Glucomen Day Cascade CGM System 21-Day Wear Study

NCT ID: NCT05460260

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-12
• Study Completion Date: 2020-11-15

Brief Summary

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

GLUCODAY21

Study subjects for 21-day study

Cascade CGM

Intervention Type: DEVICE

21-days of CGM wear

Interventions

Cascade CGM

21-days of CGM wear

Intervention Type: DEVICE

Eligibility Criteria

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 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

Exclusion Criteria

• • 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
• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

WaveForm Technologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Hospital "Sveti Duh"

Zagreb, , Croatia

Miremo, d.o.o

Novo Mesto, , Slovenia

Countries

Croatia; Slovenia

Other Identifiers

PR-19-0037

Identifier Type: -

Identifier Source: org_study_id