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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00824603
Other study ID # 03425-06-C
Secondary ID
Status Completed
Phase N/A
First received January 15, 2009
Last updated November 30, 2015
Start date June 2006
Est. completion date August 2009

Study information

Verified date August 2013
Source HealthPartners Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine if a continuing medical education (CME) program can change primary care providers' use of insulin therapy - their confidence in selecting doses and engagement of patients in the decision making as to whether to initiate insulin therapy.


Description:

We will determine whether attendees' self-reported confidence and use of insulin with persons with type 2 diabetes changes after they attend the CME program. Specifically, we will address the following questions:

Question 1. Clinical guidelines. Is insulin initiated earlier (at a lower A1C)?

Question 2. Decision-making. Does confidence in selecting a starting insulin regimen change? Does confidence in selecting a starting insulin dose change? Does confidence in adjusting insulin change? Does confidence in discussion nutrition guidelines change?

Question 3. Application. Do more patients start using insulin? Who usually selects starting dose? How is starting dose selected? How often is insulin adjusted?

Question 4. Resources. How available are protocols for insulin use? How available is adequate time to monitor insulin therapy? How available is staff to teach insulin injections? How available is staff to help adjust insulin?


Recruitment information / eligibility

Status Completed
Enrollment 294
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years and older
Eligibility Inclusion Criteria:

- primary care provider attending CME training

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States International Diabetes Center Minneapolis Minnesota

Sponsors (6)

Lead Sponsor Collaborator
HealthPartners Institute Eli Lilly and Company, International Diabetes Center at Park Nicollet, Merck Sharp & Dohme Corp., Novo Nordisk A/S, United Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary We will determine whether attendees' self-reported confidence and use of insulin with persons with type 2 diabetes changes after they attend the CME program. pre program survey & 2-4 month post program survey No
Secondary pre-CME training level of patient's A1c when starting insulin therapy compared to post-CME training level of patient's A1c when starting insulin therapy pre program survey and 2-4 month post program survey No
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