A Pilot Study of the Feasibility and Accuracy of the TrueVie CGM System - A Non-Significant Risk Study

NCT05348928 | Completed FDA Device

• 1 other identifier: NPI031-CEP-001F
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the investigation is to obtain sufficient preliminary information about the performance of the TrueVie Continuous Glucose Monitoring (CGM) device to identify any need for any design modifications.

Conditions

Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events

  safety is assessed by adverse events

  15 days

• Incidence of Treatment-Emergent Adverse Device Events

  safety is assessed by adverse device effects

  15 days

• Insertion Site Intensity of any Erythema on a Likert scale

  tolerability by intensity of erythema at the insertion site

  15 days

• Insertion Site Erythema Size estimated from Lengths of Major and Minor Axis

  tolerability by size of erythema at the insertion site

  15 days

• Edema by Maximal Height from Surrounding Skin Surface

  tolerability by edema at insertion site

  15 days

Secondary Outcomes (1)

• Sensor Accuracy by Mean Absolute Glucose Concentration Difference from Reference

  15 days

Study Arms (2)

With oral ascorbic acid

1 g ascorbic acid orally

Device: Continuous glucose monitoring device; Other: Laboratory plasma glucose concentration determination

Without oral ascorbic acid

No oral ascorbic acid is taken

Device: Continuous glucose monitoring device; Other: Laboratory plasma glucose concentration determination

Interventions

Continuous glucose monitoring device DEVICE

Continuous glucose monitoring device

With oral ascorbic acid; Without oral ascorbic acid

Laboratory plasma glucose concentration determination OTHER

Laboratory plasma glucose concentration determination

With oral ascorbic acid; Without oral ascorbic acid

Eligibility Criteria

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

Study Population

Patients with type 1 diabetes

You may qualify if:

• Type 1 diabetes mellitus 2. Must be and have been in stable treatment regimen for at least 3 months with a multiple daily insulin dosing regimens or Continuous Subcutaneous Insulin Infusion (CSII), irrespective of delivery device(s).
• \. Must have normal exercise tolerance.

You may not qualify if:

• Skin adhesive tolerance issues in the area of sensor placement
• HbA1c \> 9%.
• Insulin meal dosing based on fixed dose regimens.
• Absence of established corrective factor for high glucose.
• Hematocrit below 10% under the lower limit of the normal range.
• Body mass index \< 20 kg/m2.
• Inadequate intravenous access on arms.
• Absence of moderate exercise tolerance per history
• Pregnancy, planned pregnancy within the study period, or unwillingness to use reliable contraception during the study period.
• Planned MRI, CT scan or diathermic procedure for the duration of the study.
• Any medical history of malignant melanoma or breast cancer.
• Medical history of any other cancers within the last five years except adequately treated basal cell or squamous carcinoma of the skin, or cervical carcinoma in-situ.
• History of alcohol or drug abuse within the last year.
• Any condition that in the opinion of the investigator may interfere successful completion of study procedures.
• Participation in other clinical trials involving receipt of investigational drug that cannot be disclosed within the last 30 days.

Sponsors & Collaborators

• Sinocare Meditech Inc.: lead
• Integrated Medical Development: collaborator

Study Sites (1)

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Poul Strange, MD, PhD

  Integrated Medical Development

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 27, 2022
• Study Start: May 4, 2022
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)