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Type 1 Diabetes MellitusNCT03092310

Feasibility Evaluation of an Artificial Pancreas With Glucose Prediction Trust Index

A study testing Artificial Pancreas Device in people with Type 1 Diabetes Mellitus, run by Sansum Diabetes Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Artificial Pancreas Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
20 Mar 2017to 20 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • William Sansum Diabetes Center

    Santa Barbara, California, 93105

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Artificial Pancreas Device
Keywords
Artificial Pancreas
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial Pancreas DeviceDevice

    Artificial Pancreas Device

Study groups in NCT03092310
Study groupRoleWhat they receive
Artificial PancreasExperimentalThe 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.
Receives: Device: Artificial Pancreas Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 48 hours

Secondary outcomes (11)

  1. 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).

    Measured: 48 hours

  2. 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.

    Measured: 48 hours

  3. 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.

    Measured: 48 hours

  4. 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.

    Measured: 48 hours

  5. 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.

    Measured: 48 hours

  6. 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.

    Measured: 48 hours

  7. 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.

    Measured: 48 hours

  8. Insulin Doses Given

    Change in total daily doses and post prandial insulin doses given during the 48 hours of closed-loop use.

    Measured: 48 hours

  9. 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.

    Measured: 48 hours

  10. Number of alerts given by the HMS to prevent hypoglycemia

    Number of alerts given by the HMS to prevent hypoglycemia during closed-loop use.

    Measured: 48 hours

  11. 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.

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2017
  2. Study start20 Mar 2017
  3. Primary completion20 Dec 2017
  4. Study completion20 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03092310
Sponsor's protocol ID
Pro00020556
Status last verified
Jul 2018
First submitted
15 Mar 2017
Last updated
12 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 29958023

Questions about this trial

What is this clinical trial studying?

A study testing Artificial Pancreas Device in people with Type 1 Diabetes Mellitus, run by Sansum Diabetes Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent time within the target glucose range of 70-180 mg/dl overall as assessed by continuous glucose monitoring (CGM). (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03092310, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.

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