New study tests smart insulin pumps and training to restore low blood sugar warning signs
NCT ID NCT06325202
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether combining automated insulin pumps (Omnipod 5 or Medtronic 780G) with specialized education can help adults with type 1 diabetes who have lost the ability to feel low blood sugar (hypoglycemia). The trial will enroll 324 participants and follow them for up to 24 months, measuring hormone responses and symptom awareness. The goal is to restore the body's natural warning system for dangerously low glucose levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Omnipod 5 or Medtronic 780G automated insulin delivery system, plus My HypoCOMPaSS or HARPdoc education program
- What this could lead to
- If successful, this could help people with type 1 diabetes regain the ability to sense low blood sugar, reducing dangerous episodes and improving daily safety.
- What could go wrong
- This is a mid-sized study, not a cure. Results may vary, and the education programs may not work for everyone. The devices require ongoing use and management.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 324 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2025
- Expected to finish
-
Jul 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Clinical diagnosis of type 1 diabetes * Gold Score or Clarke Score ≥ 4 (highly associated with IAH) * Random non-fasting C-peptide \< 200 pmol/L * Diabetes duration ≥ 10 years * HbA1c \< 10.5% * Total Daily Insulin Dose of \< 1 unit/kg * Ability to read and speak English (because validated non-English versions of the cognitive tests and the educational interventions are not available) Exclusion Criteria: * Medical conditions that limit participation in study activities, as determined by the PI (including but not limited to cognitive dysfunction, reduced hearing, reduced vision, cancer under active treatment, untreated angina, organ failure) * Active alcohol or drug abuse (as defined by DSM criteria of either 1) recurrent use of alcohol/drugs resulting in a failure to fulfill major role obligations at work, school, or home, 2) recurrent alcohol/drug use in situations in which it is physically hazardous, or 3) recurrent alcohol or drug-related legal problems) * Social determinants of health that limit participation in study activities, as determined by the PI (including but not limited to homelessness, food insecurity, inadequate social support) * Seizure disorder unrelated to hypoglycemia associated seizures, unless documented seizure-free for \>12 months and on a stable regimen of anti-convulsant therapy * Skin conditions that would preclude the use of a CGM * Super-physiologic exposure to steroids within one month of enrollment * eGFR \< 45 mL/min/1.73 m2 * History of bariatric surgery that irreversibly alters gut innervation and structure * Hyper- or hypokalemia (serum potassium \>5.5 or \<3.5 mmol/L)\* * Hemoglobin \< 10 g/dL\* * Medical condition that requires intermittent or continuous use of glucocorticoids at greater than physiological replacement doses * Pregnancy, plan for pregnancy, or breast feeding * Abnormal thyroid function tests of clinical significance, as determined by PI\* * Liver transaminases \> 3 times the upper limit of normal\* * Hospitalization for mental illness in last year * History of adrenalectomy * At discretion of the PI, laboratory tests may be repeated once. If the participant is not eligible after the second attempt, then the participant. The participant may be screened again.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetes mellitus, type 1 are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
8 sites in 3 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
-
AdventHealth
RECRUITINGOrlando, Florida, 32804, United States
-
University of California, San Diego
RECRUITINGLa Jolla, California, 92037, United States
-
University of Kentucky
RECRUITINGLexington, Kentucky, 40508, United States
-
University of Leicester
RECRUITINGLeicester, LE5 4PW, United Kingdom
-
University of Melbourne
RECRUITINGFitzroy, Victoria, 3065, Australia
-
University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55455, United States
Contact Email: •••••@•••••
-
University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
-
University of Sheffield
RECRUITINGSheffield, S10 2RX, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a glucose app that predicts lows calm diabetes fears?
- Could type 1 diabetes hide liver problems in children?
- Can a Weight-Loss drug slow stomach emptying in type 1 diabetes?
- Can pressurized oxygen tame blood sugar spikes?
- Could a virtual life-coach program help young adults tame type 1 diabetes?
- Can Real-World data improve diabetes care in pregnancy?