Medtronic 780G automated insulin delivery for adults with type 1 diabetes and gastroparesis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with longstanding type 1 diabetes and a clinical diagnosis of gastroparesis are enrolled and randomized to use the Medtronic 780G automated insulin delivery system or usual care, with continuous glucose monitoring required. Participants must have HbA1c ≥8.0% and be willing to use the Simplera CGM with the device; those already on pumps randomized to control may be asked to use manual pump mode. The study follows participants over its intervention period collecting measures of blood sugar control and safety events, including hypoglycemia and device-related issues. Results will compare glycemic outcomes and adverse events between the 780G group and usual care to determine benefit and tolerability in this specific population.

Why it matters

Who can join: the full rules

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

Where it's running

• Indiana University Health, Univeristy hospital
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Study coordinator: Sana Kalaji
• Email: skalaji@iu.edu
• Phone: 317-278-6017

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.