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NCT07287943NARecruiting

To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.

Viral N. Shah

Start Date

2/9/2026

Completion Date

12/1/2026

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 Criteria

Age Range: 18 years to No maximum

Inclusion criteria * 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 criteria * 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

DEVICE

Medtronic 780G AID

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Conditions

Type 1 DiabetesGastroparesis Due to Diabetes Mellitus Type I

Locations

Indiana University Health, Univeristy hospital

Indianapolis, Indiana 46202

United States