- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03767790
Model Predictive Control (MPC) Artificial Pancreas vs. Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) With Different Food Choices in the Outpatient Setting
A Randomized Crossover Comparison of Model Predictive Control (MPC) Artificial Pancreas vs. Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) With Different Food Choices in the Outpatient Setting
Study Overview
Detailed Description
The goal of this study is to compare the efficacy and safety of an AID system using a MPC algorithm versus SAP/PLGS therapy with different food choices over a 4 week period.
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.
In this study, during each two-week period, subjects will be given pre-weighed portions of different meals to eat (either regular semolina pasta or extra-long grain white rice) with detailed cooking instructions, and will eat these meals on 6 different occasions for dinner. They will bolus as they normally do for these meals. This will allow us to observe the postprandial meal response when using sensor-augmented pump (SAP) or iAPS, showing the importance of nutrition choices with modern technological treatments in T1D.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Santa Barbara, California, United States, 93105
- Sansum Diabetes Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year.
- Using an insulin pump for at least 3 months at the time of screening. Insulin pump use includes use of automated features, to include predictive or threshold low-glucose suspend or hybrid closed-loop with without a Dexcom sensor.
- Familiarity and use of a carbohydrate ratio for meal boluses.
- Age ≥18.0 years old
- HbA1c < 10.5%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit, or if already completed within 2 weeks of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
- For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- Willingness to switch home pump to PLGS or full manual mode if using hybrid closed-loop with an FDA approved system.
- Have an emergency contact living at home with the subject who will be available to be contacted by the study staff overnight in the event of an emergency.
- Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, to include having basic cooking equipment at home to prepare the study meals.
- Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study.
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
Exclusion Criteria:
- Use of an unapproved closed-loop insulin delivery system within 2 weeks before screening or during the study is not allowed.
- Gastrointestinal disease such as celiac disease or multiple food allergies.
- Any form of gluten sensitivity or wheat allergy.
- Allergies to any form of nuts or ingredients present in the study meals (tomatoes etc).
- History of difficulty digesting food.
- Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder
- One or more episodes of hypoglycemia requiring an emergency room visit or hospitalization in the past 6 months.
- One or more episodes of hyperglycemia requiring an emergency room visit or hospitalization in the past 6 months.
- Self-reported or clinically documented hypoglycemia unawareness.
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Automated Insulin Delivery
Participants will use the Automated Insulin Delivery (AID) iAPS system for 2 weeks in the outpatient setting.
During AID use, subjects will consume 6 study meals (3 meals of each meal type in assigned random order, 1-2 portions per meal,) at dinner time over the 2-week period in a pre-assigned random order, and document on the study meal forms when they consume each numbered meal.
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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.
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NO_INTERVENTION: SAP/PLGS
Participants will use their home pump with a CGM sensor (sensor augmented pump) or in Predictive Low Glucose Suspend (PLGS) mode if their home pump supports this mode, for 2 weeks in the outpatient setting.
During these 2 weeks, subjects will consume 6 study meals (3 meals of each meal type in assigned random order, 1-2 portions per meal,) at dinner time over the 2-week period in a pre-assigned random order, and document on the study meal forms when they consume each numbered meal.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time in target glucose range
Time Frame: 4 weeks
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Time in target glucose range 70-180 mg/dL measured by CGM to determine safety and efficacy of the integrated system
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial glucose peak
Time Frame: 4 weeks
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Postprandial glucose peak rise (highest measurement in mg/dL) from baseline glucose (mg/dl) for the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS
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4 weeks
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Time to postprandial glucose peak
Time Frame: 4 weeks
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Time (minutes) to postprandial glucose (highest measurement in mg/dL) rise from baseline glucose (mg/dl) during the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS
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4 weeks
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Postprandial Area Under the Curve
Time Frame: 4 weeks
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Area Under the Curve Glucose (mg/dl x min) for the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS
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4 weeks
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Postprandial time for glucose to return to baseline
Time Frame: 4 weeks
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Time (minutes) for CGM glucose to return to baseline (starting value) after the study meals, during both use of SAP/PLGS and when using the iAPS
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4 weeks
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Glucose < 70 mg/dL
Time Frame: 4 weeks
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Percent time GGM glucose < 70 mg/dL
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4 weeks
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Glucose < 54 mg/dL
Time Frame: 4 weeks
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Percent time GGM glucose < 54 mg/dL
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4 weeks
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Glucose > 180 mg/dL
Time Frame: 4 weeks
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Percent time GGM glucose > 180 mg/dL
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4 weeks
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Glucose > 250 mg/dL
Time Frame: 4 weeks
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Percent time GGM glucose > 250 mg/dL
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4 weeks
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Serious adverse events (SAE)
Time Frame: 4 weeks
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The total number of serious adverse events during the clinical trial
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4 weeks
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Serious adverse device events (SADE)
Time Frame: 4 weeks
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The total number of serious adverse events related to the study device use during the clinical trial
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4 weeks
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Adverse device effects (ADE)
Time Frame: 4 weeks
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The total number of adverse device effects (ADE) during the clinical trial
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4 weeks
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Unanticipated adverse device effects (UADE)
Time Frame: 4 weeks
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The total number of unanticipated adverse device effects (UADE) during the clinical trial
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4 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total daily insulin use
Time Frame: 4 weeks
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Total daily insulin use (units/day) during both use of SAP/PLGS and when using the iAPS
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4 weeks
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Total basal insulin use
Time Frame: 4 weeks
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Total daily basal insulin use (units/day) during both use of SAP/PLGS and when using the iAPS
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4 weeks
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Total bolus insulin use
Time Frame: 4 weeks
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Total daily bolus insulin use (units/day) during both use of SAP/PLGS and when using the iAPS
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4 weeks
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Sensor Use Time
Time Frame: 4 weeks
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Total hours of CGM sensor use time during both use of SAP/PLGS and when using the iAPS
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4 weeks
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Closed-Loop Active Time
Time Frame: 2 weeks
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Percent time (hours/day) of closed-loop use during the two weeks of iAPS use
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2 weeks
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Device Issues
Time Frame: 4 weeks
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Total number of devices issues during the clinical trial
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4 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Eyal Dassau, PhD, John A. Paulson School of Engineering and Applied Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G180011-S001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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