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

NCT07287943 | Recruiting DMC FDA Device

• 1 other identifier: 28244
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Gastroparesis Due to Diabetes Mellitus Type I; Type 1 Diabetes

Keywords

type 1 diabetes; gastroparesis

Outcome Measures

Primary Outcomes (1)

• Time in Range (70-180 mg/dL)

  Percentage of time that sensor glucose values are within the target range of 70-180 mg/dL, as measured by continuous glucose monitoring (CGM).

  Baseline to 3 months

Secondary Outcomes (6)

• HbA1c

  Baseline to 3 months

• Mean Sensor Glucose

  Baseline to 3 months

• Time in Tight Target Range (70-140 mg/dL)

  Baseline to 3 months

• Time Above Range

  Baseline to 3 months

• Time Below Range

  Baseline to 3 months

Other Outcomes (2)

• Severe Hypoglycemia

  3 months

• Diabetic Ketoacidosis

  3 months

Study Arms (2)

Medtronic 780G group

EXPERIMENTAL

Device: Medtronic 780G AID

Usual care

NO INTERVENTION

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

Interventions

Medtronic 780G AID DEVICE

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

Medtronic 780G group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Viral N. Shah: lead
• Medtronic: collaborator

Study Sites (1)

Indiana University Health, Univeristy hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Gastroparesis

Interventions

Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Central Study Contacts

Sana Kalaji

CONTACT

317-278-6017; skalaji@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 17, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)