Remote Monitoring in Diabetes Disease Management

LifeScan300 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Type 1 Diabetes Type 2 Diabetes

Interventions

DM-StandardBEHAVIORAL

Device/t+ Medical Diabetes Management System

Disease Management PlusBEHAVIORAL

Plus is one of the randomized arms of the study. Patients assigned to this arm receive support from Disease Management nurses and technology.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Marietta, Georgia, United States

Outcomes

Primary Outcomes

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 Outcomes

Secondary measures include diabetes-related health-care utilization and physiologic data.

Time frame: 1 Year

Data from ClinicalTrials.gov

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