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

NCT03407677 | Completed

• 1 other identifier: ROTOone
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• rotation of insulin injections

  12 weeks

• number of insulin infiltrates

  12 weeks

• glucose variability

  12 weeks

• glycaemic control

  12 weeks

• Insulin dose requirement

  12 weeks

Other Outcomes (4)

• Additional effect of an app in combination with the ROTO Track

  Additional 12 weeks

• Insulin infiltrates - numbers

  additional 12 weeks

• Insulin dose requirement

  additional 12 weeks

Study Arms (1)

ROTO Track

OTHER

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

Device: ROTO track®

Interventions

ROTO track® DEVICE

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.

ROTO Track

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Blind or severely impaired eyesight
• History of alcohol or drug abuse

Sponsors & Collaborators

• Peter Lommer: lead

Study Sites (1)

Department of Clinical Research, Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Peter L Kristensen, MD, PhD

  Department of Clinical Research, Nordsjællands Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: During the baseline period patients will be blinded to the feature of the ROTO track®, which registers site of insulin injection and the features (vibration and light) that can assist the patient in rotation of injections. Patients will in the first week of the study be informed, that the ROTO track® is being developed as a new automatic device to register data on insulin injections including day, time and dose of insulin.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department, Endocrinology and Nephrology Department

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 23, 2018
• Study Start: August 27, 2018
• Primary Completion: November 20, 2019
• Study Completion: November 27, 2019
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

DK (1)