties that may be advantageous for patients using continuous subcutaneous insulin infusion (CSII), provided that they are compatible with and safe to use in CSII.

methodsRandomized, double-blind, parallel-group, actively controlled trial evaluating compatibility, efficacy, and safety of faster aspart in adults with type 1 diabetes using their own MiniMed Paradigm pump with Quick-Set or Silhouette infusion sets. Following run-in, subjects were randomized (2:1) to faster aspart (n = 25) or insulin aspart (n = 12) for 6 weeks. Primary endpoint was the number of microscopically confirmed episodes of infusion-set occlusions.

resultsNo microscopically confirmed episodes of infusion-set occlusions were observed in either arm. Seven possible infusion-set occlusions were reported by five subjects (all faster aspart); none were prompted by a plug observed by the subject (prompted by unexplained hyperglycemia [n = 6] or leakage [n = 1]) and none were confirmed. Macroscopic and microscopic evaluation showed no color change or particle/crystal formation in the infusion sets. Premature infusion-set changes were reported in 44% and 16.7% of subjects in the faster aspart and insulin aspart groups, respectively. A nonsignificant trend toward better efficacy was observed with faster aspart (estimated treatment difference [ETD] [95% CI] in HbA1c change: -0.14% [-0.40, 0.11]). No new safety issues were found in either treatment group.

conclusionsOver 6 weeks of treatment, no microscopically confirmed infusion-set occlusions were observed for faster aspart or insulin aspart, indicating similar compatibility with CSII use.

Indexed as

AdultBlood GlucoseDiabetes Mellitus, Type 1Double-Blind MethodFemaleHumansHypoglycemiaHypoglycemic AgentsInsulin AspartInsulin Infusion SystemsMaleMiddle AgedTreatment OutcomeBlood GlucoseHypoglycemic AgentsInsulin Aspartinfusion set occlusioninsulin pumprapid-acting insulinsafetytype 1 diabetes mellitus

Identifiers

PMID28918652
PMCPMC5761985
OpenAlexW2754732254

What OpenQuestion holds

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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.