NIH-funded research U01 cooperative agreement

Techniques for restoring awareness of low blood sugar in adults with type 1 diabetes

Official title: Utilizing an RCT Approach to Compare the Efficacy and Sustainability of Technological and Psycho-Educational Interventions to Improve Impaired Awareness of Hypoglycemia in Type 1 Diabetes.

Funded at University of Sheffield · NIH-11603069 · Data updated 2026-11-12

A randomized trial compares different approaches to help adults with type 1 diabetes recognize when their blood sugar is dipping so they can act quickly.

More Diabetes research and trials

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionUniversity of Sheffield
NIH-funded
Lab location1 site (Sheffield, United Kingdom)
Project startSeptember 25, 2022
Project endDecember 31, 2027
Funding year2026
Award (this year)$39,622
NIH project number3U01DK135119-04S3
Project IDNIH-11603069 on NIH RePORTER

Who could benefit from this research

Could help

Adults with type 1 diabetes who have impaired awareness of hypoglycemia, including some with resolved or persistent symptoms after prior treatments.

Less likely to help

People without impaired awareness or those not willing to participate in long-term follow-up may not benefit.

What this research studies

This study tests two big questions: which treatment works best to restore awareness of hypoglycemia in people with type 1 diabetes, and how durable that benefit is over two years. It runs two parallel, multi-center trials over 12 months, with a short run-in and extended follow-up up to 24 months. Participants receive either hybrid closed-loop insulin delivery or a structured education program, with crossover options for some groups. The researchers will measure physiological responses and real-world awareness to determine which approach helps patients stay safer.

Why it matters

Potential benefit: If successful, the findings could help more adults with type 1 diabetes prevent severe hypoglycemia by recognizing warning signs sooner and acting promptly.

How similar studies have gone: Previous approaches like hybrid closed-loop and education have shown benefits, but responses vary across individuals.

Where this research is happening

  • University of Sheffield
    Sheffield, United Kingdom
    Active

Researchers

  • Principal investigator: Heller, Simon Richard — University of Sheffield
  • Study coordinator: Heller, Simon Richard

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.