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

Study Overview
=================
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

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

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: ROTO track®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained before any trial related procedures are performed Male or female aged 18 years Type 1 diabetes with a duration of two or more years Treated with three or more daily pen injections of Novo Rapid™ in the abdominal region The subject must be willing and able to comply with trial protocol Exclusion Criteria: Blind or severely impaired eyesight History of alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ROTO Track<br>The individual patient will serve as his/her own control before intervention with ROTO Track | Device: ROTO track®<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| number of insulin infiltrates | documented by drawings and photos hereof | 12 weeks | 
| glucose variability | measured by continuous glucose monitors | 12 weeks | 
| glycaemic control | HbA1c | 12 weeks | 
| Insulin dose requirement | captured i diaries | 12 weeks | 
| Hypoglycaemic events | captured in diaries and by continuous glucose monitoring | 12 weeks | 
| Patient reported outcomes | quality of life | 12 weeks | 
| Patient reported outcomes | usability of the ROTO track® | 12 weeks | 
| Accuracy of the ROTO track® injection log | assessed by comparison of diaries and data from the ROTO Track | 12 weeks |