No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
34 (estimated)
Sponsor
Viral N. Shah · Other
Who this trial is looking for
This trial is looking for adults with type 1 diabetes and gastroparesis to test the Medtronic 780G insulin pump. Participants will need to use the pump for their diabetes management during the study.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have type 1 diabetes diagnosed for at least 12 months.
I have been on a stable insulin regimen for at least 2 months.
My HbA1c is 8.0% or higher.
I have gastroparesis as defined by the National Institute of Health.
I am willing to use the Medtronic 780G system.
I can provide informed consent before starting the trial.
If in the usual care group, I can use my existing pump in manual mode.
You may not be able to join if
I am under 18 years old.
I currently use inhaled insulin (Afrezza).
I take any glucose lowering medications other than insulin.
I am pregnant, breastfeeding, or planning to become pregnant.
I have used any steroid medication continuously for the past 2 weeks.
I have a history of gastric outlet obstruction or similar issues.
My kidney function is severely impaired (eGFR < 30) or I am on dialysis.
I have had two or more hospitalizations for DKA in the past year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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 p…
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
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