NCT03407677: ROTOone

The Impact of ROTO Track® in Helping Patients With Diabetes Rotate Their Insulin Injections Better

Completed NA Last updated 3 March 2021

What this trial tests

NA trial testing ROTO track® in Diabetes in 35 participants. Completed in 27 November 2019.

Timeline

27 August 2018

Primary endpoint
20 November 2019

27 November 2019

Quick facts

Lead sponsor	Peter Lommer
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	35
Start date	27 August 2018
Primary completion	20 November 2019
Estimated completion	27 November 2019
Sites	1 location across Denmark

Drugs / interventions tested

• ROTO track®

Conditions studied

• Diabetes — all drugs for Diabetes →

Sponsor

Peter Lommer

Who can join

18 and older, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The ROTO track® is an electronic injection form and injection log for keeping track of injection sites in the abdominal region. The device attaches directly to the insulin pen and activates whenever the insulin pen is picked up. Small LED lights on the device will indicate where the next injection site is according to the individual patient's injection plan. By moving the pen and device to an "anchor point" in front of the navel, the device is able to start tracking where the insulin pen is being moved to. The device additionally contains a haptic interface to indicate to the user when the device has been moved to the next area in the injection plan.

The device registers the location, the time and the dosage automatically when the patient injects insulin with the pen

The rationale of the trial is that the ROTO track® can help patients rotate their injections sites and that this will provide the healthcare system with a new cost-effective tool for improving insulin injection techniques.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 56^th EASD Annual Meeting of the European Association for the Study of Diabetes : 21-25 September 2020.
   · 2020 · cited 9× · PMID 32840677 · DOI 10.1007/s00125-020-05221-5
2. A New Medical Device for Improved Rotation of Insulin Injections in Type 1 Diabetes Mellitus: A Proof-of-Concept Study.
   Klarskov CK, Hamid YH, Tjalk-Bøggild R, Tarnow L, et al · · 2021 · cited 4× · PMID 32830524 · DOI 10.1177/1932296820950688