DiabetesNCT00824603
Impact of Continuing Medical Education (CME) Insulin Program
An observational study of Diabetes, run by HealthPartners Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- 294 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care providers affiliated with the participating healthcare organizations were invited to attend.
Who may be able to join
- primary care provider attending CME training
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
International Diabetes Center
Minneapolis, Minnesota, 55416
About this study
Official title: Impact of CME Program on Self-Reported Confidence and Use of Insulin in Persons With Type 2 Diabetes
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.
Read the detailed 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?
- Conditions
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| primary care provider | attending insulin CME Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre program survey & 2-4 month post program survey
Secondary outcomes (1)
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
Measured: pre program survey and 2-4 month post program survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startJun 2006
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- International Diabetes Center at Park Nicollet, Eli Lilly and Company, Novo Nordisk A/S, United Health Care, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Margaret Powers, PhD, Principal investigator, International Diabetes Center at Park Nicollet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824603
- Sponsor's protocol ID
- 03425-06-C
- Status last verified
- Aug 2013
- First submitted
- 15 Jan 2009
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of CME Program on Self-Reported Confidence and Use of Insulin in Persons With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00824603
- Acronym / sponsor ID
- 03425-06-C
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- International Diabetes Center at Park Nicollet, Eli Lilly and Company, Novo Nordisk A/S, United Health Care, Merck Sharp & Dohme LLC
- Study start
- Jun 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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?
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| primary care provider | – | –attending insulin CME Training |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care providers affiliated with the participating healthcare organizations were invited to attend.
Key inclusion criteria (1 listed)
- primary care provider attending CME training
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: pre program survey & 2-4 month post program survey
1 secondary outcome
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
Time frame: pre program survey and 2-4 month post program survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Powers, PhD principal investigator
International Diabetes Center at Park Nicollet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: pre program survey & 2-4 month post program survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.