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Tests treatment safety and results for Type 1 Diabetes
Official title To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
ClinicalTrials.gov ID: NCT07287943
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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...
- History of gastric outlet obstruction or other gastrointestinal structural abnormalities
See the full eligibility 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 assigned by chance 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.