Closed Loop and Education for Hypoglycemia Awareness Restoration

Part of paid clinical trials in La Jolla, California.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT06325202
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Omnipod 5 or Medtronic 780G — DEVICE
    Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
  • My HypoCOMPaSS Education — BEHAVIORAL
    My HypoCOMPaSS is a brief, standardized psycho-educational program delivered in small groups. Facilitated discussions focus on advocating rigorous avoidance of hypoglycemia while maintaining time in target glycemic range.
  • HARPdoc Education — BEHAVIORAL
    The HARPdoc program targets cognitions around hypoglycemia that act as barriers to hypoglycemia avoidance and recovery of awareness using motivational and cognitive approaches, delivered by diabetes educators, trained and supported by a clinical psychologist, in small group format.

Study Details

The purpose of the CLEAR study is to determine the effect on counterregulatory responses (CRR) of intervening (by attempting to strictly avoid hypoglycemia) to improve awareness of hypoglycemic symptoms among adults with type 1 diabetes (T1D) who have impaired awareness of hypoglycemia (IAH). IAH affects 20-25% of adults with T1D, and rises with increasing duration of T1D.

Key Dates

Start date
Oct 3, 2025
Status verified
Feb 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
324 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: current HCL non-user: HCL x 24 months
    Hybrid closed loop device over a 24-month period for individuals currently not using a hybrid closed loop device
  • Experimental: current HCL non-user: HCL x 12 months, then HCL x an additional 12 months
    Hybrid closed loop device over a 12-month period for individuals currently not using a hybrid closed loop device, and then a hybrid closed loop device for an additional 12 months
  • Experimental: current HCL non-user: HCL x 12 months, then HCL + HARPdoc x 12 months
    Hybrid closed loop device over a 12-month period for individuals currently not using a hybrid closed loop device, then a hybrid closed loop device plus HARPdoc education for an additional 12 months
  • Active Comparator: current HCL non-user: Usual Care and My HypoCOMPaSS x 12 months, then HCL x 12 months
    Usual Care and My HypoCOMPaSS education over 12 months for individuals currently not using a hybrid closed loop device, then hybrid closed loop device for 12 months
  • Active Comparator: current HCL non-user: Usual Care and My HypoCOMPaSS x 24 months
    Usual Care and My HypoCOMPaSS education over 24 months for individuals currently not using a hybrid closed loop device
  • Experimental: current HCL user: HCL x 24 months
    Hybrid closed loop device over a 24-month period for individuals currently using a hybrid closed loop device
  • Experimental: current HCL user: HCL x 12 months, then HCL x an additional 12 months
    Hybrid closed loop device over a 12-month period for individuals currently using a hybrid closed loop device, and then a hybrid closed loop device for an additional 12 months
  • Experimental: current HCL user: HCL x 12 months, then HCL + HARPdoc x 12 months
    Hybrid closed loop device over a 12-month period for individuals currently using a hybrid closed loop device, then a hybrid closed loop device plus HARPdoc education for an additional 12 months
  • Active Comparator: current HCL user: HCL and My HypoCOMPaSS x 12 months, then HCL x 12 months
    Hybrid closed loop device and My HypoCOMPaSS education over 12 months for individuals currently using a hybrid closed loop device, then hybrid closed loop device for 12 months
  • Active Comparator: current HCL user: HCL + My HypoCOMPaSS x 12 months, then HCL + My HypoCOMPaSS + HARPDOC x 12 months
    Hybrid closed loop device and My HypoCOMPaSS education over 12 months for individuals currently using a hybrid closed loop device, then hybrid closed loop device plus My HypoCOMPaSS eduction + HARPdoc education for 12 months
  • Experimental: current HCL user: HCL + My HypoCOMPaSS x 24 months
    Hybrid closed loop device plus My HypoCOMPaSS education over a 24-month period for individuals currently using a hybrid closed loop device

Primary Outcome Measure

epinephrine (pg/ml) [ Time Frame: measured during the clamp studies at 0 (baseline), 12, and 24 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92037
Jeremy H Pettus, MD
[email protected]
858-246-2160
Jeremy H Pettus, MD (PRINCIPAL_INVESTIGATOR)
AdventHealthOrlandoFlorida32804
Brooke Hartwell
[email protected]
407-303-2519
Richard E Pratley, MD (PRINCIPAL_INVESTIGATOR)
Anna Casu, MD (PRINCIPAL_INVESTIGATOR)
University of KentuckyLexingtonKentucky40508
Simon Fisher, MD, PhD
[email protected]
859-562-0473
Simon Fisher, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55455
Sarah Zaun
[email protected]
612-301-7040
Elizabeth R Seaquist, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Cornelia (Ginger) Dalton-Bakes
[email protected]
215-746-2085
Michael R Rickels, MD, MS (PRINCIPAL_INVESTIGATOR)

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