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

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: NCT04397965
Recruitment Status : Unknown
Verified May 2020 by WaveForm Technologies Inc..
Recruitment status was:  Not yet recruiting
First Posted : May 21, 2020
Last Update Posted : October 12, 2020
Information provided by (Responsible Party):
WaveForm Technologies Inc.

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

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

Detailed Description:
To assess a 15-day wear period for the Cascade CGM. The study wear period includes four in-clinic days in which frequent blood draws and Yellow Springs Instrument (YSI) glucose measurements will be performed. Participants will be blinded to CGM glucose values during the study. A retrospective performance assessment will be conducted following the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Cascade CGM 15-Day US Performance Assessment
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Experimental: Continuous Monitoring
Intervention: Device: Cascade Continuous Glucose Monitoring System
Device: Cascade Continuous Glucose Monitor
Continuous Glucose Monitoring
Other Name: Cascade CGM

Primary Outcome Measures :
  1. Feasibility of Use [ Time Frame: 15 days ]
    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.

Secondary Outcome Measures :
  1. Performance [ Time Frame: 15 days ]
    Accuracy performance compared to YSI readings. The secondary endpoints are: to achieve <15% Mean Average Relative Difference (MARD) and <20mg/dL Mean Average Difference (MAD) compared to YSI readings during the four in-clinic days and to assess Blood Glucose Meter (BGM) fingerstick calibration success.

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

Inclusion Criteria:

  • 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 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.

Exclusion Criteria:

  1. Known allergy to medical grade adhesives
  2. Magnetic Resonance Imaging (MRI) scheduled during fifteen-day CGM sensor wear period
  3. Persons with type 2 diabetes using diet and exercise only for diabetes management
  4. Used an investigational drug within 30 days prior to study entry
  5. Hematocrit < 35% for females and <40% for males (obtained during screening)
  6. Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal
  7. 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
  8. Diagnosis of the following diabetic autonomic neuropathies: orthostatic hypotension, heart rate anomalies, gastroparesis
  9. Cerebrovascular incident within the past six months
  10. History or presence of eczema, psoriasis, atopic or contact dermatitis
  11. Subject must not be pregnant at the start of the study.
  12. Current use or within one-week exposure to topical medications at the proposed insertion sites
  13. Seizure disorder (epilepsy)
  14. Malignancy within the past five years, except basal cell or squamous cell skin cancers
  15. Major surgical operation within 30 days prior to screening
  16. 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)
  17. Subject has experienced severe hypoglycemia or severe hyperglycemia in the last six months. Severe hypoglycemia is defined as having low blood glucose levels that requires assistance from another person to treat. Severe hypoglycemia is classed as a diabetic emergency. Severe hyperglycemia is defined as a blood ketone level >1.6 millimolar (mM).

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): NCT04397965

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Contact: Mihailo V. Rebec, PhD 503-855-5377 mrebec@agamatrix.com
Contact: Ellen M Anderson, MPH 503-855-5377 eanderson@agamatrix.com

Sponsors and Collaborators
WaveForm Technologies Inc.
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Responsible Party: WaveForm Technologies Inc.
ClinicalTrials.gov Identifier: NCT04397965    
Other Study ID Numbers: EXT-1040
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: May 2020
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes