RecruitingNot ApplicableNCT07287943
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Efficacy and Safety of Medtronic 780G Automated Insulin Delivery System in Adults With Type 1 Diabetes and Gastroparesis
Sponsor
Viral N. Shah
Enrollment
34 participants
Start Date
Feb 9, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- Age ≥18 years
- Diagnosis of T1D for at least 12 months with stable insulin regimen for at least 2 months
- HbA1c ≥8.0%
- Diagnosis of gastroparesis per National Institute of Health (NIH) definition
- Willing 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 on an insulin pump already, should be willing to use pump in manual mode only for the duration of the study
Exclusion Criteria12
- Age \<18 years
- Current use of inhaled insulin (Afrezza)
- Patients with T1D using any glucose lowering medications other than insulin at the time of screening
- Pregnancy, breast feeding, or wanting to become pregnant
- Current use (≥ 2 weeks of continuous use) of any steroidal medication, or anticipated long-term steroidal treatment (\>4 weeks continuously), during the study period
- History of gastric outlet obstruction or other gastrointestinal structural abnormalities
- Estimated glomerular filtration rate (eGFR) \<30 or on dialysis
- History of SH in the previous 3 months
- History of two or more episodes DKA requiring hospitalization in the past 12 months
- Any medical (such as severe cardiovascular disease, malignancy, chronic liver disease) or psychosocial conditions that make a person unfit for the study at the discretion of investigators
- Use of investigational drugs within 5 half-lives prior to screening
- Current use of cannabis or history of cannabinoid hyperemesis syndrome
Interventions
DEVICEMedtronic 780G AID
Participants in Medtronic AID treatment group will use it for three months
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07287943
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