Clinical trial NCT05460260: Glucomen Day Cascade CGM System 21-Day Wear Study
Official title: GlucoMen Day Cascade CGM 21-Day Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Efficacy of a 21-Day Wear Period for the Cascade CGM
Lead sponsor: WaveForm Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Persons with Type I and Type II Diabetes

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.

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)

Primary outcomes:
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.
timeFrame: 21 Days
Secondary outcomes:
measure: Evaluation of Uniformity
timeFrame: From 15 to 21 days
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital "Sveti Duh"
city: Novo Mesto
country: Slovenia
facility: Miremo, d.o.o
Study officials:
References: