Efficacy And Safety Of Medtronic 780G Automated Insulin Delivery System In Adults With Type 1 Diabetes And Gastroparesis

Study on Automated Insulin Delivery System for Type 1 Diabetes with Gastroparesis

V
Viral Shah

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
34 participants needed
3 Locations

Brief description of study

The primary objective of this research is to study efficacy of Medtronic 780 G system in patients with type 1 Diabetes and gastroparesis (slow gastric emptying) compared to usual care (either multiple daily insulin injections or non Medtronic insulin pump therapy).

THIS STUDY IS ENROLLING BY INVITATION ONLY - Study team will review GI and Endo clinic patient lists to see if they have type 1 diabetes and gastroparesis. Subjects will be contacted and recruited from Endocrinology and GI group by the study team.

Detailed description of study

This will a prospective, open label, randomized clinical trial with 1:1 randomization to an intervention group using the study Medtronic 780G AID system versus usual care (either multiple daily injections (MDI) or insulin pump along with continuous glucose monitoring (CGM) for 12 weeks. In brief, there are up to three in-person research visits and up to four phone call visits. 
 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Type I Diabetes, T1D, Gastroparesis
  • Age: 18 years - 100 years
  • Gender: All

Inclusion criteria 
1)    Age ≥18 years 
2)    Diagnosis of T1D for at least 12 months with stable insulin regimen for at least 2 months
3)    HbA1c ≥8.0% 
4)    Diagnosis of gastroparesis per National Institute of Health (NIH) definition for at least 2 years. 
5)    Willing to use Medtronic 780G system either with Guardian Connect 4 or Simplera CGM.
6)    Ability to provide informed consent before any trial-related activities
7)    If randomized to usual care group and on and insulin pump already, should be willing to use pump in manual mode only for the duration of the study

Exclusion criteria 
1)    Age 2)    Current use of inhaled insulin (Afrezza)
3)    Patients with T1D using any glucose lowering medications other than insulin at the time of screening 
4)    Pregnancy, breast feeding, or wanting to become pregnant 
5)    Current use (≥ 2 weeks of continuous use) of any steroidal medication, or anticipated long-term steroidal treatment (>4 weeks continuously), during the study period
6)    History of gastric outlet obstruction or other gastrointestinal structural abnormalities 
7)    Estimated glomerular filtration rate (eGFR) 8)    History of SH in the previous 3 months
9)    History of two or more episodes DKA requiring hospitalization in the past 12 months 
10)    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 
11)    Use of investigational drugs within 5 half-lives prior to screening
12)    Current use of cannabis or history of cannabinoid hyperemesis syndrome 

This study investigates an automated insulin delivery system in adults with Type 1 diabetes and gastroparesis. Type 1 diabetes is a chronic disease where the body's defense system mistakenly attacks specific cells within the pancreas, which make insulin. Insulin helps control sugar in the blood. When these cells are damaged, they cannot make enough insulin. This means people with Type 1 diabetes need to take insulin every day to keep their blood sugar at safe levels. Gastroparesis is a condition where the stomach takes longer to empty its contents, causing symptoms like nausea and bloating. The purpose of this study is to compare the effectiveness of an investigational insulin delivery system with usual care methods.

Participants in the study will be randomly assigned to one of two study arms. One arm will use the investigational insulin delivery system, while the other will continue with their usual care, which may include daily insulin injections or an insulin pump with continuous glucose monitoring. The study will involve up to three in-person visits and up to four phone call visits to monitor progress and collect data.

  • Who can participate: Adults aged 18 and older with Type 1 diabetes for at least 12 months and gastroparesis for at least 2 years can participate. Participants must have an HbA1c of 8.0% or higher and be willing to use the investigational insulin delivery system.
  • Study details: Participants will either use the investigational insulin delivery system or continue with their usual care, which involves insulin injections or pump therapy. If using a pump, it must be in manual mode for the study duration. A placebo is not used in this study.
  • Study timelines and visits: The study will last 12 weeks. The study requires 3 visits.
Updated on 10 Jun 2026. Study ID: PENDO-IIR-MEDTRONIC-780G, 28244
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only