Type 1 DiabetesNCT07287943
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
A study testing Medtronic 780G AID in people with Type 1 Diabetes and Gastroparesis Due to Diabetes Mellitus Type I, run by Viral N. Shah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
- What is being tested?
- Medtronic 780G AID
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Health, Univeristy hospital
Indianapolis, Indiana, 46202
Zunera Tariq, MD, 317-278-0907, tariqz@iu.edu
Viral Shah, MD, 317-278-6017, tariqz@iu.edu
About this study
Official title: Efficacy and Safety of Medtronic 780G Automated Insulin Delivery System in Adults With Type 1 Diabetes and Gastroparesis
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.
- Being tested
- Medtronic 780G AID
- Keywords
- type 1 diabetes, gastroparesis
- Medical subject headings
- Diabetes Mellitus, Type 1, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic 780G AIDDevice
Participants in Medtronic AID treatment group will use it for three months
| Study group | Role | What they receive |
|---|---|---|
| Medtronic 780G group | Experimental | Not described Receives: Device: Medtronic 780G AID |
| Usual care | No intervention | Participants will continue either multiple daily injections or non-AID insulin pumps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range (70-180 mg/dL)
Percentage of time that sensor glucose values are within the target range of 70-180 mg/dL, as measured by continuous glucose monitoring (CGM).
Measured: Baseline to 3 months
Secondary outcomes (6)
HbA1c
Change in glycated hemoglobin (HbA1c) measured using standard laboratory methods.
Measured: Baseline to 3 months
Mean Sensor Glucose
Mean sensor glucose value derived from CGM data.
Measured: Baseline to 3 months
Time in Tight Target Range (70-140 mg/dL)
Percentage of time that sensor glucose values are between 70 and 140 mg/dL (TTIR), measured by CGM.
Measured: Baseline to 3 months
Time Above Range
Percentage of time that sensor glucose values are >180 mg/dL and >250 mg/dL, measured by CGM.
Measured: Baseline to 3 months
Time Below Range
Percentage of time that sensor glucose values are <70 mg/dL and <54 mg/dL, measured by CGM.
Measured: Baseline to 3 months
Glucose Variability
Glucose variability assessed by the standard deviation (SD) of sensor glucose values from CGM data.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start9 Feb 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viral N. Shah
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Viral N. Shah, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287943
- Sponsor's protocol ID
- 28244
- Status last verified
- Oct 2026
- First submitted
- 14 Dec 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Will be shared in future
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Medtronic 780G Automated Insulin Delivery System in Adults With Type 1 Diabetes and Gastroparesis
- ClinicalTrials.gov ID
- NCT07287943
- Acronym / sponsor ID
- 28244
- Keywords
- type 1 diabetes, gastroparesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Viral N. ShahUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medtronic 780G group | Experimental | Device: Medtronic 780G AID |
| Usual care | No intervention | –Participants will continue either multiple daily injections or non-AID insulin pumps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic 780G AIDParticipants in Medtronic AID treatment group will use it for three months | Device | Medtronic 780G group |
Primary outcome
Time in Range (70-180 mg/dL)
Time frame: Baseline to 3 months
Percentage of time that sensor glucose values are within the target range of 70-180 mg/dL, as measured by continuous glucose monitoring (CGM).
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No. Will be shared in future
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic 780G AID in people with Type 1 Diabetes and Gastroparesis Due to Diabetes Mellitus Type I, run by Viral N. Shah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sana Kalaji (317-278-6017, skalaji@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Range (70-180 mg/dL) (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.