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Type 1 Diabetes MellitusPhase 1NCT02849288

Bigfoot Biomedical Clinical Research Center (CRC) Trial

A Phase 1 study testing Bigfoot Biomedical Type 1 Diabetes Management System (T1DMS) in people with Type 1 Diabetes Mellitus, run by Bigfoot Biomedical Inc. at 3 sites 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 trial is designed to assess safety and feasibility of the Bigfoot Biomedical Type 1 Diabetes Management System (T1DMS) in up to 50 participants in a closely monitored Clinical Research Center (CRC) environment. Read more about this study

Who is it for?
Ages 7 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Bigfoot Biomedical Type 1 Diabetes Management System (T1DMS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesUnited States
Study dates
Jul 2016to Dec 2016
Phase
Phase 1
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 7 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Insulin dependent type 1 diabetes (T1D) for at least one year
  • Age ≥ 7 years of age
  • Weight ≥ 26 kg
  • HbA1c <10%
  • Total BASAL insulin dose (24 hour cumulative total) that is ≥ 5 units and ≤ 72 units per day
  • Insulin regimen stable on either multiple daily insulin injections (MDI) or insulin infusion pump therapy for ≥ 6 months. Regimen must include basal insulin and the use of a rapid acting analog insulin to cover meals (e.g., Novolog, Humalog or Apidra)
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  • For participants on MDI, basal insulin must be either once daily Lantus (Glargine) or once daily Levemir (Detemir). The once daily basal insulin dose must be administered in the evening or at bedtime
  • Able to engage in at least 60 minutes of moderate exercise if ≥ 12 years of age (e.g., walking or biking) and if ≥ 7 and < 12 years of age moderate activity (e.g., walking or active play)
  • Willing and able to refrain from use of any medication containing acetaminophen during participation in the study (from the time of consent until study exit)
  • Willing and able to use Humalog insulin during the CRC admission
  • Able to speak and read English

Who cannot join

  • Females who are sexually active and able to conceive will be excluded if they are not currently using or agree to continue use for the duration of the study an effective method of contraception as determined by investigator
  • Females who are pregnant or intending to become pregnant during participation in the trial
  • Females who are capable of childbearing must have a negative pregnancy test at the time of the screening visit and the pregnancy test must be repeated at enrollment if it was done > 14 days prior
  • Presence of any condition that in the opinion of the investigator impairs the participant's ability to use the system (e.g.,visual impairment that interferes with ability to read the display)
  • Unable or unwilling to use study devices and follow study procedures including the meal and exercise/ activity challenges in the CRC.
  • A current condition that would prevent the use of a study devices, including blood glucose meter (BGM), continuous glucose monitoring (CGM) or insulin pump (CSII)
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  • Current participation within the last 60 days in another clinical research study that involves an intervention
  • Participation in research studies involving data collection only is not an exclusion (e.g.,T1D Exchange Registry)
  • Anticoagulant therapy other than aspirin
  • Severe hypoglycemia resulting in seizure OR loss of consciousness within 30 days prior to enrollment
  • Diabetic ketoacidosis (DKA) requiring treatment in a healthcare facility within 30 days prior to enrollment
  • Current use (defined as within the last 3 months) of any medication intended to lower glucose other than insulin (e.g., use of Metformin, Liraglutide, would be exclusions)
  • Current use (defined as within the last 3 months) of any medication that according to the dose, frequency, and route of administration may result in hyperglycemia in the investigator's judgment (e.g., current use of oral steroids)
  • Regular use of inhaled or intranasal steroids is permitted
  • Presence of significant renal disease as evidenced by the presence of any of the following:
  • Current dialysis therapy
  • Serum creatinine of ≥ 2.0 mg/dL within 30 days of enrollment
  • For screening purposes, serum creatinine levels will be tested in participants who meet any of the following criteria:
  • A≥10 year history of T1D
  • Are ≥ 45 years of age
  • Presence or history of clinically significant cardiovascular disease (e.g., myocardial infarction, pacemaker, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, atrial or ventricular fibrillation, treatment for arrhythmia, stable or unstable angina, episode of chest pain of cardiac etiology with associated ECG changes or positive stress test/ cardiac catheterization, congestive heart failure, or cerebrovascular event)
  • ECG findings that indicate participation in the planned exercise/ activity session would be contraindicated as determined by trained personnel at the respective clinical center(s)
  • For screening purposes, ECGs must be completed within 30 days of enrollment in participants who meet any of the following criteria:
  • A ≥ 10 year history of T1D and ≥ 20 years of age
  • Are ≥ 45 years of age
  • History of adrenal insufficiency
  • A diagnosis of gastroparesis or impaired gastric motility that required pharmacological or surgical treatment
  • Celiac Disease (CD) diagnosed < 12 months ago or CD that is currently inadequately treated as determined by the investigator
  • Current alcohol abuse or eating disorder as determined by the investigator
  • Use or abuse of controlled substances without a prescription in the 6 months prior to enrollment
  • History of hemoglobinopathy, sickle cell disease, or blood dyscrasia; blood transfusion within 3 months of enrollment
  • Hematocrit that is above or below the normal reference range of the lab used within 14 days of enrollment
  • Presence or history of any medical or psychiatric condition, or the use of any medication or therapy, that in the opinion of the investigator may be a contraindication to participation in the study
  • Unstable hypertension, thyroid disease, or depression as evidenced by an adjustment in therapy for the condition within the last 2 months, or as determined by investigator

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado, 80045

  • William Sansum Diabetes Research Institute

    Santa Barbara, California, 93111

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

The trial is designed to assess safety and feasibility of the Bigfoot Biomedical Type 1 Diabetes Management System (T1DMS) in up to 50 participants in a closely monitored Clinical Research Center (CRC) environment.

Being tested
Bigfoot Biomedical Type 1 Diabetes Management System (T1DMS)
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.

  • Bigfoot Biomedical Type 1 Diabetes Management System (T1DMS)Device

    Also called T1DMS

    Automated Insulin Delivery System

Study groups in NCT02849288
Study groupRoleWhat they receive
InterventionExperimentalUse of the Investigational Bigfoot Type 1 Diabetes Management System (T1DMS)
Receives: Device: Bigfoot Biomedical Type 1 Diabetes Management System (T1DMS)

What is being measured

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

  1. Evaluate performance of the algorithm/ system commanded delivery of insulin in response to glucose trends from the CGM. in an effort to avoid hypoglycemia and hyperglycemia.

    Annotated graphs will be used to assess this outcome.

    Measured: Data will be evaluated upon completion of an individual participant (data collected over approximately 48 hours of use), upon completion of each age cohort, and upon completion of the trial

  2. Assessment of safety outcomes and serious adverse events and device related adverse effects.

    Measured: Data will be evaluated upon completion of an individual participant (data collected over approximately 48 hours of use), upon completion of each age cohort, and upon completion of the trial

Secondary outcomes (2)

  1. Measures of glycemic control

    Additional measures include but are not limited to, mean glucose (arithmetic and geometric), Glucose variability as assessed by coefficient of variation and standard deviation (arithmetic and geometric). Percentage of time spent below or above glucose threshold levels.

    Measured: Data will be evaluated upon completion of an individual participant (data collected over approximately 48 hours of use), upon completion of each age cohort, and upon completion of the trial

  2. System functionality as evidenced by the availability of CGM data

    Includes but is not limited to the percentage of time CGM values were available for individual participants and for all participants pooled.

    Measured: Data will be evaluated upon completion of an individual participant (data collected over approximately 48 hours of use), upon completion of each age cohort, and upon completion of the trial

Timeline

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

  1. First posted29 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02849288
Sponsor's protocol ID
TST-10025
Status last verified
Dec 2016
First submitted
20 Jul 2016
Last updated
19 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bigfoot Biomedical Type 1 Diabetes Management System (T1DMS) in people with Type 1 Diabetes Mellitus, run by Bigfoot Biomedical Inc. at 3 sites 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 11 inclusion and 34 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 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Evaluate performance of the algorithm/ system commanded delivery of insulin in response to glucose trends from the CGM. in an effort to avoid hypoglycemia and hyperglycemia. (time frame: Data will be evaluated upon completion of an individual participant (data collected over approximately 48 hours of use), upon completion of each age cohort, and upon completion of the trial). The study lists 2 primary outcomes in all. 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 NCT02849288.

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 19 Dec 2016.

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