- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03092310
Feasibility Evaluation of an Artificial Pancreas With Glucose Prediction Trust Index
Feasibility Evaluation of an Artificial Pancreas With an Enhanced Model Predictive Control (eMPC) Controller and a Health Monitoring System (HMS) With a Glucose Prediction Trust Index
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a feasibility study of an artificial pancreas (AP) system with our previously validated target eMPC and HMS algorithms, with the addition of a trust index of the predicted glucose value integrated into the portable Artificial Pancreas System (pAPS). The system will be evaluated on up to 20 subjects, with the goal of 10 subjects completing a 48-hour closed-loop session at one clinical site (William Sansum Diabetes Center). During the session subjects will bolus for all meals and snacks and perform a 45-minute walking session.
The purpose of this pilot study is to establish that closed-loop insulin delivery with a target enchanted model predictive control (eMPC)/Health Monitoring System (HMS) algorithms with a trust index of the predicted glucose value is safe and effective, to analyze and learn to improve upon the accuracy of the predicted glucose values, and to collect efficacy data to inform a future larger study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Santa Barbara, California, United States, 93105
- William Sansum Diabetes Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 and ≤ 75 years at the time of screening.
- Clinical diagnosis of type 1 diabetes for at least one year.
- Has been using an insulin pump for at least 6 months at the time of screening.
- HbA1c < 10%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit, or if already completed within 2 months of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
- Serum creatinine of < 2.0 mg/dL. Serum creatinine will be assessed at the screening visit, or if already completed within 2 months of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
- Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate.
- Willing to perform at least 7 fingerstick blood glucose tests a day.
- Willing to refrain from taking acetaminophen products for the duration of the clinical trial. If acetaminophen is taken, subject is to avoid making any insulin dosing decisions based on CGM for at least 12 hours.
- Willing to abide by the study protocol and use study-provided devices, including the Omnipod, Dexcom CGM, glucometer, ketone meter and pAPS tablet.
Exclusion Criteria:
- Pregnancy
- 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.
- Known unstable cardiac disease or untreated cardiac disease, as revealed by history or physical examination.
- Dermatological conditions that would preclude wearing a CGM sensor or Pod.
- One or more seizures in the past year.
- Screening A1c ≥ 10% or serum creatinine ≥ 2.0 mg/dL.
- Any condition that could interfere with participating in the trial, based on investigator judgment.
- Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals), defined as using any of these medications within 30 days of the screening visit or during the study.
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Artificial Pancreas
The artificial pancreas device will employ its enhanced Model Predictive Control (MPC) algorithm with a target glucose level of 110 mg/dL with a trust index for MPC-predicted glucose values, weighing future glucose predictions and only acting on predictions with higher weight in the trust index.
The Health Monitoring System algorithm uses the same CGM data as the MPC control algorithm but utilizes a separate algorithm for trending and predictions of future glucose values.
Using a redundant and independent algorithm is an important safety feature of the overall AP device.
|
Artificial Pancreas Device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent time within the target glucose range of 70-180 mg/dl overall as assessed by continuous glucose monitoring (CGM).
Time Frame: 48 hours
|
The primary endpoint for this pilot study will be time within the target glucose range of 70-180 mg/dl overall as assessed by continuous glucose monitoring (CGM), during closed-loop use, determining if the combination of eMPC and the assessment of trust index can provide safe and effective glucose control.
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the trust index predictions vs. standard eMPC glucose predictions.
Time Frame: 48 hours
|
During closed-loop use, assessment of the trust index predictions vs. standard eMPC glucose predictions (frequency of moving away from nominal weights of predicted glucose).
|
48 hours
|
Frequency of hypoglycemia during closed-loop use.
Time Frame: 48 hours
|
Frequency of hypoglycemia during closed-loop use, defined as percent time glucose is below predefined thresholds of 70 mg/dl, 60 mg/dl and 50 mg/dL.
|
48 hours
|
Frequency of hyperglycemia during closed-loop use.
Time Frame: 48 hours
|
Frequency of hyperglycemia during closed-loop use, defined as percent time glucose is above predefined thresholds of 180 mg/dl, 250 mg/dl, and 300 mg/dL.
|
48 hours
|
Percent time within the target glucose range of 70-140 mg/dl during closed-loop use.
