To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes · Gastroparesis Due to Diabetes Mellitus Type I
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 34 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean 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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Medtronic 780G group
Not reported in this registry record.
Device: Medtronic 780G AID
Usual care
Participants will continue either multiple daily injections or non-AID insulin pumps
Medtronic 780G AID DEVICE
Participants in Medtronic AID treatment group will use it for three months
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary 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).
Secondary measures
HbA1c
Time frame: Baseline to 3 months
Change in glycated hemoglobin (HbA1c) measured using standard laboratory methods.
Mean Sensor Glucose
Time frame: Baseline to 3 months
Mean sensor glucose value derived from CGM data.
Time in Tight Target Range (70-140 mg/dL)
Time frame: Baseline to 3 months
Percentage of time that sensor glucose values are between 70 and 140 mg/dL (TTIR), measured by CGM.
Time Above Range
Time frame: Baseline to 3 months
Percentage of time that sensor glucose values are \>180 mg/dL and \>250 mg/dL, measured by CGM.
Time Below Range
Time frame: Baseline to 3 months
Percentage of time that sensor glucose values are \<70 mg/dL and \<54 mg/dL, measured by CGM.
Glucose Variability
Time frame: Baseline to 3 months
Glucose variability assessed by the standard deviation (SD) of sensor glucose values from CGM data.
Other measures
Severe Hypoglycemia
Time frame: 3 months
Number of severe hypoglycemic events requiring assistance from another person.
Diabetic Ketoacidosis
Time frame: 3 months
Number of diabetic ketoacidosis events defined by standard clinical criteria.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Indiana University Health, Univeristy hospitalIndianapolis, Indiana, United StatesRecruiting
Study team and timeline
- Lead sponsor
- Viral N. Shah
- Study start
- Feb 9, 2026 Actual
- Primary completion
- Apr 1, 2027 Estimated
- Study completion
- Apr 1, 2027 Estimated
- First posted
- Dec 17, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Efficacy and Safety of Medtronic 780G Automated Insulin Delivery System in Adults With Type 1 Diabetes and Gastroparesis
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026
