CGMIS 48-hour Feasibility Study

Study Overview
=================
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.

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

Conditions
-----------------
Type1diabetes

Intervention / Treatment
-----------------
* Device: CGMIS (Continuous Glucose Monitoring Infusion Set)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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 |