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Type 1 Diabetes MellitusPhase 2/3NCT03504046

Safety and Feasibility Evaluation of the APS APP

A Phase 2/3 study testing Artificial Pancreas App 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

This clinical trial is a safety and feasibility study to assess the performance of artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the APS APP platform. 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 App
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
28 Feb 2018to 4 Sep 2018
Phase
Phase 2/3
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 < 10.5%.
  • Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate.
  • Willing to perform at least 7 fingerstick blood glucose tests a day.
Show all 9Show fewer
  • If using Apidra (insulin glulisine) at home and planning to use the Tandem t:AP pump for the closed-loop session, willing to switch to Novolog or Humalog for the closed-loop session.
  • Willing to refrain from taking acetaminophen products for the duration of the clinical trial.
  • Willing to abide by the study protocol and use study-provided devices, including the Omnipod OR Tandem Pump, Dexcom CGM, glucometer, ketone meter and APS APP on the study phone device.

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/infusion site.
  • One or more seizures in the past year.
  • Any condition that could interfere with participating in the trial, based on investigator judgment.
  • 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

  • Sansum Diabetes Research Institute

    Santa Barbara, California, 93105

Other trials in United States

About this study

Official title: Inpatient Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated Into the APS APP

This clinical trial is a safety and feasibility study to assess the performance of artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the APS APP platform.

Read the detailed description

The system will be evaluated on up to 10 adult subjects with type 1 diabetes age 18-75 years old at a single clinical site (Sansum Diabetes Research Institute), who will complete a 48-hour closed-loop (CL) session in an observed CRC environment with medical staff present. During the session subjects will bolus for all meals and snacks and perform a 45-minute walking session while supervised by medical staff. The AP system used consists of an insulin pump, a CGM sensor, and a phone app (the Artificial Pancreas System [APS] phone app).

Being tested
Artificial Pancreas App
Keywords
artificial pancreas, hyperglycemia, hypoglycemia
Medical subject headings
Diabetes Mellitus, Type 1, Hyperglycemia, Hypoglycemia

What participants receive

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

  • Artificial Pancreas AppDevice

    The portable Artificial Pancreas System App (APS APP) is an artificial pancreas system comprised primarily of an insulin pump, a continuous glucose monitor (CGM), and a cellular phone device to connect the components.

Study groups in NCT03504046
Study groupRoleWhat they receive
Artificial Pancreas AppExperimentalAfter completing a 1 week open-loop run in period, subjects will use the APS APP for a 48-hour period in an observed transitional environment.
Receives: Device: Artificial Pancreas App

What is being measured

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

  1. Percent time in glucose range 70-180 mg/dL

    Time in target glucose range overall

    Measured: 48 hours

Secondary outcomes (7)

  1. Percent time in glucose range 80-140 mg/dL overnight

    Overnight time in tight target range

    Measured: 48 hours

  2. Percent time in glucose range 70-150 mg/dl postprandial within 5 hours following meals

    Post prandial time in target

    Measured: 48 hours

  3. Percent time glucose < 70 mg/dL

    Hypoglycemia

    Measured: 48 hours

  4. Percent time glucose < 54 mg/dL

    Significant Hypoglycemia

    Measured: 48 hours

  5. Percent time glucose > 180 mg/dL

    Hyperglycemia

    Measured: 48 hours

  6. Percent time glucose > 250 mg/dL

    Significant Hyperglycemia

    Measured: 48 Hours

  7. Connectivity Analysis (Number of Connection Errors Between devices)

    Failure analysis of the devices/connectivity issues that may occur. This includes the overall number of connectivity errors between pump, sensor and phone device and the types of errors and how they were addressed.

    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 posted20 Apr 2018
  2. Study start28 Feb 2018
  3. Primary completion4 Sep 2018
  4. Study completion4 Sep 2018

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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03504046
Sponsor's protocol ID
G180011
Status last verified
Sep 2018
First submitted
5 Apr 2018
Last updated
5 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Artificial Pancreas App 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 8 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 5 Sep 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 in glucose range 70-180 mg/dL (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 NCT03504046.

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 5 Sep 2018.

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