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

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

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

Conditions3

Locations1 site

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