Remote Monitoring in Diabetes Disease Management - Full Text View

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

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

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:	December 2009
Estimated Primary Completion Date:	December 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.

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)
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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675311

Locations

United States, Georgia

Marietta, Georgia, United States

Sponsors and Collaborators

LifeScan

Investigators

Principal Investigator:

Donald Fetterolf, MD

Matria Healthcare

More Information

No publications provided

Responsible Party:	SymCare Personalized Health Solutions, Inc. ( Cheryl Pegus, M.D. )
Study ID Numbers:	7021
Study First Received:	May 7, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00675311 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by LifeScan:

Remote monitoring
Type 1 Diabetes
Type 2 diabetes

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 10, 2009