Back to resultsFeasibility Evaluation of an Artificial Pancreas With Glucose Prediction Trust Index
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Artificial Pancreas Device
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Artificial Pancreas
Eligibility Criteria
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.
Sites / Locations
- William Sansum Diabetes Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Artificial Pancreas
Arm Description
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.
Outcomes
Primary Outcome Measures
Percent time within the target glucose range of 70-180 mg/dl overall as assessed by continuous glucose monitoring (CGM).
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.
Secondary Outcome Measures
Assessment of the trust index predictions vs. standard eMPC glucose predictions.
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).
Frequency of hypoglycemia during closed-loop use.
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.
Frequency of hyperglycemia during closed-loop use.
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.
Percent time within the target glucose range of 70-140 mg/dl during closed-loop use.
Percent time within the target glucose range of 70-140 mg/dl overall as assessed by continuous glucose monitoring (CGM), during closed-loop use.
Percent time glucose is within range 70-150 mg/dl postprandial within 5 hours following meals, during closed-loop use.
Percent time glucose is within range 70-150 mg/dl postprandial within 5 hours following meals, during closed-loop use.
Standard Deviation and Coefficient of Variation of glucose values
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.
Markers of hypo- and hyperglycemia
Markers of hypo- and hyperglycemia, to include LBGI (Low blood glucose index) and HBGI (High blood glucose index), during closed-loop use.
Insulin Doses Given
Change in total daily doses and post prandial insulin doses given during the 48 hours of closed-loop use.
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.
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.
Number of alerts given by the HMS to prevent hypoglycemia
Number of alerts given by the HMS to prevent hypoglycemia during closed-loop use.
Failure analysis of the devices/connectivity issues that may occur (# disconnects and device restarts).
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.
Full Information
NCT ID
NCT03092310
First Posted
March 15, 2017
Last Updated
July 10, 2018
Sponsor
Sansum Diabetes Research Institute
Collaborators
Harvard University
1. Study Identification
Unique Protocol Identification Number
NCT03092310
Brief Title
Feasibility Evaluation of an Artificial Pancreas With Glucose Prediction Trust Index
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sansum Diabetes Research Institute
Collaborators
Harvard University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Artificial Pancreas
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Artificial Pancreas
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Artificial Pancreas Device
Intervention Description
Artificial Pancreas Device
Primary Outcome Measure Information:
Title
Percent time within the target glucose range of 70-180 mg/dl overall as assessed by continuous glucose monitoring (CGM).
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Assessment of the trust index predictions vs. standard eMPC glucose predictions.
Description
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).
Time Frame
48 hours
Title
Frequency of hypoglycemia during closed-loop use.
Description
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.
Time Frame
48 hours
Title
Frequency of hyperglycemia during closed-loop use.
Description
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.
Time Frame
48 hours
Title
Percent time within the target glucose range of 70-140 mg/dl during closed-loop use.
Description
Percent time within the target glucose range of 70-140 mg/dl overall as assessed by continuous glucose monitoring (CGM), during closed-loop use.
Time Frame
48 hours
Title
Percent time glucose is within range 70-150 mg/dl postprandial within 5 hours following meals, during closed-loop use.
Description
Percent time glucose is within range 70-150 mg/dl postprandial within 5 hours following meals, during closed-loop use.
Time Frame
48 hours
Title
Standard Deviation and Coefficient of Variation of glucose values
Description
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.
Time Frame
48 hours
Title
Markers of hypo- and hyperglycemia
Description
Markers of hypo- and hyperglycemia, to include LBGI (Low blood glucose index) and HBGI (High blood glucose index), during closed-loop use.
Time Frame
48 hours
Title
Insulin Doses Given
Description
Change in total daily doses and post prandial insulin doses given during the 48 hours of closed-loop use.
Time Frame
48 hours
Title
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.
Description
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.
Time Frame
48 hours
Title
Number of alerts given by the HMS to prevent hypoglycemia
Description
Number of alerts given by the HMS to prevent hypoglycemia during closed-loop use.
Time Frame
48 hours
Title
Failure analysis of the devices/connectivity issues that may occur (# disconnects and device restarts).
Description
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.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan E Pinsker, MD
Organizational Affiliation
Sansum Diabetes Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eyal Dassau, PhD
Organizational Affiliation
Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francis J Doyle III, PhD
Organizational Affiliation
Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alejandro Leguna, PhD
Organizational Affiliation
Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Sansum Diabetes Center
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29958023
Citation
Pinsker JE, Laguna Sanz AJ, Lee JB, Church MM, Andre C, Lindsey LE, Doyle FJ 3rd, Dassau E. Evaluation of an Artificial Pancreas with Enhanced Model Predictive Control and a Glucose Prediction Trust Index with Unannounced Exercise. Diabetes Technol Ther. 2018 Jul;20(7):455-464. doi: 10.1089/dia.2018.0031.
Results Reference
result
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Feasibility Evaluation of an Artificial Pancreas With Glucose Prediction Trust Index
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