Type1diabetes
Conditions
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.
Interventions
DEVICECGMIS (Continuous Glucose Monitoring Infusion Set)
An integrated combination CGM/insulin infusion system
Sponsors
Pacific Diabetes Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy | First 48 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects who discontinue delivery of insulin through the device due to unexplained hyperglycemia | First 48 hours | this will be the number of subjects who experience unexplained glycemic excursions requiring a cannula change |
| Results of tolerability questionnaire | First 48 hours | A tolerability questionnaire will assess level of discomfort (none to severe), and duration. |
| Results of Draize scale | Firts 48 hours | 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 | First 48 hours | 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. |
Countries
United States
Contacts
Primary ContactBob Janowski
Outcome results
None listed