- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04397965
Cascade Continuous Glucose Monitor (CGM) 15-Day US Performance Assessment (CUSP)
October 8, 2020 updated by: WaveForm Technologies Inc.
Cascade CGM 15-Day US Performance Assessment
To assess a 15-day wear period of the Cascade Continuous Glucose Monitoring (CGM) System
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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:
- 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
- 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)
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DEVICE_FEASIBILITY
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental: Continuous Monitoring
Intervention: Device: Cascade Continuous Glucose Monitoring System
|
Continuous Glucose Monitoring
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 1, 2020
Primary Completion (ANTICIPATED)
April 1, 2021
Study Completion (ANTICIPATED)
May 1, 2021
Study Registration Dates
First Submitted
April 2, 2020
First Submitted That Met QC Criteria
May 18, 2020
First Posted (ACTUAL)
May 21, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 12, 2020
Last Update Submitted That Met QC Criteria
October 8, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- EXT-1040
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
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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