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

Diabetes Clinical Trial

— ROTOone  

Official title:

The Impact of ROTO Track® in Helping Patients With Diabetes Rotate Their Insulin Injections Better - a Proof-of-concept Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407677
• Other study ID #: ROTOone
• Status: Completed
• Phase: N/A
• Start date: August 27, 2018
• Est. completion date: November 27, 2019

Study information

• Verified date: March 2021
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 27, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent obtained before any trial related procedures are performed

2. Male or female aged 18 years

3. Type 1 diabetes with a duration of two or more years

4. Treated with three or more daily pen injections of Novo Rapid™ in the abdominal region

5. The subject must be willing and able to comply with trial protocol

Exclusion Criteria:

1. Blind or severely impaired eyesight

2. History of alcohol or drug abuse

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Clinical Research, Nordsjællands Hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Peter Lommer

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Additional 12 weeks
Other	Insulin infiltrates - numbers	drawings documented by photography	additional 12 weeks
Other	Insulin dose requirement	from diaries	additional 12 weeks
Other	glycaemic control	measured by HbA1c	additional 12 weeks
Primary	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).	6 days
Secondary	rotation of insulin injections	Number of insulin injections taken in a given subcutaneous skin area captured in a rotation score by the ROTO Track	12 weeks
Secondary	number of insulin infiltrates	documented by drawings and photos hereof	12 weeks
Secondary	glucose variability	measured by continuous glucose monitors	12 weeks
Secondary	glycaemic control	HbA1c	12 weeks
Secondary	Insulin dose requirement	captured i diaries	12 weeks
Secondary	Hypoglycaemic events	captured in diaries and by continuous glucose monitoring	12 weeks
Secondary	Patient reported outcomes	quality of life	12 weeks
Secondary	Patient reported outcomes	usability of the ROTO track®	12 weeks
Secondary	Accuracy of the ROTO track® injection log	assessed by comparison of diaries and data from the ROTO Track	12 weeks