Gastroparesis Due to Diabetes Mellitus Type I, Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, gastroparesis
Brief 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.
Interventions
DEVICEMedtronic 780G AID
Participants in Medtronic AID treatment group will use it for three months
Sponsors
Viral N. Shah
Medtronic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range (70-180 mg/dL) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Below Range | Baseline to 3 months | Percentage of time that sensor glucose values are \<70 mg/dL and \<54 mg/dL, measured by CGM. |
| Glucose Variability | Baseline to 3 months | Glucose variability assessed by the standard deviation (SD) of sensor glucose values from CGM data. |
| Time Above Range | Baseline to 3 months | Percentage of time that sensor glucose values are \>180 mg/dL and \>250 mg/dL, measured by CGM. |
| HbA1c | Baseline to 3 months | Change in glycated hemoglobin (HbA1c) measured using standard laboratory methods. |
| Mean Sensor Glucose | Baseline to 3 months | Mean sensor glucose value derived from CGM data. |
| Time in Tight Target Range (70-140 mg/dL) | Baseline to 3 months | Percentage of time that sensor glucose values are between 70 and 140 mg/dL (TTIR), measured by CGM. |
Countries
United States
Contacts
CONTACTSana Kalaji
Outcome results
None listed