Department of Clinical Research, Nordsjællands Hospital
Hillerød, 3400, Denmark
NCT Number: NCT03407677
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Hillerød, 3400, Denmark
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 days
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: 12 weeks
Number of insulin injections taken in a given subcutaneous skin area captured in a rotation score by the ROTO Track
Time frame: 12 weeks
documented by drawings and photos hereof
Time frame: 12 weeks
measured by continuous glucose monitors
Time frame: 12 weeks
HbA1c
Time frame: 12 weeks
captured i diaries
Time frame: 12 weeks
captured in diaries and by continuous glucose monitoring
Time frame: 12 weeks
quality of life
Time frame: 12 weeks
usability of the ROTO track®
Time frame: 12 weeks
assessed by comparison of diaries and data from the ROTO Track
Time frame: Additional 12 weeks
Number of insulin injections taken in a given subcutaneous skin area - captured in the rotation score
Time frame: additional 12 weeks
drawings documented by photography
Time frame: additional 12 weeks
from diaries
Time frame: additional 12 weeks
measured by HbA1c
Peter Lommer
Other
The Impact of ROTO Track® in Helping Patients With Diabetes Rotate Their Insulin Injections Better - a Proof-of-concept Study
Acronym: ROTOone
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00837122
Cardiovascular Diseases, Diabetes
Accra, Ghana
View Trial DetailsNCT03899883
Diabetes, Diabetes Complications
Aurora, Colorado, United States
View Trial DetailsNCT00065676
Body Weight, Diabetes
Bethesda, Maryland, United States
View Trial DetailsNCT00862433
Body Weight, Diabetes
Bethesda, Maryland, United States
View Trial Details