CGMIS 48-hour Feasibility Study

A 48hr Study to Test Feasibility of the Pacific Diabetes Technologies Continuous Glucose Monitor Infusion Set (CGMIS) Sensing Interstitial Glucose Continuously in the Immediate Vicinity of SQ Insulin Delivery in Adults With T1 Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Type1diabetes
• Intervention / Treatment: Device: CGMIS (Continuous Glucose Monitoring Infusion Set)

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bob Janowski; Phone Number: 818-395-6576; Email: bjanowski@pacificdt.com

Study Locations

• United States
  • Washington
    • Renton, Washington, United States, 98057
      • Recruiting
      • Rainier Clinical Research Center
      • Contact: Ronald Brazg, MD; Phone Number: 425-251-1720; Email: rbrazg@rainier-research.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• Ongoing use of an investigational drug or device
• Female of childbearing potential who is pregnant or intending to become pregnant
• Diabetic ketoacidosis or hypoglycemia requiring hospitalization within the last 6 months
• Insulin resistance as defined by insulin requirement of more than 200 units per day
• Use of glucose-lowering medications other than insulin
• Need for uninterrupted treatment with acetaminophen
• Any other physical or mental condition judged by the PI as being exclusionary.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; All subjects using the study device	Device: CGMIS (Continuous Glucose Monitoring Infusion Set); An integrated combination CGM/insulin infusion system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects who discontinue delivery of insulin through the device due to unexplained hyperglycemia	this will be the number of subjects who experience unexplained glycemic excursions requiring a cannula change	First 48 hours
Results of tolerability questionnaire	A tolerability questionnaire will assess level of discomfort (none to severe), and duration.	First 48 hours
Results of Draize scale	Draize scale will be used by study staff to evaluate the presence and severity of erythema and edema at the site of device use after removal.	Firts 48 hours
Visual Analog Scale (VAS) for site discomfort	Subject will place a mark along a 100mm line to denote visually their perceived intensity of discomfort. Results will range from no discomfort to worst possible discomfort.	First 48 hours

Collaborators and Investigators

• Sponsor: Pacific Diabetes Technologies

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CIP-01

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.: No