Bigfoot Biomedical Clinical Research Center (CRC) Trial

NCT02849288 | Completed Phase 1

• 1 other identifier: TST-10025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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.

  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

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

  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)

• Measures of glycemic control

  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

• System functionality as evidenced by the availability of CGM data

  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

Study Arms (1)

Intervention

EXPERIMENTAL

Use of the Investigational Bigfoot Type 1 Diabetes Management System (T1DMS)

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

Interventions

Bigfoot Biomedical Type 1 Diabetes Management System (T1DMS) DEVICE

Automated Insulin Delivery System

Also known as: T1DMS

Intervention

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)
• Current participation within the last 60 days in another clinical research study that involves an intervention
• 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 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

Sponsors & Collaborators

• Bigfoot Biomedical Inc.: lead
• Jaeb Center for Health Research: collaborator
• Profil Institute for Clinical Research, Inc.: collaborator

Study Sites (3)

William Sansum Diabetes Research Institute

Santa Barbara, California, 93111, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 29, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 19, 2016

Record last verified: 2016-12

Locations

US (3)