Trial reportDrug delivery and translational research2015
Intradermal insulin infusion achieves faster insulin action than subcutaneous infusion for 3-day wear.
Trial report in Drug delivery and translational research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
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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.
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
17 citing papers in PubMed, 39 citations in OpenAlex.
- Comprehensive evaluation of microneedle-based intradermal adalimumab delivery vs. subcutaneous administration: results of a randomized controlled clinical trial.British journal of clinical pharmacology · 2021Trial
- Improved Insulin Pharmacokinetics Using a Novel Microneedle Device for Intradermal Delivery in Patients with Type 2 Diabetes.Diabetes technology & therapeutics · 2016Trial
- Microneedles as a Promising Technology for Disease Monitoring and Drug Delivery: A Review.ACS materials Au · 2025Review
- Effectiveness, safety, and preference of transdermal insulin compared to subcutaneous insulin in the treatment of diabetes patients: a systematic review of clinical trials.Diabetology & metabolic syndrome · 2024Review
- Repeated insulin injection without site rotation affects skin thickness - ultrasonographic and histological evaluation.Journal of diabetes investigation · 2022Article
- A Microtube-Based Wearable Closed-Loop Minisystem for Diabetes Management.Research (Washington, D.C.) · 2022Article
- Challenges and opportunities for small volumes delivery into the skin.Biomicrofluidics · 2021Article
- The Current Status of Clinical Research Involving Microneedles: A Systematic Review.Pharmaceutics · 2020Review
- A basal-bolus insulin regimen integrated microneedle patch for intraday postprandial glucose control.Science advances · 2020Article
- Sugar-Lowering Drugs for Type 2 Diabetes Mellitus and Metabolic Syndrome-Strategies for In Vivo Administration: Part-II.Journal of clinical medicine · 2019Review
- Evaluating the Impact of Human Factors and Pen Needle Design on Insulin Pen Injection.Journal of diabetes science and technology · 2019Article
- Subcutaneous Insulin Administration: Sufficient Progress or Ongoing Need?Journal of diabetes science and technology · 2019Article
- Factors Affecting the Absorption of Subcutaneously Administered Insulin: Effect on Variability.Journal of diabetes research · 2018Review
- Challenges and Future Prospects for the Delivery of Biologics: Oral Mucosal, Pulmonary, and Transdermal Routes.The AAPS journal · 2017Article
- Insulin (Technique) Induced Hypoglycaemia.Journal of clinical and diagnostic research : JCDR · 2017Article
- Light Control of Insulin Release and Blood Glucose Using an Injectable Photoactivated Depot.Molecular pharmaceutics · 2016Article
- Towards a Physiological Prandial Insulin Profile: Enhancement of Subcutaneously Injected Prandial Insulin Using Local Warming Devices.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Rapid uptake previously demonstrated by intradermal (ID) drug administration indicates compound delivery within the dermis may have clinical and pharmacological advantages for certain drug therapies. This study is the first clinical trial to evaluate continuous microneedle-based drug infusion, device wearability, and intradermal microneedle insulin kinetics over a multi-day (72 h) wear period. This was a single center, open-label, two-period crossover study in T1DM patients on continuous subcutaneous insulin infusion (CSII). Patients received treatment during interventional visits: one SC and one ID basal/bolus infusion of insulin aspart (NovoRapid® U-100) administered over 3 days in a randomized order. Twenty-eight patients were randomized and exposed to trial product, and 23 completed the study. Bolus insulin infusions were given prior to standardized breakfast and lunch test meals on each of the three treatment days. Blood samples were drawn at predefined time points for measurements of insulin aspart and blood glucose in serum. The primary endpoint insulin Tmax demonstrated that ID bolus infusion was associated with a significantly shorter Tmax with statistically significantly smaller intra-subject variability, compared to SC infusion, and this difference was maintained over three treatment days. Analyses of secondary PK endpoints corresponded with the primary endpoint findings. Postprandial glycemic response was significantly less pronounced after ID bolus: For most endpoints ID vs. SC, differences were statistically significant within the 0-1.5 or 0-2 h time period. Intradermal delivery of insulin is a viable delivery route alternative providing reduced time for insulin absorption with less intra-subject variability and lower glycemic response.
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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.