NIH-funded research U01 cooperative agreement

Improved insulin systems for adults with type 1 diabetes who don’t notice low blood sugar

Official title: Advanced Insulin Delivery to Reduce Impaired Awareness of Hypoglycemia in a T1D Cohort (AIDRIAHT1C)

Funded at Adventhealth Orlando · NIH-11319846 · Data updated 2026-11-12

Adults with long-standing type 1 diabetes who often miss low blood sugar will use either an automated hybrid closed-loop insulin system or a sensor-linked insulin pump to see which helps them notice and avoid hypoglycemia.

More Hypoglycemia research and trials

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionAdventhealth Orlando
NIH-funded
Lab location1 site (Orlando, United States)
Project startSeptember 25, 2022
Project endDecember 31, 2027
Funding year2026
Award (this year)$740,881
NIH project number5U01DK135131-04
Project IDNIH-11319846 on NIH RePORTER

Who could benefit from this research

Could help

Adults (21+) with type 1 diabetes of at least ten years’ duration who score positive for impaired awareness of hypoglycemia on the HYPO score are ideal candidates.

Less likely to help

People without impaired hypoglycemia awareness, with very recent-onset type 1 diabetes, or unwilling/unable to use pumps and continuous glucose monitors are unlikely to benefit from joining.

What this research studies

You would join if you are an adult with type 1 diabetes for at least ten years and have reduced awareness of low blood sugar as measured by the HYPO score. Participants who meet that definition are randomly assigned 1:1 to a hybrid closed-loop (HCL) insulin delivery system or to sensor-augmented pump (SAP) therapy. Both groups receive a targeted education program aimed at reducing hypoglycemia, and continuous glucose monitoring and pump data will be used to measure time spent in low glucose and changes in awareness. The study also looks at counter-regulatory responses and brain-related changes linked to impaired awareness.

Why it matters

Potential benefit: If successful, the approach could help people with impaired hypoglycemia awareness notice lows sooner and reduce dangerous severe hypoglycemic episodes.

How similar studies have gone: Hybrid closed-loop systems have already lowered time in hypoglycemia in prior trials, but using them specifically to restore hypoglycemia awareness and counter-regulatory responses is a newer application.

Where this research is happening

  • Adventhealth Orlando
    Orlando, United States
    Active

Researchers

  • Principal investigator: Pratley, Richard E — Adventhealth Orlando
  • Study coordinator: Pratley, Richard E

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.