Join Trial Testing Ways To Improve Hypoglycemia Unawareness
A clinical trial is recruiting adults with type 1 diabetes who have impaired hypoglycemia awareness to see if automated insulin delivery systems and educational programs can help restore awareness.
Trial status: Recruiting
Clinical Trials Identifier: NCT06325202
Trial Name: Closed Loop and Education for Hypoglycemia Awareness Restoration (CLEAR)
Diabetes Type: Type 1 diabetes
Trial Sponsor: Milton S. Hershey Medical Center
Why is this study important?
This study is testing whether participating in educational programs is more effective than upgrading diabetes technology for restoring hypoglycemia awareness in people with type 1 diabetes.
Around a fifth of people with type 1 diabetes have an impaired sense of when their blood sugar has gone low. People with hypoglycemia unawareness are much more likely to experience severe low blood sugar that requires medical intervention, and the risk of these emergencies can make managing diabetes more difficult.
The longer a person has had diabetes, the more likely they are to have impaired hypoglycemia awareness. Over time, your brain can adapt to repeated dips in blood sugar and tune out the signals coming from your body. Your body may then begin to send weaker signals.
Diabetes technology like continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems measure changes in blood sugar. Theoretically, people who have impaired hypoglycemia awareness could just let wearables tell them when they have gone low, but researchers and healthcare providers have noticed that episodes of severe hypoglycemia continue to affect people with impaired awareness even after they start using these devices.
In fact, some people may start to normalize lows as nothing more than dips on a graph that don’t affect the way they feel; this normalization can contribute to further impairment of hypoglycemia awareness.
Researchers in the U.K. have developed two educational programs to help people regain their internal sense of low blood sugar. My HypoCOMPaSS (MHC) involves a couple of short, instructor-led sessions that focus on sensing subtle signs that may indicate a low and reinforcing the need to take hypoglycemia seriously.
The Hypoglycemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycemia Persisting Despite Optimized Self-Care (HARPdoc) is a more intensive program that lasts six weeks and involves four seven-hour sessions. It’s designed to help people overcome thoughts and beliefs that might prevent them from making the necessary changes to prevent lows.
How does the trial work?
Researchers are aiming to recruit 324 adults with type 1 diabetes. The trial is open to people who take multiple daily injections (MDI) and those who use AID systems.
Starting the trial, participants will complete what’s called a hypoglycemia clamp, a roughly four-hour procedure, which involves controlled infusions of insulin and glucose, allowing researchers to track a person’s hormonal response to low blood sugar. During that procedure, participants will also complete a questionnaire designed to assess their hypoglycemia awareness.
Each participant will then be randomly assigned to one of two treatment options. One group will continue using their current insulin delivery method and complete the MHC course, and the other won’t take the MHC course and instead will modify their insulin delivery method. For people who enter the trial using MDI, the latter option would mean switching to an AID system (Omnipod 5 or MiniMed 780G). For people who are already using an AID system, it would just mean optimizing the system’s settings.
After a year, all the participants will complete another clamp procedure and questionnaire. At that point, everyone whose hormonal responses to hypoglycemia have improved will continue their assigned insulin treatment method for another year. However, anyone whose hormonal response has not improved will be given a new random assignment: either they will make no changes and carry on with the insulin treatment method they were assigned, or they will stick to their assigned insulin delivery method and enroll in the six-week HARPdoc program.
After a second year, all of the participants will complete a third and final clamp procedure and questionnaire. The researchers will then check to see if HARPdoc helped people who had not improved after a year. Separately, they are also interested in knowing if people who saw improvements after one year continued to improve in the second year.
Are you interested in participating?
You may be eligible to participate if you are between the ages of 18 and 75 and:
- Were diagnosed with type 1 diabetes at least 10 years ago
- Have impaired hypoglycemia awareness as indicated by a Clarke or Gold score of four or higher
- Have an A1C value below 10.5%
- Have a random non-fasting C-peptide value below 0.2 pmol/mL
- Take less than one unit of insulin per kg per day
The study is currently recruiting at eight locations across the U.S., the U.K., and Australia. See a full list of inclusion and exclusion criteria here.
Learn more about hypoglycemia here: