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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01339208
Other study ID # PRO10100547
Secondary ID
Status Completed
Phase N/A
First received April 14, 2011
Last updated May 26, 2015
Start date June 2011
Est. completion date March 2015

Study information

Verified date April 2011
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility and clinical efficacy of an innovative care model that combines Telemedicine consultations, educator therapeutic management and diabetes education to empower patients to be in greater control of their own diabetes care for improvements in diabetes outcomes.


Description:

This study will assess whether a new care delivery model combining telemedicine videoconference diabetes consultations with diabetes self-management teaching is efficacious in reducing HbA1c in patients with type 2 diabetes in rural areas. The control group will consist of patients with type 2 diabetes receiving "usual care", i.e., who have not received a referral to the endocrinologist telemedicine team. Secondary outcomes include patient satisfaction, level of understanding of self-management skills, and hypoglycemia


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 or older with type 2 diabetes

- Referral by a primary care provider.

- HbA1c equal or greater than 7.0%.

Exclusion Criteria:

- Type 1 diabetes

- Gestational Diabetes

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Telemedicine diabetes intervention
3 month duration telemedicine consultation and diabetes education

Locations

Country Name City State
United States UPMC Northwest Seneca Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HbA1c % from baseline 3 and 6 month No
Secondary Patient satisfaction 6 month No
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