Cascade CGM 15-day Performance Assessment

NCT04099043 | Completed

• 1 other identifier: PR-19-0032
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To validate the feasibility of a 15-day wear period of the Cascade CGM system

Conditions

Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• 15-day Continuous Glucose Monitoring

  Fifteen days of sensor wear with the Cascade CGM Smart Device App

  Fifteen days

Study Arms (1)

Continuous Monitoring

EXPERIMENTAL

Single Arm, Randomized

Device: Cascade Continuous Glucose Monitoring System

Interventions

Cascade Continuous Glucose Monitoring System DEVICE

Continuous Glucose Monitoring for 15 days

Continuous Monitoring

Eligibility Criteria

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

You may qualify if:

• Signed informed consent form
• 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 on a CGM for at least three months
• Willing to have blood glucose levels manipulated into high and low glucose levels during in clinic days if deemed appropriate per the protocol based on insulin use.
• Willing to follow all study procedures, including attending all clinic visits during which a venous line will be inserted for blood sampling, wearing CGM sensors for entire study, performing fingertip glucose tests for self-monitoring and calibration, and keeping a diary of activities.
• Be willing to wear two investigational CGM devices.

You may not qualify if:

• Known allergy to medical grade adhesives
• Magnetic Resonance Imaging (MRI) scheduled during 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 \< 32% (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 month
• History or presence of eczema, psoriasis, atopic or contact dermatitis
• Subject is 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

Study Sites (1)

Splošna bolnišnica Celje

Celje, Slovenia

Location

Study Officials

• Maja Navodnik Peložnik, MD

  Splošna bolnišnica Celje

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: September 28, 2019
• Primary Completion: October 13, 2019
• Study Completion: October 13, 2019
• Last Updated: April 6, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)