Remote Monitoring in Diabetes Disease Management

December 17, 2009 updated by: LifeScan

A Randomized Study of the Clinical and Economic Impact of Remote Monitoring Program With Disease Management Compared to Conventional Diabetes Disease Management Interventions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Behavioral: DM-Standard
Device/t+ Medical Diabetes Management System
Active Comparator: DM-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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 Year

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary measures include diabetes-related health-care utilization and physiologic data.
Time Frame: 1 Year
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeScan

Investigators

  • Principal Investigator: Donald Fetterolf, MD, Matria Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 8, 2008

First Posted (Estimate)

May 9, 2008

Study Record Updates

Last Update Posted (Estimate)

December 18, 2009

Last Update Submitted That Met QC Criteria

December 17, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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