Looking at the effect of the smart multiple daily injections (MDI) system (inPen™) in type 2 diabetes
This study is investigating a new smart insulin system called inPen™ for adults in the UK with Type 2 diabetes. The InPen™ system includes a smart insulin pen and a continuous glucose monitoring (CGM) sensor, working together with an app to help track insulin doses, remind users, and suggest dose adjustments. Researchers want to find out if using this smart system is more effective for managing Type 2 diabetes compared to using a standard insulin pen alongside a CGM sensor. About 78 adults will be involved. Participants are randomly put into one of two groups. The study will last from November 2024 to June 2026 and is funded by Medtronic (UK).
At a glance
What is this study about?
This study is looking into a new way for people with Type 2 diabetes to manage their insulin. It's called the InPen™ Smart MDI system. This system involves a special 'smart' insulin pen that connects to a sensor worn on your body (a continuous glucose monitor, or CGM) and a mobile app. Together, they can help you keep track of your insulin doses, remind you when to take them, and even offer advice on how much insulin to use.
The main aim of this research is to see if using this InPen™ smart system is better at helping people with Type 2 diabetes manage their blood sugar levels compared to using a regular insulin pen alongside a CGM sensor. By helping people manage their blood sugar more effectively, the hope is to improve overall health and reduce the risk of diabetes-related problems.
The study will involve up to 78 adults across the UK. Researchers at the University of Leicester are running it, with funding from Medtronic (UK). It's an important study because it could help improve how people with Type 2 diabetes use insulin in the future.
Key takeaways
- This study evaluates a 'smart' insulin pen system for Type 2 diabetes.
- It compares the smart pen with standard insulin pens, both used with continuous glucose sensors.
- Around 78 UK adults will participate in this research.
- The study aims to see if the smart system helps manage blood sugar better.
- It runs from November 2024 to June 2026.
Who may be eligible?
This study is for adults aged 18 or over who have Type 2 diabetes. You would need to have been using insulin for more than two years, specifically taking at least two quick-acting insulin doses each day alongside your background insulin.
Your recent HbA1c blood test result (which shows your average blood sugar over the last few months) should be 8.0% or higher. You should also be on stable doses of certain other diabetes medications (GLP-1 and/or SGLT2i) for at least three months. You must be willing to use the study's glucose sensor and app, and be using specific brands of quick-acting insulin, or be willing to switch to one of them if needed.
There are also reasons why you might not be able to join. For example, if you have severe kidney problems, significant vision or hearing difficulties that would make using the devices hard, or skin issues where the sensor would be placed. You also can't be taking part in another drug or device study at the same time, or if your doctor feels that increasing your diabetes treatment isn't suitable for your overall health.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older with Type 2 diabetes?
- Have you been using insulin for over two years, including quick-acting insulin at least twice a day?
- Is your recent HbA1c level 8.0% or higher?
- Are you willing to use a study glucose sensor and connect data via a cloud system?
- Are you currently using or willing to use specific brands of quick-acting insulin (Humalog, Novolog, Novorapid, Lyumjev, or Fiasp)?
What does participation involve?
If you join this study, you'll be put into one of two groups by chance. One group will use the InPen™ Smart MDI system, while the other will use their standard insulin pen alongside a CGM sensor. This process is 'random,' meaning you won't choose which group you are in.
The study will record information about your insulin use and blood sugar levels. You'll need to use the study's CGM sensor, and your data will be connected through a cloud system. The study aims to look at your blood sugar control over time. The study is expected to run from November 2024 to June 2026, and your involvement will last for a specific period within that timeframe, which will be explained in detail.
Potential risks and benefits
Locations (1)
- Leicester Diabetes CentreApproximateLeicester, United Kingdom
Common questions
What is Type 2 diabetes?
Type 2 diabetes is a common condition where the body doesn't produce enough insulin or the insulin it does produce doesn't work properly, leading to high blood sugar levels.
What is a 'smart' insulin pen?
A smart insulin pen helps you manage your insulin by tracking doses, reminding you to take them, and connecting with an app to give dose suggestions based on your blood sugar.
What is an HbA1c test?
An HbA1c test is a blood test that shows your average blood sugar levels over the past two to three months. It's a key measure for diabetes management.
Will I have to pay to be in the study?
No, you will not have to pay to participate in this study. All study-related devices and monitoring will be provided.
Who is funding this research?
This study is funded by Medtronic (UK), a company that makes medical devices.
How to find out more
Pratik Choudhary
Always speak to your GP or specialist before deciding to take part in a study.
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