CGMIS 48-hour Feasibility Study
Primary Purpose
Type1diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CGMIS (Continuous Glucose Monitoring Infusion Set)
Sponsored by
About this trial
This is an interventional other trial for Type1diabetes
Eligibility Criteria
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.
Sites / Locations
- Rainier Clinical Research CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
All subjects using the study device
Outcomes
Primary Outcome Measures
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
Accuracy
• Sensor accuracy in the performance metrics described in the FDA iCGM Special Controls.
Secondary Outcome Measures
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
Results of tolerability questionnaire
A tolerability questionnaire will assess level of discomfort (none to severe), and duration.
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.
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.
Full Information
NCT ID
NCT05562206
First Posted
September 26, 2022
Last Updated
September 28, 2022
Sponsor
Pacific Diabetes Technologies
1. Study Identification
Unique Protocol Identification Number
NCT05562206
Brief Title
CGMIS 48-hour Feasibility Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pacific Diabetes Technologies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
All subjects using the study device
Intervention Type
Device
Intervention Name(s)
CGMIS (Continuous Glucose Monitoring Infusion Set)
Intervention Description
An integrated combination CGM/insulin infusion system
Primary Outcome Measure Information:
Title
Accuracy
Description
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
Time Frame
First 48 hours
Title
Accuracy
Description
• Sensor accuracy in the performance metrics described in the FDA iCGM Special Controls.
Time Frame
First 48 hours
Secondary Outcome Measure Information:
Title
Number of subjects who discontinue delivery of insulin through the device due to unexplained hyperglycemia
Description
this will be the number of subjects who experience unexplained glycemic excursions requiring a cannula change
Time Frame
First 48 hours
Title
Results of tolerability questionnaire
Description
A tolerability questionnaire will assess level of discomfort (none to severe), and duration.
Time Frame
First 48 hours
Title
Results of Draize scale
Description
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.
Time Frame
Firts 48 hours
Title
Visual Analog Scale (VAS) for site discomfort
Description
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.
Time Frame
First 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bob Janowski
Phone
818-395-6576
Email
bjanowski@pacificdt.com
Facility Information:
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Brazg, MD
Phone
425-251-1720
Email
rbrazg@rainier-research.com
12. IPD Sharing Statement
Learn more about this trial
CGMIS 48-hour Feasibility Study
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