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Recruiting NCT07287943

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

No phase Interventional Type 1 Diabetes Gastroparesis Due to Diabetes Mellitus Type I

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medtronic 780G AID.
Who it may be relevant to
Registry conditions: Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Medtronic 780G AID
    Participants in Medtronic AID treatment group will use it for three months

Primary outcome measures

  • Time in Range (70-180 mg/dL) [Time frame: Baseline to 3 months]
Secondary outcome measures (6)
  • HbA1c [Time frame: Baseline to 3 months]
  • Mean Sensor Glucose [Time frame: Baseline to 3 months]
  • Time in Tight Target Range (70-140 mg/dL) [Time frame: Baseline to 3 months]
  • Time Above Range [Time frame: Baseline to 3 months]
  • Time Below Range [Time frame: Baseline to 3 months]
  • Glucose Variability [Time frame: Baseline to 3 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Indiana University Health, Univeristy hospital — Indianapolis

Identifiers

NCT: NCT07287943 · 28244

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