๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion criteria
* Age โฅ18 years
* Diagnosis of T1D for at least 12 months with stable insulin regimen for at least 2 months
* HbA1c โฅ8.0%
* 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 (โฅ 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
Indiana University Health, Univeristy hospital
Indianapolis, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.