Efficacy of a 21-Day Wear Period for the Cascade CGMGLUCODAY21NCT05460260
Glucomen Day Cascade CGM System 21-Day Wear Study
An observational study of Efficacy of a 21-Day Wear Period for the Cascade CGM, run by WaveForm Technologies Inc. at 2 sites in 2 countries.
Trial summary
Assessment of 21-day CGM wear period Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Efficacy of a 21-Day Wear Period for the Cascade CGM
- What is being tested?
- Cascade CGM
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Sep 2020to 15 Nov 2020
- Phase
- Observational
- 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
Study population: Persons with Type I and Type II Diabetes
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 on a CGM for at least three months
- Be 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.
- Sign informed consent form
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
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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
- Pregnancy 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
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: GlucoMen Day Cascade CGM 21-Day Study
Assessment of 21-day CGM wear period
Read the detailed description
This single-site study will include 10 subjects who will wear two CGMs for 21 days. On day 1, 5, 10, 15, and 21 subjects will be in-clinic for 12 hrs of testing with YSI blood glucose measurements taken every 15 minutes.
- Being tested
- Cascade CGM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cascade CGMDevice
21-days of CGM wear
| Study group | Role | What they receive |
|---|---|---|
| GLUCODAY21 | Study subjects for 21-day study Receives: Device: Cascade CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
21-Day CGM Functionality The secondary objective is: -To evaluate the uniformity of the performance of the WaveForm GlucoMmen Day Cascade CGM over 21 days.
To evaluate the feasibility of a 21-day wear CGM system.
The secondary objective is:
-To evaluate the uniformity of the performance of the WaveForm GlucoMmen Day Cascade CGM over 21 days.
To evaluate the feasibility of a 21-day wear CGM system.
Measured: 21 Days
Secondary outcomes (1)
Evaluation of Uniformity
To evaluate the uniformity of the performance of the WaveForm GlucoMen Day Cascade CGM over 21 days.
Measured: From 15 to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start12 Sep 2020
- Primary completion27 Sep 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy of a 21-Day Wear Period for the Cascade CGMStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- WaveForm Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460260
- Sponsor's protocol ID
- PR-19-0037
- Acronym
- GLUCODAY21
- Status last verified
- Oct 2021
- First submitted
- 12 Jul 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlucoMen Day Cascade CGM 21-Day Study
- ClinicalTrials.gov ID
- NCT05460260
- Acronym / sponsor ID
- GLUCODAY21 / PR-19-0037
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- WaveForm Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 27 Sep 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 15 Jul 2022 (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.
Assessment of 21-day CGM wear period
Detailed description
This single-site study will include 10 subjects who will wear two CGMs for 21 days. On day 1, 5, 10, 15, and 21 subjects will be in-clinic for 12 hrs of testing with YSI blood glucose measurements taken every 15 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLUCODAY21 | – | Device: Cascade CGMStudy subjects for 21-day study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with Type I and Type II Diabetes
Key inclusion criteria (7 listed)
- • Diagnosis of type 1 or type 2 (on insulin therapy) diabetes mellitus for at least 6 months
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 CGM21-days of CGM wear | Device | GLUCODAY21 |
Primary outcome
21-Day CGM Functionality The secondary objective is: -To evaluate the uniformity of the performance of the WaveForm GlucoMmen Day Cascade CGM over 21 days.
Time frame: 21 Days
To evaluate the feasibility of a 21-day wear CGM system. The secondary objective is: -To evaluate the uniformity of the performance of the WaveForm GlucoMmen Day Cascade CGM over 21 days. To evaluate the feasibility of a 21-day wear CGM system.
1 secondary outcome
Evaluation of Uniformity
Time frame: From 15 to 21 days
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 15 Jul 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Efficacy of a 21-Day Wear Period for the Cascade CGM, run by WaveForm Technologies Inc. at 2 sites in 2 countries.
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 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia, 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?
21-Day CGM Functionality The secondary objective is: -To evaluate the uniformity of the performance of the WaveForm GlucoMmen Day Cascade CGM over 21 days. (time frame: 21 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 15 Jul 2022.