Glucomen Day Cascade CGM System 21-Day Wear Study (GLUCODAY21)

GlucoMen Day Cascade CGM 21-Day Study

Assessment of 21-day CGM wear period

Study Overview

• Status: Completed
• Conditions: Efficacy of a 21-Day Wear Period for the Cascade CGM
• Intervention / Treatment: Device: Cascade CGM

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Clinical Hospital "Sveti Duh"
• Slovenia
  • Novo Mesto, Slovenia
    • Miremo, d.o.o

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Persons with Type I and Type II Diabetes

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GLUCODAY21; Study subjects for 21-day study	Device: Cascade CGM; 21-days of CGM wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Uniformity	To evaluate the uniformity of the performance of the WaveForm GlucoMen Day Cascade CGM over 21 days.	From 15 to 21 days

Collaborators and Investigators

• Sponsor: WaveForm Technologies Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2020
• Primary Completion (Actual): September 27, 2020
• Study Completion (Actual): November 15, 2020

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PR-19-0037

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes