Continuous Glucose MonitoringCUSPNCT04397965
Cascade Continuous Glucose Monitor (CGM) 15-Day US Performance Assessment
A study testing Cascade Continuous Glucose Monitor in people with Continuous Glucose Monitoring, run by WaveForm Technologies Inc..
Trial summary
To assess a 15-day wear period of the Cascade Continuous Glucose Monitoring (CGM) System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Glucose Monitoring
- What is being tested?
- Cascade Continuous Glucose Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cascade CGM 15-Day US Performance Assessment
To assess a 15-day wear period of the Cascade Continuous Glucose Monitoring (CGM) System
Read the 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.
- Conditions
- Continuous Glucose Monitoring
- Being tested
- Cascade Continuous Glucose Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cascade Continuous Glucose MonitorDevice
Also called Cascade CGM
Continuous Glucose Monitoring
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Continuous Monitoring | Experimental | Intervention: Device: Cascade Continuous Glucose Monitoring System Receives: Device: Cascade Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Use
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.
Measured: 15 days
Secondary outcomes (1)
Performance
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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study startDec 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Glucose MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WaveForm Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397965
- Sponsor's protocol ID
- EXT-1040
- Acronym
- CUSP
- Status last verified
- May 2020
- First submitted
- 2 Apr 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cascade CGM 15-Day US Performance Assessment
- ClinicalTrials.gov ID
- NCT04397965
- Acronym / sponsor ID
- CUSP / EXT-1040
- Conditions
- Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- WaveForm Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess a 15-day wear period of the Cascade Continuous Glucose Monitoring (CGM) System
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Continuous Monitoring | Experimental | Device: Cascade Continuous Glucose MonitorIntervention: Device: Cascade Continuous Glucose Monitoring System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cascade Continuous Glucose MonitorAlso: Cascade CGMContinuous Glucose Monitoring | Device | Experimental: Continuous Monitoring |
Primary outcome
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.
1 secondary outcome
Performance
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Cascade Continuous Glucose Monitor in people with Continuous Glucose Monitoring, run by WaveForm Technologies Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mihailo V. Rebec, PhD (503-855-5377, mrebec@agamatrix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Use (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.