Clinical trial NCT05562206: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Pacific Diabetes Technologies
Sponsor class: INDUSTRY
First posted: 2022-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Accuracy
timeFrame: First 48 hours
measure: Accuracy
timeFrame: First 48 hours
Secondary outcomes:
measure: Number of subjects who discontinue delivery of insulin through the device due to unexplained hyperglycemia
timeFrame: First 48 hours
measure: Results of tolerability questionnaire
timeFrame: First 48 hours
measure: Results of Draize scale
timeFrame: Firts 48 hours
measure: Visual Analog Scale (VAS) for site discomfort
timeFrame: First 48 hours
Other outcomes:
Locations:
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
References: