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Cascade CGM 15-day Performance Assessment (CASPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099043
Recruitment Status : Completed
First Posted : September 23, 2019
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
WaveForm Technologies Inc.

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

Condition or disease Intervention/treatment Phase
Continuous Glucose Monitoring Device: Cascade Continuous Glucose Monitoring System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cascade Continuous Glucose Monitor 15-day Performance Assessment
Actual Study Start Date : September 28, 2019
Actual Primary Completion Date : October 13, 2019
Actual Study Completion Date : October 13, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Continuous Monitoring
Single Arm, Randomized
Device: Cascade Continuous Glucose Monitoring System
Continuous Glucose Monitoring for 15 days




Primary Outcome Measures :
  1. 15-day Continuous Glucose Monitoring [ Time Frame: Fifteen days ]
    Fifteen days of sensor wear with the Cascade CGM Smart Device App



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099043


Locations
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Slovenia
Splošna bolnišnica Celje
Celje, Slovenia
Sponsors and Collaborators
WaveForm Technologies Inc.
Investigators
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Principal Investigator: Maja Navodnik Peložnik, MD Splošna bolnišnica Celje
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Responsible Party: WaveForm Technologies Inc.
ClinicalTrials.gov Identifier: NCT04099043    
Other Study ID Numbers: PR-19-0032
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No