NIH-funded research U01 cooperative agreement

Technological and Educational Approaches to Restore Hypoglycemia Awareness in 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-11603070 · Data updated 2026-11-12

A two-arm study in adults with type 1 diabetes tests whether high-tech glucose control plus education or targeted training can help people regain awareness of low blood sugar.

More Type 1 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)$43,645
NIH project number3U01DK135119-04S4
Project IDNIH-11603070 on NIH RePORTER

Who could benefit from this research

Could help

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

Less likely to help

People without impaired awareness of hypoglycemia or those unable to participate in a multi-center trial may not benefit.

What this research studies

This trial runs in multiple centers over 12 months with follow-up to 24 months to compare two strategies for improving hypoglycemia awareness in adults with type 1 diabetes. One arm uses hybrid closed-loop insulin delivery, the other uses blood glucose awareness training, with a run-in period to establish baselines. Participants who do not initially respond may cross over to alternate strategies, helping us understand which approach works best for different patients. The study looks at physiological responses to controlled hypoglycemia and clinical awareness outcomes to guide future treatment choices.

Why it matters

Potential benefit: If successful, patients could regain better recognition of low blood sugar and reduce severe hypoglycemia.

How similar studies have gone: Previous work suggests benefit from both hybrid closed-loop systems and educational programs, 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.