NIH-funded research U01 cooperative agreement

Treating impaired hypoglycemia awareness in type 1 diabetes with targeted education and technology

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-11603068 · Data updated 2026-11-12

This study tests two treatment approaches to help adults with type 1 diabetes who often don’t realize their blood sugar is getting too low, using a mix of technology and education in two large groups.

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)$3,050
NIH project number3U01DK135119-04S2
Project IDNIH-11603068 on NIH RePORTER

Who could benefit from this research

Could help

Adults with type 1 diabetes and impaired awareness of hypoglycemia who meet trial criteria and are able to participate in a multi-center randomized study.

Less likely to help

People without impaired hypoglycemia awareness or those unable to participate in follow-up assessments may not benefit.

What this research studies

Researchers at multiple centers in the UK will run two parallel randomized trials over 12 months (plus longer follow-up) to see which approach best restores awareness of hypoglycemia in adults with type 1 diabetes. One trial compares a hybrid closed-loop insulin system with blood glucose awareness training, while the other compares two education/behavior programs for those whose awareness remains impaired despite prior tech use. Participants will be assigned to their treatment arms, then followed for up to 24 months to evaluate physiological and clinical responses to hypoglycemia. The study aims to identify which combination of strategies best reverses impaired awareness and reduces risk of severe lows.

Why it matters

Potential benefit: If successful, patients could regain better recognition of low blood sugar and reduce dangerous hypoglycemic events.

How similar studies have gone: Previous approaches with technology and education have shown benefits, but responses vary, making this a novel comparison of strategies.

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.