Clinical trial NCT03407677: The Impact of ROTO Track® in Helping Patients With Diabetes Rotate Their Insulin Injections Better
Official title: The Impact of ROTO Track® in Helping Patients With Diabetes Rotate Their Insulin Injections Better - a Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: rotation of insulin injections
timeFrame: 6 days
Secondary outcomes:
measure: rotation of insulin injections
timeFrame: 12 weeks
measure: number of insulin infiltrates
timeFrame: 12 weeks
measure: glucose variability
timeFrame: 12 weeks
measure: glycaemic control
timeFrame: 12 weeks
measure: Insulin dose requirement
timeFrame: 12 weeks
measure: Hypoglycaemic events
timeFrame: 12 weeks
measure: Patient reported outcomes
timeFrame: 12 weeks
measure: Patient reported outcomes
timeFrame: 12 weeks
measure: Accuracy of the ROTO track® injection log
timeFrame: 12 weeks
Other outcomes:
measure: Additional effect of an app in combination with the ROTO Track
timeFrame: Additional 12 weeks
measure: Insulin infiltrates - numbers
timeFrame: additional 12 weeks
measure: Insulin dose requirement
timeFrame: additional 12 weeks
measure: glycaemic control
timeFrame: additional 12 weeks
Locations:
city: Hillerød
country: Denmark
facility: Department of Clinical Research, Nordsjællands Hospital
Study officials:
affiliation: Department of Clinical Research, Nordsjællands Hospital
name: Peter L Kristensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: