CGMIS 48-hour Feasibility Study

NCT05562206 | Unknown FDA Device

• 1 other identifier: CIP-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, single arm non-randomized study of 48-hour CGMIS wear duration incorporating two meal-challenge tests to explore the performance of a single insertion combined glucose-sensing insulin delivery cannula.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (2)

• Accuracy

  Sensor accuracy as determined by mean absolute difference (MAD) for reference YSI venous blood glucose values ≤75 mg/dL and mean absolute relative difference (MARD) for reference YSI venous blood glucose values \>75 mg/dL

  First 48 hours

• Accuracy

  • Sensor accuracy in the performance metrics described in the FDA iCGM Special Controls.

  First 48 hours

Secondary Outcomes (4)

• Number of subjects who discontinue delivery of insulin through the device due to unexplained hyperglycemia

  First 48 hours

• Results of tolerability questionnaire

  First 48 hours

• Results of Draize scale

  Firts 48 hours

• Visual Analog Scale (VAS) for site discomfort

  First 48 hours

Study Arms (1)

Study group

EXPERIMENTAL

All subjects using the study device

Device: CGMIS (Continuous Glucose Monitoring Infusion Set)

Interventions

CGMIS (Continuous Glucose Monitoring Infusion Set) DEVICE

An integrated combination CGM/insulin infusion system

Study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes, present for at least 6 months. If there is lack of clarity regarding the type of diabetes, the PI will make the final decision based on medical records.
• Age 18-75
• Currently using a Tandem T-Slim or Medtronic 523/723 or newer series insulin pump to treat their diabetes.
• Hgb A1C between 5.8 and 10%
• Willingness to follow all study procedures and to attend all clinic visits.
• Willingness to sign informed consent and HIPPA documents.

You may not qualify if:

• Need for MRI/CT/Diathermy during study participation
• Current use of Hydroxyurea
• History of chronic kidney disease
• Inability to read pump or CGM display due to reduced visual acuity
• History of unstable ischaemic heart disease or myocardial infarction within the last 3 months.
• History of chronic liver disease
• Active infection such as HIV or hepatitis
• Anemia defined by HCT at least 4 percentage points below lower limit of the reference range
• Dementia, Schizophrenia or other untreated mental illness
• Chronic substance abuse
• Chronic alcohol abuse
• Seizure disorder
• Major surgical operation within 30 days prior to screening
• History of bleeding disorder or treatment with anticoagulants.
• Allergy to acrylate-based skin adhesives

Sponsors & Collaborators

• Pacific Diabetes Technologies: lead

Study Sites (1)

Rainier Clinical Research Center

Renton, Washington, 98057, United States

RECRUITING

Central Study Contacts

Bob Janowski

CONTACT

818-395-6576; bjanowski@pacificdt.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 30, 2022
• Study Start: August 30, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

US (1)