Remote Monitoring in Diabetes Disease Management

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Interventions: Behavioral: DM-Standard; Behavioral: Disease Management Plus

• Registration Number: NCT00675311
• Lead Sponsor: LifeScan

Brief Summary

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.

Detailed Description

To determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-05-08
• Study First Posted: 2008-05-09
• Status Verified: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2009-12-17
• Last Update Posted: 2009-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DM-Standard	DM-Standard	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).
DM-Plus	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 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.

Primary Outcome Measures

Name	Time	Method
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	1 Year

Secondary Outcome Measures

Name	Time	Method
Secondary measures include diabetes-related health-care utilization and physiologic data.	1 Year