Trial reportJournal of diabetes science and technology2017
Randomized Cross-Over Study Comparing Two Infusion Sets for CSII in Daily Life.
Trial report in Journal of diabetes science and technology, 2017. 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.
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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.
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
- Advances in Insulin Infusion Set in the New Era of Automated Insulin Delivery: A Systematic Review.Journal of diabetes science and technology · 2023Pooled it
- A Multicenter Randomized Trial Evaluating Fast-Acting Insulin Aspart in the Bionic Pancreas in Adults with Type 1 Diabetes.Diabetes technology & therapeutics · 2022Trial
- Positive Impact of the Bionic Pancreas on Diabetes Control in Youth 6-17 Years Old with Type 1 Diabetes: A Multicenter Randomized Trial.Diabetes technology & therapeutics · 2022Trial
- Real-Time Detection of Infusion Site Failures in a Closed-Loop Artificial Pancreas.Journal of diabetes science and technology · 2018Trial
- Clinical utility of the twiist Automated Insulin Delivery System: first study with twiist.BMJ open diabetes research & care · 2026Article
- Dynamic actuation enhances transport and extends therapeutic lifespan in an implantable drug delivery platform.Nature communications · 2022Article
- Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial.Diabetes technology & therapeutics · 2022Article
- Concept and Implementation of a Novel Patch Pump for Insulin Delivery.Journal of diabetes science and technology · 2020Article
- First User Experiences With a Novel Touchscreen-Based Insulin Pump System in Daily Life of Patients With Type 1 Diabetes Experienced in Insulin Pump Therapy.Journal of diabetes science and technology · 2019Article
- Analysis of "Randomized Cross-Over Study Comparing Two Infusion Sets for CSII in Daily Life".Journal of diabetes science and technology · 2017Article
Corrections and comments
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Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundContinuous subcutaneous insulin infusion (CSII) therapy is a valuable option especially for people with type 1 diabetes. Although insulin infusion sets (IIS) are essential components of most insulin pump systems, only few studies have been conducted on their performance and safety. In this study 2 IIS with soft cannulas were compared.
methodsIn an open-label, randomized, crossover, multicenter 8-week study 80 type 1 diabetic subjects on CSII (20-74 years, mean 46.5 ± 12.9 years, 58.8% male) were enrolled to evaluate the use of 2 IIS. The Accu-Chek® FlexLink Plus (FL Plus) and the Accu-Chek® FlexLink infusion set (FL) were used 4 weeks each under real-life conditions at home. All patients had to record details about every IIS change in a diary. Insertion-related pain was assessed by means of a visual analogue scale (VAS).
resultsThe mean pain noted during insertion was similar for both IIS (VAS 6.1 ± 6.4 mm for the FL Plus and 5.8 ± 6.3 mm for the FL, P = .92). 20.0% of the 895 IIS changes with FL Plus and 16.0% of the 854 with FL were unplanned. During the 4243 patient days of the study, 13 patients had adverse events. Among these, 2 serious adverse events occurred. Both serious events and 1 nonserious adverse event were considered as related to the IIS. Of the patients, 18.7% had kinked cannulas. Most patients were satisfied with both IIS.
conclusionBoth IIS are safe and effective. The 2 IIS did not differ from each other with respect to pain observed during insertion.
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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.