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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Type 1 Diabetes
    Gastroparesis Due to Diabetes Mellitus Type I

NCT07287943

Viral N. Shah

13 May 2026

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