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

Peter Lommer

Status: Completed

Conditions: Diabetes

Treatments: Device: ROTO track®

Study type: Interventional

Funder types: Other

Identifiers

NCT03407677

ROTOone

Details and patient eligibility

About

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.

Full 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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

ROTO Track

Other group

Description:

The individual patient will serve as his/her own control before intervention with ROTO Track

Treatment:

Device: ROTO track®