Trial Search Results

Bigfoot Biomedical Clinical Research Center (CRC) Trial

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Bigfoot Biomedical Inc.

Collaborator: Profil Institute for Clinical Research, Inc.

Stanford Investigator(s):

Intervention(s):

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

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   1. Insulin dependent type 1 diabetes (T1D) for at least one year

   2. Age ≥ 7 years of age

   3. Weight ≥ 26 kg

   4. HbA1c <10%

   5. Total BASAL insulin dose (24 hour cumulative total) that is ≥ 5 units and ≤ 72 units
   per day

   6. 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)

      - 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

   7. 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)

   8. 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)

   9. Willing and able to use Humalog insulin during the CRC admission

10. Able to speak and read English

Exclusion Criteria:

   1. 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

   2. 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

   3. 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)

   4. Unable or unwilling to use study devices and follow study procedures including the
   meal and exercise/ activity challenges in the CRC.

   5. 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)

   6. 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)

   7. Anticoagulant therapy other than aspirin

   8. Severe hypoglycemia resulting in seizure OR loss of consciousness within 30 days prior
   to enrollment

   9. Diabetic ketoacidosis (DKA) requiring treatment in a healthcare facility within 30
   days prior to enrollment

10. 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)

11. 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

12. 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

13. 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)

14. 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

15. History of adrenal insufficiency

16. A diagnosis of gastroparesis or impaired gastric motility that required
   pharmacological or surgical treatment

17. Celiac Disease (CD) diagnosed < 12 months ago or CD that is currently inadequately
   treated as determined by the investigator

18. Current alcohol abuse or eating disorder as determined by the investigator

19. Use or abuse of controlled substances without a prescription in the 6 months prior to
   enrollment

20. History of hemoglobinopathy, sickle cell disease, or blood dyscrasia; blood
   transfusion within 3 months of enrollment

21. Hematocrit that is above or below the normal reference range of the lab used within 14
   days of enrollment

22. 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

23. 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

Ages Eligible for Study

7 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Eliana Frank
650-736-6642
Recruiting