Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-08-30
2022-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Study group
All subjects using the study device
CGMIS (Continuous Glucose Monitoring Infusion Set)
An integrated combination CGM/insulin infusion system
Interventions
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CGMIS (Continuous Glucose Monitoring Infusion Set)
An integrated combination CGM/insulin infusion system
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Pacific Diabetes Technologies
INDUSTRY
Responsible Party
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Locations
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Rainier Clinical Research Center
Renton, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Ronald Brazg, MD
Role: primary
Other Identifiers
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CIP-01
Identifier Type: -
Identifier Source: org_study_id