Recruiting

Observational Study

Sponsor:

Pacific Diabetes Technologies

Code:

NCT05562206

Conditions

Type1diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

CGMIS (Continuous Glucose Monitoring Infusion Set)

Study Details

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.

Conditions

Type1diabetes

Study ID

NCT05562206

Start date

Aug 30, 2022

Status verified date

Sep, 2022

Completion date

Nov, 2022

Anticipated

Primary completion date

Oct, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Study group

All subjects using the study device

Interventions

CGMIS (Continuous Glucose Monitoring Infusion Set)

An integrated combination CGM/insulin infusion system

Primary outcome measure

  • Accuracy [ Time Frame: First 48 hours ]
  • Accuracy [ Time Frame: First 48 hours ]

Central Contacts and Locations

Central contacts

Bob Janowski

818-395-6576bjanowski@pacificdt.com

Locations

Rainier Clinical Research Center

Recruiting

Renton, Washington, United States, 98057

Contacts

Ronald Brazg, MD

425-251-1720rbrazg@rainier-research.com

More Information

Sponsor

Pacific Diabetes Technologies

Last update posted

Sep 30, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pacific Diabetes Technologies on 2022-09-30.