Recruiting

Medtronic 780G

Sponsor:

Viral N. Shah

Code:

NCT07287943

Conditions

Type 1 Diabetes

Gastroparesis Due to Diabetes Mellitus Type I

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medtronic 780G AID

Study Details

Brief summary:

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.

Conditions

Type 1 Diabetes

Gastroparesis Due to Diabetes Mellitus Type I

Study ID

NCT07287943

Start date

Feb 9, 2026

Status verified date

Oct, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Medtronic 780G group

no intervention: Usual care

Participants will continue either multiple daily injections or non-AID insulin pumps

Interventions

Medtronic 780G AID

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

Primary outcome measure

  • Time in Range (70-180 mg/dL) [ Time Frame: Baseline to 3 months ]

Central Contacts and Locations

Central contacts

Sana Kalaji

317-278-6017skalaji@iu.edu

Locations

Indiana University Health, Univeristy hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Zunera Tariq, MD

317-278-0907tariqz@iu.edu

Viral Shah, MD

317-278-6017tariqz@iu.edu

Principal Investigator:

Viral Shah, MD

More Information

Sponsor

Viral N. Shah

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Keywords

  • type 1 diabetes
  • gastroparesis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by Viral N. Shah on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.