Clinical trial NCT03092310: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Artificial Pancreas
Lead sponsor: Sansum Diabetes Research Institute
Sponsor class: OTHER
Collaborators: name: Harvard University
First posted: 2017-03-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percent time within the target glucose range of 70-180 mg/dl overall as assessed by continuous glucose monitoring (CGM).
timeFrame: 48 hours
Secondary outcomes:
measure: Assessment of the trust index predictions vs. standard eMPC glucose predictions.
timeFrame: 48 hours
measure: Frequency of hypoglycemia during closed-loop use.
timeFrame: 48 hours
measure: Frequency of hyperglycemia during closed-loop use.
timeFrame: 48 hours
measure: Percent time within the target glucose range of 70-140 mg/dl during closed-loop use.
timeFrame: 48 hours
measure: Percent time glucose is within range 70-150 mg/dl postprandial within 5 hours following meals, during closed-loop use.
timeFrame: 48 hours
measure: Standard Deviation and Coefficient of Variation of glucose values
timeFrame: 48 hours
measure: Markers of hypo- and hyperglycemia
timeFrame: 48 hours
measure: Insulin Doses Given
timeFrame: 48 hours
measure: 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.
timeFrame: 48 hours
measure: Number of alerts given by the HMS to prevent hypoglycemia
timeFrame: 48 hours
measure: Failure analysis of the devices/connectivity issues that may occur (# disconnects and device restarts).
timeFrame: 48 hours
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: William Sansum Diabetes Center
state: California
Study officials:
affiliation: Sansum Diabetes Research Institute
name: Jordan E Pinsker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University
name: Eyal Dassau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University
name: Francis J Doyle III, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University
name: Alejandro Leguna, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.