Evaluating the effect of automated insulin pumps on pain levels in people with diabetes-related nerve damage
This study investigates if automated insulin pumps, known as hybrid closed-loop systems, can ease daily pain in people with type 1 diabetes who suffer from diabetes-related nerve damage. Many people with this condition find current pain medicines don't work well. These special pumps automatically adjust insulin and are thought to help stabilise blood sugar levels, which might reduce nerve pain. Participants will compare using their usual diabetes treatment with using the new pump for 12 weeks each. The study aims to find out if these advanced pumps can improve pain, sleep, and overall quality of life. It involves clinic visits, diaries, and using monitoring devices over about 32 weeks.
At a glance
What is this study about?
Many people living with type 1 diabetes can develop nerve damage, especially in their feet, which can become very painful. For some, this constant pain makes it hard to sleep and can affect their mood and general well-being. Existing pain medications don't always provide enough relief or can come with unwanted side effects.
Recent research suggests that not just high blood sugar, but also big ups and downs in blood sugar levels, might contribute to this nerve pain. This study is looking into a newer type of insulin pump, called a hybrid closed-loop system, which is sometimes called an 'artificial pancreas'. These pumps work with a sensor to automatically adjust insulin, helping to keep blood sugar levels more stable. The main aim of this study is to see if using these pumps can help lessen the daily pain experienced by people with diabetes-related nerve damage.
The study hopes to understand if these advanced insulin pumps can be a new way to manage nerve pain, potentially improving the lives of individuals struggling with this challenging complication. It will carefully compare the new pump system with standard care to see if there's a real difference in pain levels and overall well-being.
Key takeaways
- This study explores if an advanced insulin pump can reduce nerve pain in type 1 diabetes.
- It aims to make blood sugar levels more stable, which might ease pain.
- Participation involves comparing your usual care with using the new pump.
- You'll attend clinic visits, keep diaries, and use monitoring devices.
- The study lasts about 32 weeks in total for each participant.
- It offers early access to a new pump but requires a time commitment.
Who may be eligible?
To join this study, you need to have had type 1 diabetes for at least five years and be experiencing daily nerve pain related to your diabetes for at least three months. Your pain should be ongoing and register above a certain level on a pain scale.
There are also some requirements about your current diabetes control and how stable your pain medication has been. You'll need to be willing to follow the study schedule and give your written consent to participate. The study is open to both men and women, aged 18 or over.
You won't be able to take part if you have other types of nerve damage not caused by diabetes, more severe chronic pain conditions, certain serious mental health issues, or if you are pregnant, breastfeeding, or planning a pregnancy. Also, if you have severe sight or hearing problems that would make it difficult to use the study equipment, you might not be eligible.
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.
- Do I have type 1 diabetes and have I had it for over 5 years?
- Do I have daily nerve pain from my diabetes that has lasted at least 3 months?
- Is my daily pain level moderate or higher?
- Am I on stable medication for my nerve pain?
- Am I not pregnant, breastfeeding, or planning a pregnancy?
- Am I able to visit the study sites in Sheffield or Leicester?
What does participation involve?
If you decide to take part, the study will last about 32 weeks. It starts with an initial visit where doctors will ask about your health history and do a medical check-up. After this, you'll record your pain and sleep in diaries for four weeks.
Then, you'll go through two separate 12-week periods. In one period, you'll continue with your usual diabetes treatment. In the other, you'll use a hybrid closed-loop insulin pump (called the Tandem T:SlimX2) for 12 weeks. The order in which you do these two treatments will be decided randomly, like flipping a coin. Throughout the study, you'll also wear a blood sugar sensor and devices to track your activity and sleep.
At the end of each 12-week treatment period, you'll have another clinic visit for follow-up tests and to again complete your pain and sleep diaries.
Potential risks and benefits
Locations (4)
- Sheffield Teaching Hospitals NHS Foundation TrustCity onlySheffield, England
- University Hospitals of Leicester NHS TrustCity onlyLeicester, England
- Royal Hallamshire HospitalApproximateSheffield, England
- Leicester General HospitalApproximateLeicester, England
Common questions
What is a 'hybrid closed-loop insulin pump'?
It's an advanced insulin pump system, sometimes called an 'artificial pancreas', that automatically adjusts your insulin based on real-time blood sugar readings from a sensor.
What is 'diabetic peripheral neuropathy'?
It's nerve damage caused by diabetes, usually starting in the feet, which can cause pain.
How long will I be in the study?
Each person will be in the study for about 32 weeks, which includes different testing and treatment periods.
Will I have to pay to participate?
No, you won't have to pay to take part. The study equipment will be provided.
Who is funding this research?
The study is funded by TANDEM diabetes, the company that makes the specific hybrid closed-loop pumps being used.
How to find out more
Dinesh Selvarajah
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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