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Recruiting

NCT Number: NCT07287943

To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health, Univeristy hospital

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Viral Shah, MD

CONTACT

[email protected]

317-278-6017

Viral Shah, MD

PRINCIPAL_INVESTIGATOR

Zunera Tariq, MD

CONTACT

[email protected]

317-278-0907

Zunera Tariq, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

Medtronic 780G AID

Device

Participants in Medtronic AID treatment group will use it for three months

Primary outcomes

  1. 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 outcomes

  1. HbA1c

    Time frame: Baseline to 3 months

    Change in glycated hemoglobin (HbA1c) measured using standard laboratory methods.

  2. Mean Sensor Glucose

    Time frame: Baseline to 3 months

    Mean sensor glucose value derived from CGM data.

  3. 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.

  4. 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.

  5. 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.

  6. Glucose Variability

    Time frame: Baseline to 3 months

    Glucose variability assessed by the standard deviation (SD) of sensor glucose values from CGM data.

Other outcomes

  1. Severe Hypoglycemia

    Time frame: 3 months

    Number of severe hypoglycemic events requiring assistance from another person.

  2. Diabetic Ketoacidosis

    Time frame: 3 months

    Number of diabetic ketoacidosis events defined by standard clinical criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Sana Kalaji

CONTACT

[email protected]

317-278-6017

Sponsors and collaborators

Lead sponsor

Viral N. Shah

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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