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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well the Medtronic 780G automated insulin pump works and how safe it is. It is for adults with type 1 diabetes and gastroparesis, a condition that slows how the stomach empties.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have had type 1 diabetes for at least 12 months, with a steady insulin treatment plan for at least 2 months.
  • Your HbA1c, a measure of average blood sugar, is 8.0% or higher.
  • You have gastroparesis diagnosed using National Institutes of Health guidelines.
  • You are willing to use the Medtronic 780G pump with a Simplera continuous glucose monitor, which tracks blood sugar.
  • You can give informed consent, meaning you understand and agree to the study, before any study activities.
  • If assigned to usual care and already using a pump, you are willing to use it only in manual mode for the whole study.

Who can't join

  • You are under 18, pregnant, breastfeeding, or want to become pregnant.
  • You currently use inhaled insulin (Afrezza) or take any blood sugar-lowering medicine other than insulin.
  • You currently take steroid medicine and have used it continuously for at least 2 weeks, or expect to take it continuously for more than 4 weeks during the study.
  • You have had a blocked stomach outlet or other problems with the structure of your digestive tract. You currently use cannabis or have had repeated vomiting caused by cannabis.
  • Your eGFR, a measure of kidney function, is below 30, or you receive dialysis.
  • You have had severely low blood sugar in the past 3 months, or at least 2 hospital stays for diabetic ketoacidosis (dangerous acid buildup from too little insulin) in the past 12 months.
  • The study team decides that a health, mental health, or social condition makes the study unsuitable for you. Examples include severe heart or blood vessel disease, cancer, or long-term liver disease.
  • You used an experimental drug too close to screening: within 5 half-lives, or 5 times the time it takes your body to clear half the drug.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

IN