Actively Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Led by Viral N. Shah · Updated on 2026-02-18
34
Participants Needed
1
Research Sites
42 weeks
Total Duration
On this page
Sponsors
V
Viral N. Shah
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy and safety of Medtronic 780G automated insulin delivery system in adult persons with type 1 diabetes and gastroparesis.
CONDITIONS
Official Title
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6518 years
- Diagnosis of Type 1 Diabetes for at least 12 months with a stable insulin regimen for at least 2 months
- HbA1c 658.0%
- Diagnosis of gastroparesis according to National Institute of Health (NIH) definition
- Willingness to use Medtronic 780G system either with Simplera CGM
- Ability to provide informed consent before any trial-related activities
- If randomized to usual care group and already using an insulin pump, willingness to use it in manual mode only during the study
You will not qualify if you...
- Age under 18 years
- Current use of inhaled insulin (Afrezza)
- Use of any glucose-lowering medications other than insulin at screening
- Pregnancy, breastfeeding, or planning pregnancy
- Current use (at least 2 weeks continuous) or anticipated long-term use (more than 4 weeks) of steroid medications during the study
- History of gastric outlet obstruction or other gastrointestinal structural abnormalities
- Estimated glomerular filtration rate (eGFR) less than 30 or on dialysis
- History of severe hypoglycemia in the past 3 months
- History of two or more diabetic ketoacidosis episodes requiring hospitalization in the past year
- Any severe medical or psychosocial conditions making the person unfit for the study
- Use of investigational drugs within 5 half-lives before screening
- Current use of cannabis or history of cannabinoid hyperemesis syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Indiana University Health, Univeristy hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
S
Sana Kalaji
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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