Cascade Continuous Glucose Monitor (CGM) 15-Day US Performance Assessment

NCT04397965 | Unknown FDA Device

• 1 other identifier: EXT-1040
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess a 15-day wear period of the Cascade Continuous Glucose Monitoring (CGM) System

Conditions

Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• Feasibility of Use

  Validate the feasibility of a 15-day wear period of the Cascade CGM. The primary endpoint is an 80% sensor survival rate over a 15-day wear period, which includes four in-clinic days and eleven at-home days.

  15 days

Secondary Outcomes (1)

• Performance

  15 days

Study Arms (1)

Experimental: Continuous Monitoring

EXPERIMENTAL

Intervention: Device: Cascade Continuous Glucose Monitoring System

Device: Cascade Continuous Glucose Monitor

Interventions

Cascade Continuous Glucose Monitor DEVICE

Continuous Glucose Monitoring

Also known as: Cascade CGM

Experimental: Continuous Monitoring

Eligibility Criteria

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

You may qualify if:

• Diagnosis of type 1 or type 2 (on insulin therapy) diabetes mellitus for at least 6 months
• years of age or older
• Currently self-monitoring capillary blood glucose (on average at least three times per day or more) or using a CGM for at least three months -Willing to follow all study procedures, including attending all clinic visits (including in- clinic sessions during which a venous line will be inserted for blood sampling), wearing a CGM sensor(s) for fifteen days, performing fingertip glucose tests for self-monitoring, and keeping a diary of activities.
• Be willing to wear 2 investigational CGM devices.

You may not qualify if:

• Known allergy to medical grade adhesives
• Magnetic Resonance Imaging (MRI) scheduled during fifteen-day CGM sensor wear period
• Persons with type 2 diabetes using diet and exercise only for diabetes management
• Used an investigational drug within 30 days prior to study entry
• Hematocrit \< 35% for females and \<40% for males (obtained during screening)
• Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal
• Symptomatic coronary artery disease with a history of angina, or history of a myocardial infarction or coronary intervention (e.g., percutaneous transluminal coronary angioplasty (PTCA), stent placement), or coronary artery bypass graft (CABG) within the past six months
• Diagnosis of the following diabetic autonomic neuropathies: orthostatic hypotension, heart rate anomalies, gastroparesis
• Cerebrovascular incident within the past six months
• History or presence of eczema, psoriasis, atopic or contact dermatitis
• Subject must not be pregnant at the start of the study.
• Current use or within one-week exposure to topical medications at the proposed insertion sites
• Seizure disorder (epilepsy)
• Malignancy within the past five years, except basal cell or squamous cell skin cancers
• Major surgical operation within 30 days prior to screening

Sponsors & Collaborators

• WaveForm Technologies Inc.: lead

Central Study Contacts

Mihailo V. Rebec, PhD

CONTACT

503-855-5377; mrebec@agamatrix.com

Ellen M Anderson, MPH

CONTACT

503-855-5377; eanderson@agamatrix.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: May 21, 2020
• Study Start: December 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: October 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share