NCT07287943 · Viral N. Shah
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
What this study is about
The goal of this clinical trial is to evaluate the effectiveness and safety of Medtronic 780G automated insulin delivery system in adult persons with type 1 diabetes and gastroparesis.
View original scientific description
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.
Interventions
DEVICE
Medtronic 780G AID
Participants in Medtronic AID treatment group will use it for three months
Primary outcome measures
Time in Range (70-180 mg/dL)
Time frame: Baseline to 3 months
Percentage of time that sensor glucose values are within the target range of 70-180 mg/dL, as measured by continuous glucose monitoring (CGM).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Indianapolis, Indiana
Collaborators
Medtronic
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations