Continuous Glucose MonitoringCASPANCT04099043
Cascade CGM 15-day Performance Assessment
A study testing Cascade Continuous Glucose Monitoring System in people with Continuous Glucose Monitoring, run by WaveForm Technologies Inc. at 1 site in Slovenia.
Trial summary
To validate the feasibility of a 15-day wear period of the Cascade 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 Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSlovenia
- Study dates
- 28 Sep 2019to 13 Oct 2019
- 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
- • 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.
Who cannot join
- • 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cascade Continuous Glucose Monitor 15-day Performance Assessment
To validate the feasibility of a 15-day wear period of the Cascade CGM system
Read the 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.
- Conditions
- Continuous Glucose Monitoring
- Being tested
- Cascade Continuous Glucose Monitoring System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cascade Continuous Glucose Monitoring SystemDevice
Continuous Glucose Monitoring for 15 days
| Study group | Role | What they receive |
|---|---|---|
| Continuous Monitoring | Experimental | Single Arm, Randomized Receives: Device: Cascade Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
15-day Continuous Glucose Monitoring
Fifteen days of sensor wear with the Cascade CGM Smart Device App
Measured: Fifteen days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start28 Sep 2019
- Primary completion13 Oct 2019
- Study completion13 Oct 2019
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- WaveForm Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maja Navodnik Peložnik, MD, Principal investigator, Splošna bolnišnica Celje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099043
- Sponsor's protocol ID
- PR-19-0032
- Acronym
- CASPA
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cascade Continuous Glucose Monitor 15-day Performance Assessment
- ClinicalTrials.gov ID
- NCT04099043
- Acronym / sponsor ID
- CASPA / PR-19-0032
- Conditions
- Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- WaveForm Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2019 (actual)
- Primary completion
- 13 Oct 2019 (actual)
- Study completion
- 13 Oct 2019 (actual)
- First posted
- 23 Sep 2019 (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 validate the feasibility of a 15-day wear period of the Cascade CGM 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Monitoring | Experimental | Device: Cascade Continuous Glucose Monitoring SystemSingle Arm, Randomized |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Signed informed consent form
Key exclusion criteria (16 listed)
- • Known allergy to medical grade adhesives
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 Monitoring SystemContinuous Glucose Monitoring for 15 days | Device | Continuous Monitoring |
Primary outcome
15-day Continuous Glucose Monitoring
Time frame: Fifteen days
Fifteen days of sensor wear with the Cascade CGM Smart Device App
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 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.
Maja Navodnik Peložnik, MD principal investigator
Splošna bolnišnica Celje
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cascade Continuous Glucose Monitoring System in people with Continuous Glucose Monitoring, run by WaveForm Technologies Inc. at 1 site in Slovenia.
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 7 inclusion and 16 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: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
15-day Continuous Glucose Monitoring (time frame: Fifteen 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 6 Apr 2020; AzTrials last refreshed its copy on 28 Oct 2026.