Time Frame: 48 hours
|
Percent time within the target glucose range of 70-140 mg/dl overall as assessed by continuous glucose monitoring (CGM), during closed-loop use.
|
48 hours
|
Percent time glucose is within range 70-150 mg/dl postprandial within 5 hours following meals, during closed-loop use.
Time Frame: 48 hours
|
Percent time glucose is within range 70-150 mg/dl postprandial within 5 hours following meals, during closed-loop use.
|
48 hours
|
Standard Deviation and Coefficient of Variation of glucose values
Time Frame: 48 hours
|
To measure glycemic variability, the standard deviation and coefficient of variation of glucose values (as measured by continuous glucose monitoring) will be determined during the 48 hours of closed-loop use.
|
48 hours
|
Markers of hypo- and hyperglycemia
Time Frame: 48 hours
|
Markers of hypo- and hyperglycemia, to include LBGI (Low blood glucose index) and HBGI (High blood glucose index), during closed-loop use.
|
48 hours
|
Insulin Doses Given
Time Frame: 48 hours
|
Change in total daily doses and post prandial insulin doses given during the 48 hours of closed-loop use.
|
48 hours
|
Number of treatments given for hypoglycemia (defined as carbohydrates given for treatment of a documented or suspected low blood sugar), during the 48 hours of closed-loop use.
Time Frame: 48 hours
|
Treatments for hypoglycemia given during the 48 hours of closed-loop use.
Hypoglycemia treatments may be given in response to alerts from the HMS, if blood glucose < 70 mg/dL, or at the request of the subject or investigator.
|
48 hours
|
Number of alerts given by the HMS to prevent hypoglycemia
Time Frame: 48 hours
|
Number of alerts given by the HMS to prevent hypoglycemia during closed-loop use.
|
48 hours
|
Failure analysis of the devices/connectivity issues that may occur (# disconnects and device restarts).
Time Frame: 48 hours
|
Failure analysis of the devices/connectivity issues that may occur during closed-loop use.
This includes number of CGM communication losses with 3 or more missed points, and number of times the entire system required a restart.
|
48 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Eyal Dassau, PhD, Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University
- Principal Investigator: Francis J Doyle III, PhD, Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University
- Principal Investigator: Alejandro Leguna, PhD, Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00020556
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.
Clinical Trials on Type 1 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
University of California, San FranciscoJuvenile Diabetes Research FoundationCompletedType 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMUnited States, Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
Spiden AGDCB Research AGRecruitingType 1 Diabetes Mellitus | Type 1 Diabetes Mellitus With Hypoglycemia | Type 1 Diabetes Mellitus With HyperglycemiaSwitzerland
-
Hoffmann-La RocheRoche DiagnosticsCompletedDiabetes Mellitus Type 2, Diabetes Mellitus Type 1Germany
Clinical Trials on Artificial Pancreas Device
-
Kochi UniversityUniversity of Tokushima; Oita UniversityUnknownCardiovascular Diseases | Pancreatic DiseaseJapan
-
Sansum Diabetes Research InstituteJuvenile Diabetes Research Foundation; Schneider Children's Medical Center,...CompletedDiabetes Mellitus, Type 1United States, Israel
-
McGill University Health Centre/Research Institute...Juvenile Diabetes Research FoundationCompleted
-
Oregon Health and Science UniversityXeris PharmaceuticalsCompleted
-
University of VirginiaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); DexCom... and other collaboratorsRecruitingType 1 DiabetesUnited States
-
Huazhong University of Science and TechnologyCompleted
-
Sansum Diabetes Research InstituteHarvard UniversityCompleted
-
Johns Hopkins UniversityIcahn School of Medicine at Mount SinaiCompletedMorbid ObesityUnited States
-
Nemours Children's ClinicJaeb Center for Health ResearchRecruitingDiabetes Mellitus, Type 1 | Child | Delivery of Health Care | Equipment and SuppliesUnited States
-
Rensselaer Polytechnic InstituteUniversity of Colorado, Denver; Stanford University; Mount Sinai Hospital, New...CompletedType 1 Diabetes