NIH-funded research U01 cooperative agreement

Improving awareness of hypoglycemia in type 1 diabetes with targetted tech and education

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-11322615 · Data updated 2026-11-12

A study tests two treatments to help adults with type 1 diabetes who frequently misread signs of low blood sugar, using technology and education over 12 months with follow-up.

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)$77,134
NIH project number5U01DK135119-04
Project IDNIH-11322615 on NIH RePORTER

Who could benefit from this research

Could help

Adults with type 1 diabetes and impaired awareness of hypoglycemia, including those who are or are not using hybrid closed-loop systems.

Less likely to help

Individuals without impaired awareness or those who cannot participate in follow-up or the interventions may derive little to no benefit.

What this research studies

People with type 1 diabetes who don’t recognize hypoglycemia well will be enrolled in two parallel trials. One compares a hybrid closed-loop insulin system with a structured blood glucose awareness education program, while the other tests a different education-based approach against ongoing care for those whose awareness remains impaired. Each trial runs for 12 months with a preliminary run-in period and follows participants for up to two years to see how well the interventions restore normal body responses and practical awareness of low blood sugar. The study is multi-center and unblinded, with random assignment to treatment arms and staged crossover for some participants after 6 months. Outcomes include clinical awareness, safety, and physiological responses during controlled low-blood-sugar situations.

Why it matters

Potential benefit: If successful, participants and future patients could experience better recognition of hypoglycemia and fewer dangerous lows.

How similar studies have gone: Previous approaches have shown reductions in hypoglycemia and some restoration of awareness, but responses vary among 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.