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CGMIS 48-hour Feasibility Study | Clinical Trials | Clareo Health

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CGMIS 48-hour Feasibility Study

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

NCT05562206•Pacific Diabetes Technologies

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

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
+12 more criteria

Locations (1)

Rainier Clinical Research Center

Renton, Washington, United States

Key Dates

Start Date

August 30, 2022

Primary Completion Date

October 1, 2022

Completion Date

November 1, 2022

Last Updated

September 30, 2022

Enrollment

ESTIMATED participants

Conditions

Type1diabetes

Interventions

CGMIS (Continuous Glucose Monitoring Infusion Set)

DEVICE

Contacts

Bob Janowski

CONTACT

818-395-6576 bjanowski@pacificdt.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CGMIS 48-hour Feasibility Study

Inclusion Criteria

Exclusion Criteria

Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children

Continuous Ketone Monitoring in People With Type 1 Diabetes Using SGLT2 Inhibitors

Mesenchymal Stromal Cells to Treat Type 1 Diabetes in Children and Adolescents

Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus

Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes

Advanced Glycation Products and Vascular Complications in Type 1 Diabetes