Glucomen Day Cascade CGM System 21-Day Wear Study

NCT05460260 | Completed FDA Device

• 1 other identifier: PR-19-0037
• Study Type: observational
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief Summary

Assessment of 21-day CGM wear period

Conditions

Efficacy of a 21-Day Wear Period for the Cascade CGM

Outcome Measures

Primary Outcomes (1)

• 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.

  21 Days

Secondary Outcomes (1)

• Evaluation of Uniformity

  From 15 to 21 days

Study Arms (1)

GLUCODAY21

Study subjects for 21-day study

Device: Cascade CGM

Interventions

Cascade CGM DEVICE

21-days of CGM wear

GLUCODAY21

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Persons with Type I and Type II Diabetes

You may qualify if:

• Diagnosis of type 1 or type 2 (on insulin therapy) diabetes mellitus for at least 6 months
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• WaveForm Technologies Inc.: lead

Study Sites (2)

Clinical Hospital "Sveti Duh"

Zagreb, 10000, Croatia

Location

Miremo, d.o.o

Novo Mesto, Slovenia

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: September 12, 2020
• Primary Completion: September 27, 2020
• Study Completion: November 15, 2020
• Last Updated: July 15, 2022

Record last verified: 2021-10

Locations

CR (1); SL (1)