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Outcomes and Cost Consequences of Using an Internet Co-Management Module to Improve the Quality of Type 1 Diabetes Care

Outcomes and Cost Consequences of Using an Internet Co-Management Module to Improve the Quality of Type 1 Diabetes Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00194558
Enrollment
82
Registered
2005-09-19
Start date
2005-02-28
Completion date
Unknown
Last updated
2008-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes, Health Education, Information Technology, Disease Management, Internet, Patient Education

Brief summary

The researchers will conduct a 12-month randomized controlled trial comparing usual care versus chronic disease management using the Internet among patients with type 1 diabetes receiving care in the Diabetes Care Center at the University of Washington.

Detailed description

We will conduct a 12-month randomized controlled trial comparing usual care versus chronic disease management using the Internet among patients with type 1 diabetes on multiple daily injections with insulin glargine and rapid-acting analogs. Specifically, the objectives of the study are to: 1. Evaluate the difference in glycemic control (HbA1c) between intervention and control, 2. Evaluate the difference in resource utilization and costs of care between intervention and control, and 3. Evaluate the difference in satisfaction with care between intervention and control. A total of 80-85 subjects will be recruited from patients receiving care in the Diabetes Care Center (DCC) at the University of Washington in Seattle. As part of a pretest-posttest experimental design, intervention-group subjects will be trained in the use of an existing diabetes disease-management module comprising six related Web sites that are accessed from home via links displayed within the University's MyUW Internet portal. These sites allow patients to: 1. View their entire electronic medical record including clinical reminders, the same record used by providers, 2. Upload blood glucose readings stored in a digital meter, 3. Manually enter medication, nutrition, and exercise data into an online daily diary, 4. Communicate with providers regarding treatment recommendations or other questions using a clinical e-mail service, 5. Obtain additional information from a traditional education site whose content and links were sanctioned by the Medical Director of the DCC, and 6. Employ a second education site to collaboratively generate action plans intended to enhance self-efficacy. In addition to login and password protection, access to confidential information from home requires the use of secondary authentication (SecureID). All clinical and other data can be viewed by patients and providers in online trended displays that will be used by a nurse practitioner to review cases no less than weekly. As the control group, subjects receiving usual care will not have access to the diabetes module and related case-management services being evaluated. The primary clinical outcome for the study is the between group differences in glycemic control using HbA1c as the metric. A co-primary outcome is all direct medical care utilization. Satisfaction with diabetes care, employing both a quantitative survey (Patient Assessment of Chronic Illness Care) and semi-structured interviews performed on a 20% purposive sub-sample of intervention patients, is a secondary outcome measure.

Interventions

Sponsors

Aventis Pharmaceuticals
CollaboratorINDUSTRY
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No

Inclusion criteria

* Computer and Internet access at home * Receiving care at the University of Washington Diabetes Care Center

Exclusion criteria

* Non-English speaking

Design outcomes

Primary

MeasureTime frame
Hemoglobin A1c

Secondary

MeasureTime frame
Utilization
Satisfaction with care

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026