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Back to study searchNCT07287943
RecruitingNCT07287943ClinicalTrials.gov record

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

THE QUICK READ

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
Understand screening

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

Prepare your questions

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.

No results are flagged as posted.

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
Zunera Tariq, MDCONTACTtariqz@iu.edu317-278-0907
Viral Shah, MDCONTACTtariqz@iu.edu317-278-6017
Viral Shah, MDPRINCIPAL_INVESTIGATOR
Zunera Tariq, MDSUB_INVESTIGATOR
View location on map ↗

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

Sana KalajiCONTACTskalaji@iu.edu317-278-6017
Official study title

Efficacy and Safety of Medtronic 780G Automated Insulin Delivery System in Adults With Type 1 Diabetes and Gastroparesis

A HUMAN NEXT STEP

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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