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

Viral N. Shah

Status: Enrolling

Conditions: Type 1 Diabetes; Gastroparesis Due to Diabetes Mellitus Type I

Treatments: Device: Medtronic 780G AID

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07287943

28244

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Medtronic 780G group

Experimental group

Treatment:

Device: Medtronic 780G AID

Usual care

No Intervention group

Description:

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