Diabetes
Conditions
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
Interventions
DEVICEROTO 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.
Sponsors
Peter Lommer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rotation of insulin injections | 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
| Measure | Time frame | Description |
|---|---|---|
| rotation of insulin injections | 12 weeks | Number of insulin injections taken in a given subcutaneous skin area captured in a rotation score by the ROTO Track |
| glucose variability | 12 weeks | measured by continuous glucose monitors |
| glycaemic control | 12 weeks | HbA1c |
| Insulin dose requirement | 12 weeks | captured i diaries |
| Accuracy of the ROTO track® injection log | 12 weeks | assessed by comparison of diaries and data from the ROTO Track |
| Hypoglycaemic events | 12 weeks | captured in diaries and by continuous glucose monitoring |
| Patient reported outcomes | 12 weeks | quality of life |
| number of insulin infiltrates | 12 weeks | documented by drawings and photos hereof |
Other
| Measure | Time frame | Description |
|---|---|---|
| Insulin dose requirement | additional 12 weeks | from diaries |
| glycaemic control | additional 12 weeks | measured by HbA1c |
| Additional effect of an app in combination with the ROTO Track | Additional 12 weeks | Number of insulin injections taken in a given subcutaneous skin area - captured in the rotation score |
| Insulin infiltrates - numbers | additional 12 weeks | drawings documented by photography |
Countries
Denmark
Outcome results
None listed