Back to resultsRemote Monitoring in Diabetes Disease Management
Primary Purpose
Type 1 Diabetes, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DM-Standard
Disease Management Plus
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Remote monitoring, Type 1 Diabetes, Type 2 diabetes
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
DM-Standard
DM-Plus
Arm Description
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).
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.
Outcomes
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
Secondary Outcome Measures
Secondary measures include diabetes-related health-care utilization and physiologic data.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00675311
Brief Title
Remote Monitoring in Diabetes Disease Management
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
LifeScan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Type 2 Diabetes
Keywords
Remote monitoring, Type 1 Diabetes, Type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DM-Standard
Arm Type
Active Comparator
Arm Description
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).
Arm Title
DM-Plus
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DM-Standard
Intervention Description
Device/t+ Medical Diabetes Management System
Intervention Type
Behavioral
Intervention Name(s)
Disease Management Plus
Intervention Description
Plus is one of the randomized arms of the study. Patients assigned to this arm receive support from Disease Management nurses and technology.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Secondary measures include diabetes-related health-care utilization and physiologic data.
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Fetterolf, MD
Organizational Affiliation
Matria Healthcare
Official's Role
Principal Investigator
Facility Information:
City
Marietta
State/Province
Georgia
Country
United States
12. IPD Sharing Statement
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Remote Monitoring in Diabetes Disease Management
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