Remote Monitoring in Diabetes Disease Management

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675311
• Other study ID #: 7021
• Status: Completed
• Phase: N/A
• First received: May 7, 2008
• Last updated: December 17, 2009
• Start date: March 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: LifeScan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Behavioral:
• DM-Standard
Device/t+ Medical Diabetes Management System
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LifeScan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Secondary measures include diabetes-related health-care utilization and physiologic data.		1 Year	No