Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study

NCT02877771 | Completed Phase 1

• 1 other identifier: 010300
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to assess the functionality of an integrated predictive low glucose suspend system designed to minimize the incidence and duration of hypoglycemia by suspending insulin delivery if hypoglycemia is projected.

Conditions

Diabetes Mellitus; Type 1 Diabetes; Insulin Pump

Outcome Measures

Primary Outcomes (3)

• Suspension of Insulin Delivery

  To test functionality of the system

  8 hours between 9pm and 5am

• Restoration of insulin delivery

  To test functionality of the system

  8 hours between 9pm and 5am

• Agreement between algorithm-recommended pump action

  To test functionality of the system

  8 hours between 9pm and 5am

Other Outcomes (3)

• Duration of insulin suspension

  8 hours between 9pm and 5am

• Continuous Glucose Monitoring (CGM) glucose nadir

  8 hours between 9pm and 5am

• Reference blood glucose

  8 hours between 9pm and 5am

Study Arms (1)

t:slim insulin pump with predictive low glucose suspend

EXPERIMENTAL

To assess the functionality of a predictive low glucose suspend (PLGS) system that uses CGM values to suspend basal insulin delivery when hypoglycemia is predicted as well as resume basal insulin delivery once Continuous Glucose Monitoring (CGM) values begin to increase.

Device: t:slim insulin pump with predictive low glucose suspend

Interventions

t:slim insulin pump with predictive low glucose suspend DEVICE

To assess the functionality of a predictive low glucose suspend (PLGS) system that uses Continuous Glucose Monitoring (CGM) values to suspend basal insulin delivery when hypoglycemia is predicted as well as resume basal insulin delivery once Continuous Glucose Monitoring (CGM) values begin to increase.

t:slim insulin pump with predictive low glucose suspend

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 1 diabetes requiring insulin therapy for at least 12 months
• Insulin pump therapy for at least 6 months
• Age ≥18.0 years
• Subject demonstrates stable insulin regimen including basal rates, insulin sensitivity factor and insulin:carbohydrate ratio for at least 3 months

You may not qualify if:

• Pregnant (female subjects must have negative urine or serum pregnancy screening test)
• Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment
• Diabetic ketoacidosis in the month prior to enrollment
• A current condition that would prevent the use of a CGM sensor or insulin pump, or in the judgment of the investigator is a contraindication to study participation
• Use of acetaminophen during study participation
• Current use of any medication intended to lower glucose other than insulin including naturaceuticals, oral or non-insulin injectable medications

Sponsors & Collaborators

• Tandem Diabetes Care, Inc.: lead
• Jaeb Center for Health Research: collaborator

Study Sites (2)

Stanford University

Palo Alto, California, 94304, United States

Location

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 24, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

US (2)