Evidence map›Paper›PMID 30381961›Full record

ArticleJournal of diabetes science and technology2019

Developing a Simple 3-Day Insulin Delivery Device to Meet the Needs of People With Type 2 Diabetes.

Leslie C Lilly, Julia K Mader, Jay Warner

Abstract read
In one paragraph

Article in Journal of diabetes science and technology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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

6 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Article
  5. Patch Pumps for Insulin.Journal of diabetes science and technology · 2019
    Review
  6. Insulin Pumping Patches: Emerging Insulin Delivery Systems.Journal of diabetes science and technology · 2019
    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

3 authors.

Leslie C Lilly1 Lilly Clinical Research Consulting, Concord, MA, USA.ORCID 0000-0002-3232-0645
Julia K Mader2 Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
Jay Warner3 CeQur Corporation, Marlborough, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimWe sought to design an insulin delivery method that would overcome barriers to insulin therapy and meet the needs of the users, adults with diabetes, and their health care providers (HCPs).

methodsWe conducted focus groups and human factors studies with users to learn about their needs and requirements. We then designed an insulin delivery device, PAQ, with features that met the user's requirements. Iterative design and human factors testing (HFT) was performed with adults with diabetes on ⩾2 injections/day and HCPs. In parallel, studies were conducted to identify an adhesive that stayed adhered for 3 days and caused minimal, if any, dermal irritation. Pilot clinical studies were then initiated.

resultsUsers want a way to administer insulin that is simple, discreet, safe, and effective. A summative HFT found the device was easy to learn and use. All participants (30/30, 100%) successfully completed the key performance measures tested. An adhesive validation study in 30 adults with diabetes found 90% of the devices remained adhered to the participant's application site at the end of 3 days with minimal skin irritation. Data from 3 clinical studies revealed 74-75% transitioned from injectable insulin to the device with the first fixed basal rate selected, improved glycemic control, and participants' satisfaction with the device.

conclusionThe collective data from the HFT, adhesive, and clinical studies demonstrated that the device provides a method of insulin delivery that overcomes barriers to injectable insulin, meets the needs of the user, and achieves glycemic control.

Indexed as

Insulin Infusion SystemsAdhesivesAdultAttitude of Health PersonnelBlood GlucoseDiabetes Mellitus, Type 2Drug Administration ScheduleEquipment DesignFemaleFocus GroupsHealth Services AccessibilityHumansHypoglycemic AgentsInjectionsInsulinMaleAdhesivesBlood GlucoseHypoglycemic AgentsInsulinadherencecontinuous subcutaneous insulin infusioninsulin deliveryinsulin pumpstype 2 diabetes

Identifiers

PMID30381961
PMCPMC6313288

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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.