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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: ROTO track®

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

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Department of Clinical Research, Nordsjællands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ROTO Track; The individual patient will serve as his/her own control before intervention with ROTO Track	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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Insulin infiltrates - numbers	drawings documented by photography	additional 12 weeks
Insulin dose requirement	from diaries	additional 12 weeks
glycaemic control	measured by HbA1c	additional 12 weeks

Collaborators and Investigators

• Sponsor: Peter Lommer
• Investigators: Principal Investigator: Peter L Kristensen, MD, PhD, Department of Clinical Research, Nordsjællands Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2018
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 27, 2019

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: ROTOone

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No