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OpenTrials
Completed

NCT Number: NCT00675311

Remote Monitoring in Diabetes Disease Management

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marietta, Georgia, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DM-Standard

Behavioral

Device/t+ Medical Diabetes Management System

Disease Management Plus

Behavioral

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

Primary outcomes

  1. 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

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

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

LifeScan

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 9, 2008
Registry last updated
Dec 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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