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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00700908
Other study ID # 0701M99406
Secondary ID
Status Completed
Phase N/A
First received June 17, 2008
Last updated February 20, 2013
Start date June 2007
Est. completion date June 2008

Study information

Verified date February 2013
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Aim 1. Determine the impact of a daily, automated telephone intervention on HbA1c levels compared to standard care in older patients with type 2 diabetes.

Aim 2. Determine the impact of the automated telephone intervention compared to standard care on adherence to prescribed SMBG frequency in older patients with type 2 diabetes.

Aim 3. Determine the impact of the automated telephone intervention compared to standard care on self-reported diabetic control problems in older patients with type 2 diabetes.

Aim 4. Determine the impact of the automated telephone intervention compared to standard care on self-reported attitudes and health beliefs concerning diabetes in older patients with type 2 diabetes


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 55 Years and older
Eligibility Inclusion Criteria:

- Age greater or equal to 55

- Type 2 diabetes

- English speaking

- Ability to use glucose meter

Exclusion Criteria:

- Unable to give informed consent

- Unwilling to allow SMBG levels to be shard with primary care physician

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
automated telephone intervention vs. usual care


Locations

Country Name City State
United States Primary Care Center University of Minnesota Minneapolis Minnesota

Sponsors (2)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HbA1c three months No
Secondary Change in adherence to SMBG frequency three months No
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