NCT00675311

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 18, 2009

Status Verified

December 1, 2009

Enrollment Period

1.8 years

First QC Date

May 7, 2008

Last Update Submit

December 17, 2009

Conditions

Type 1 DiabetesType 2 Diabetes

Keywords

Remote monitoringType 1 DiabetesType 2 diabetes

Outcome Measures

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

    1 Year

Secondary Outcomes (1)

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

    1 Year

Study Arms (2)

DM-Standard

ACTIVE COMPARATOR

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).

Behavioral: DM-Standard

DM-Plus

ACTIVE COMPARATOR

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.

Behavioral: Disease Management Plus

Interventions

DM-StandardBEHAVIORAL

Device/t+ Medical Diabetes Management System

DM-Standard
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.

DM-Plus

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Marietta, Georgia, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Disease Management

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services Administration

Study Officials

  • Donald Fetterolf, MD

    Matria Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 9, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 18, 2009

Record last verified: 2009-12

Locations

US(1)