Participate in the CLEAR Research Study

The study will recruit and follow people who have been diagnosed with T1D for more than 10 years and with impaired awareness of hypoglycemia (IAH) at the time of screening. Using hybrid closed loop insulin pump systems or a mind/health intervention, we hope to reduce hypoglycemia and restore awareness of hypoglycemia for participants. Most potential participants will be identified based on a prior diagnosis of diabetes detected through reviews of medical histories, self-report, aided by electronic medical records and other databases.

A blood glucose of 70 mg/dL or below is considered hypoglycemia or “low” blood glucose. The American Diabetes Association recommends that people with Type 1 diabetes or those on insulin should regularly monitor their blood glucose levels. Throughout the day, these levels naturally fluctuate due to various factors. If the changes stay within your target range, you might not notice them. However, if your blood glucose drops below your target range, typically under 70 mg/dL, it can become dangerous and require immediate action to raise it back to a safe level.

A common condition among those with Type 1 diabetes is the inability to recognize when their glucose levels are low. This condition, called impaired awareness of hypoglycemia (IAH), can be dangerous because those patients cannot tell that they need to take action to bring glucose levels up. This phenomenon is more common among those who experience low blood glucose levels frequently, or those who have been living with Type 1 diabetes for ten years or more. Fortunately, existing and emerging diabetes technologies, combined with patient education, have the potential to restore symptom awareness in these patients and are currently being studied.

Our caring physicians screen every new patient accepted into a research study to ensure they meet the criteria to safely participate. Your participation is voluntary, and our research team continues to monitor your health and well-being during the length of the study.

There is no guarantee that participants will benefit from this research. It is hoped that the technological and psycho-educational interventions in this study will reduce hypoglycemia and improve awareness of hypoglycemia in participants with T1D. It is therefore possible that some participants may directly benefit from their involvement in this study.

These benefits could include:

• Chance of improving hypoglycemia awareness and subsequently reducing serious complications due to hypoglycemia
  
• Potential to access advanced diabetes technology
  
• Possible access to cutting-edge educational interventions designed for people who have problematic hypoglycemia
  
• Intensive education and support
  
• Close follow-up and more intensive diabetes monitoring
  
• Contribute to obtaining meaningful results for the care of people with T1D and IAH. The results of this study will advance the field by answering fundamental questions and improving clinical pathways for the care of people with T1D and IAH
  
• Potentially contribute to improving quality of life among people with diabetes (and their families) and reduce healthcare costs
  
• Compensation for participation, time and other study-related expenses