Remote Monitoring in Diabetes Disease Management

LifeScan

Status: Completed

Conditions: Type 1 Diabetes; Type 2 Diabetes

Treatments: Behavioral: DM-Standard; Behavioral: Disease Management Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00675311

7021

Details and patient eligibility

About

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.

Full description

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

DM-Standard

Active Comparator group

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).

Treatment:

Behavioral: DM-Standard

DM-Plus

Active Comparator group

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.

Treatment:

Behavioral: Disease Management Plus