Remote Monitoring in Diabetes Disease Management - Diab...

Remote Monitoring in Diabetes Disease Management

Remote Monitoring in Diabetes Disease Management
ClinicalTrials.gov

This study is ongoing, but not recruiting participants.

Sponsored by: LifeScan
Information provided by: LifeScan
ClinicalTrials.gov Identifier: NCT00675311

Purpose

The primary objective of this study is to determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease than a standard disease management program.

Condition Intervention
Type 1 Diabetes
Type 2 Diabetes
Behavioral: DM-Standard
Behavioral: Disease Management Plus

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Official Title: A Randomized Study of the Clinical and Economic Impact of Remote Monitoring Program With Disease Management Compared to Conventional Diabetes Disease Management Interventions

Further study details as provided by LifeScan:

Primary Outcome Measures:

* The primary study measures for this study include glycemic control and LDL levels, satisfaction with diabetes care, and adherence to diabetes medications and self-monitoring recommendations [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

* Secondary measures include diabetes-related health-care utilization and physiologic data. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: March 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
DM-Standard: Active Comparator
The conventional disease management group will receive management under the site's usual program offering, which includes, but is not limited to, compliance with the prescribed treatment regimens, dietary management, exercise programs, and other measures recommended by the American Diabetes Association (ADA) and the Association of American Endocrinologists (AACE).
Behavioral: DM-Standard
Device/t+ Medical Diabetes Management System
DM-Plus: Active Comparator
Plus is one of the randomized arms of the study. Patients assigned to this arm receive support from Disease Management nurses and technology that includes mobile phone client software with web-based companion software, Bluetooth glucose meter cradle, and web-based clinical management software for the clinical management team. The core of the system is the patient's cell phone which is used as an input device and which enables patients to maintain an electronic diary of information such as meal times, blood glucose, insulin use, weight, blood pressure, and exercise. The device is customizable to collect only the information relevant to the patient with diabetes and their healthcare provider. The patient with diabetes enters diary information on his or her mobile phone. No immediate or real-time information is provided to patients as part of this study.
Behavioral: Disease Management Plus
Plus is one of the randomized arms of the study. Patients assigned to this arm receive support from Disease Management nurses and technology.

Detailed Description:

To determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease.
Eligibility
Ages Eligible for Study: 18 Years to 64 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria

* Between 18 and 64 years of age as of January 1, 2008
* Diagnosis of diabetes mellitus (listed ICD-9-CM diagnosis code on two or more outpatient claims, or on one or more inpatient admissions or emergency room claims in the most recent 12-month period)
* Treatment with insulin (one or more outpatient pharmacy claims for insulin in the most recent 12-month period)
* Continuously enrolled in a health plan with pharmacy and medical benefits for the most recent 12-month period or with one period of non-enrollment up to only 30 days
* Recent HbA1c value ≥7.5%
* Able to provide written informed consent for study participation

Exclusion Criteria

* Advanced renal disease (one or more claims in the most recent 12-month period) as defined by a claim for nephropathy or creatinine greater than 2.5 mg/dl
* Selected cancers (one or more claims in the most recent 12-month period)
* HIV/AIDS (one or more claims in the most recent 12-month period)
* Heart, liver, kidney, or multiple organ transplant (one or more claims in the most recent 12-month period)
* Cirrhosis of the liver (one or more claims in the most recent 12-month period)
* Current participation in another LifeScan study or other diabetes-related clinical trials
* Medicare is primary source of insurance coverage
* Unable to understand written and spoken English