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OpenTrials
Completed

NCT Number: NCT03407677

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Research, Nordsjællands Hospital

Hillerød, 3400, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. rotation of insulin injections

    Time frame: 6 days

    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).

Secondary outcomes

  1. rotation of insulin injections

    Time frame: 12 weeks

    Number of insulin injections taken in a given subcutaneous skin area captured in a rotation score by the ROTO Track

  2. number of insulin infiltrates

    Time frame: 12 weeks

    documented by drawings and photos hereof

  3. glucose variability

    Time frame: 12 weeks

    measured by continuous glucose monitors

  4. glycaemic control

    Time frame: 12 weeks

    HbA1c

  5. Insulin dose requirement

    Time frame: 12 weeks

    captured i diaries

  6. Hypoglycaemic events

    Time frame: 12 weeks

    captured in diaries and by continuous glucose monitoring

  7. Patient reported outcomes

    Time frame: 12 weeks

    quality of life

  8. Patient reported outcomes

    Time frame: 12 weeks

    usability of the ROTO track®

  9. Accuracy of the ROTO track® injection log

    Time frame: 12 weeks

    assessed by comparison of diaries and data from the ROTO Track

Other outcomes

  1. Additional effect of an app in combination with the ROTO Track

    Time frame: Additional 12 weeks

    Number of insulin injections taken in a given subcutaneous skin area - captured in the rotation score

  2. Insulin infiltrates - numbers

    Time frame: additional 12 weeks

    drawings documented by photography

  3. Insulin dose requirement

    Time frame: additional 12 weeks

    from diaries

  4. glycaemic control

    Time frame: additional 12 weeks

    measured by HbA1c

Sponsors and collaborators

Lead sponsor

Peter Lommer

Other

Registry information

Official study title

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

Acronym: ROTOone

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2018
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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