Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatments continuous glucose monitor, continuous subcutaneous insulin infusion
Phase phase 4
Sponsor DexCom, Inc.
Collaborator Jaeb Center for Health Research
Start date September 2014
End date November 2016
Trial size 316 participants
Trial identifier NCT02282397, PTL-901148

Summary

Evaluate if addition and use of real time continuous glucose monitoring (RT-CGM) improves glycemic outcome of patients using multiple daily injections (MDI) and self monitoring blood glucose (SMBG) testing, who are not at target glycemic control.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(No Intervention)
Type 1 or Type 2 diabetes mellitus subjects using SMBG testing alone for diabetes management.
(Other)
Type 1 or Type 2 diabetes mellitus subjects using RT-CGM and SMBG testing for diabetes management.
continuous glucose monitor CGM
RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts.
(Other)
Type 1 Diabetes Mellitus subjects using RT-CGM and injections for diabetes management.
continuous glucose monitor CGM
RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts.
(Other)
Type 1 Diabetes Mellitus subjects using RT-CGM and CSII for diabetes management.
continuous glucose monitor CGM
RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts.
continuous subcutaneous insulin infusion insulin pump
Insulin pump with an insulin reservoir, angled infusion set, automated inserter, pumping mechanism and power supply contained in a pod worn on the skin which transmits wirelessly between a Personal Diabetes Manager with built-in Blood Glucose Meter

Primary Outcomes

Measure
A1C change at 6 months
time frame: 6 months

Secondary Outcomes

Measure
Subject A1C goals
time frame: 6 months
A1C change at 12 month
time frame: 6 months
QoL-PROs
time frame: 12 months

Eligibility Criteria

Male or female participants at least 25 years old.

Inclusion Criteria: - Age 25 years or older - Diagnosis of Type 1 diabetes mellitus or insulin-requiring Type 2 diabetes mellitus - Followed regularly by a physician or diabetes educator - Using multiple daily injections - stable control of diabetes - willing to wear a device such as pump or continuous glucose monitor Exclusion Criteria: - recent or planned use of non-insulin injectable hypoglycemic agents - Pregnancy or planning to become pregnant during the study - Medical conditions that make it inappropriate or unsafe to target an A1C of <7% - Renal disease with Glomerular Filtration Rate <45 - Extensive skin changes/disease that precludes wearing the sensor on normal skin - Known allergy to medical-grade adhesives - Recent hospitalization or emergency room visit in the 6 months prior to screening resulting in primary diagnosis of uncontrolled diabetes

Additional Information

Official title Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes
Description Additional assessments will be made to evaluate the incremental benefits of changing the insulin delivery method from MDI to CSII in patients already using CGM. Cost effectiveness and quality of life will be measured between the two groups in each phase.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by DexCom, Inc..