Cascade CGM 15-day Performance Assessment (CASPA)

Cascade Continuous Glucose Monitor 15-day Performance Assessment

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

Study Overview

• Status: Completed
• Conditions: Continuous Glucose Monitoring
• Intervention / Treatment: Device: Cascade Continuous Glucose Monitoring System

Detailed Description

To assess a 15-day wear period for the Cascade CGM. This study includes ten subjects who will interface with the system and take finger stick BGM glucose values for calibration. The wear period includes four in-clinic days frequent blood draws and eleven at home days at a single testing site.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Celje, Slovenia
    • Splosna bolnisnica Celje

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Signed informed consent form

  • Diagnosis of type 1 or type 2 (on insulin therapy) diabetes mellitus for at least 6 months
  • 18 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.

Exclusion Criteria:

• • 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
  • Other medical conditions that would pose safety concerns, interfere with study conduct or seriously compromise study integrity (reason for exclusion will be clearly documented by investigator or designee)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Monitoring; Single Arm, Randomized	Device: Cascade Continuous Glucose Monitoring System; Continuous Glucose Monitoring for 15 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
15-day Continuous Glucose Monitoring	Fifteen days of sensor wear with the Cascade CGM Smart Device App	Fifteen days

Collaborators and Investigators

• Sponsor: WaveForm Technologies Inc.
• Investigators: Principal Investigator: Maja Navodnik Peložnik, MD, Splosna bolnisnica Celje

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2019
• Primary Completion (Actual): October 13, 2019
• Study Completion (Actual): October 13, 2019

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PR-19-0032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No