An interventional study of ROTO track® in Diabetes, sponsored by Peter Lommer. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-03.
Sponsored by Peter Lommer · Not applicable, Interventional, and Supportive care
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.
Both observational and interventional studies have reported that proper rotation of injection sites can be obtained through intensive injection technique training, education and follow up of patients. Furthermore, this has significant beneficial effects on daily glycaemic variations, hypoglycaemic events, long term blood glucose levels, and insulin dose requirements. This is however frequently not done appropriately in every day practice.
At a small workshop at Nordsjællands Hospital in November 2017 with patients with type 1 diabetes the value of a device to registrar time, dose and rotation of insulin injections were discussed. All patients considered their own injection patterns as satisfying - although only one in four used a systematic approach. Most patients relied on their healthcare provider to identify side effects like lipohypertrophy, half of the patients re-used needles more than once and two took injections through the clothes now and then. All subjects would prefer a simple and small device to be used with the pen for the lifetime of the pen to minimize time used for injections and attraction of attention from other people.
The hypothesis is that the ROTO track® can reduce the number of insulin injections in the same subcutaneous skin area as compared with standard insulin injection instructions in patients with type 1 diabetes. The reduction of injection in same skin area will be quantified by a rotation score
Exclusion Criteria:
The individual patient will serve as his/her own control before intervention with ROTO Track
Device: ROTO track®
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.
rotation of insulin injections
Number of insulin injections taken in a given subcutaneous skin area will be captured in a rotation score by the ROTO track® . The rotation score is a single ratio value that combines the distribution over the skin areas used with the time between re-use of a field. The value is set from 0 (meaning every injections in a single area) to 1 (meaning perfect rotation with the maximum possible time between two injections in the same skin area).
Time frame: 6 days
rotation of insulin injections
Number of insulin injections taken in a given subcutaneous skin area captured in a rotation score by the ROTO Track
Time frame: 12 weeks
number of insulin infiltrates
documented by drawings and photos hereof
Time frame: 12 weeks
glucose variability
measured by continuous glucose monitors
Time frame: 12 weeks
glycaemic control
HbA1c
Time frame: 12 weeks
Insulin dose requirement
captured i diaries
Time frame: 12 weeks
Hypoglycaemic events
captured in diaries and by continuous glucose monitoring
Time frame: 12 weeks
Patient reported outcomes
quality of life
Time frame: 12 weeks
Patient reported outcomes
usability of the ROTO track®
Time frame: 12 weeks
Accuracy of the ROTO track® injection log
assessed by comparison of diaries and data from the ROTO Track
Time frame: 12 weeks
Additional effect of an app in combination with the ROTO Track
Number of insulin injections taken in a given subcutaneous skin area - captured in the rotation score
Time frame: Additional 12 weeks
Insulin infiltrates - numbers
drawings documented by photography
Time frame: additional 12 weeks
Insulin dose requirement
from diaries
Time frame: additional 12 weeks
glycaemic control
measured by HbA1c
Time frame: additional 12 weeks
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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