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

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.

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