Medtronic 780G automated insulin delivery for adults with type 1 diabetes and gastroparesis
Efficacy and Safety of Medtronic 780G Automated Insulin Delivery System in Adults With Type 1 Diabetes and Gastroparesis
This trial will try the Medtronic 780G automated insulin delivery system in adults with type 1 diabetes and gastroparesis to see if it improves blood sugar control and is safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07287943 on ClinicalTrials.gov |
What this trial studies
Adults with longstanding type 1 diabetes and a clinical diagnosis of gastroparesis are enrolled and randomized to use the Medtronic 780G automated insulin delivery system or usual care, with continuous glucose monitoring required. Participants must have HbA1c ≥8.0% and be willing to use the Simplera CGM with the device; those already on pumps randomized to control may be asked to use manual pump mode. The study follows participants over its intervention period collecting measures of blood sugar control and safety events, including hypoglycemia and device-related issues. Results will compare glycemic outcomes and adverse events between the 780G group and usual care to determine benefit and tolerability in this specific population.
Who should consider this trial
Good fit: Adults (≥18 years) with type 1 diabetes for at least 12 months, HbA1c ≥8.0%, a diagnosis of gastroparesis per NIH criteria, and willingness to use the Medtronic 780G with Simplera CGM are ideal candidates.
Not a fit: People who are pregnant or planning pregnancy, using inhaled or noninsulin glucose-lowering drugs, on prolonged steroid therapy, or with gastric outlet obstruction or other excluded GI structural abnormalities are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the 780G system could improve blood sugar control and reduce dangerous low and high blood sugar episodes for adults with type 1 diabetes and gastroparesis.
How similar studies have performed: Automated insulin delivery systems like the 780G have improved glycemic control in broader type 1 diabetes populations, but applying the 780G specifically to patients with gastroparesis is largely novel and not well-studied.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Indianapolis, Indiana
- Indiana University Health, Univeristy hospital — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Sana Kalaji
- Email: skalaji@iu.edu
- Phone: 317-278-6017
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.