Trials / Completed
CompletedNCT04142229
Artificial Pancreas With Different Stress Assessments in the Outpatient Setting
A Randomized Crossover Comparison of Artificial Pancreas vs. Sensor Augmented Pump/Predictive Low Glucose Suspend With Different Stress Assessments in the Outpatient Setting for Patients With Type 1 Diabetes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Sansum Diabetes Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This feasibility study is a randomized crossover trial that will compare the efficacy and safety of an automated insulin delivery (AID) system in patients with type 1 diabetes using a Model Predictive Control (MPC) algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS), and will include different stress induction and assessments over a 4 week period.
Detailed description
Eligible participants will be randomly assigned to one of two treatment arms: 1) AID for two weeks and SAP/PLGS for two weeks , or 2) SAP/PLGS for two weeks and AID for two weeks. During the 4-week trial, subjects will wear the Empatica E4 wristband every day to record electrodermal activity, accelerometer and heartrate data. Subjects will also complete logbooks to record activity and stress. During each two-week period, subjects will come to the clinical center twice for stress induction tests in a medically supervised setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | iAPS | The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices. |
| OTHER | Sensor-Augmented Pump | Subjects will use their home insulin pump and a Dexcom G6 continuous glucose monitoring sensor. |
Timeline
- Start date
- 2019-10-25
- Primary completion
- 2020-11-06
- Completion
- 2020-11-06
- First posted
- 2019-10-29
- Last updated
- 2020-12-01
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04142229. Inclusion in this directory is not an endorsement.