Diabetes Mellitus, Type 2NCT00645528

Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?

A study testing Insulin Education Class in people with Diabetes Mellitus, Type 2, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this research is to determine if meeting in a group with other subjects with diabetes can reduce barriers to starting insulin. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Insulin Education Class
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: Apr 2008to Sep 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Primary care patient at McGuire Veterans Affairs Medical Center in Richmond, Virginia
Age > 18 years
Inadequately controlled diabetes (HbA1c > 8.0%) and not on insulin (using most recent HbA1c, within 1 month of the first visit)
Primary Care Provider referral to insulin initiation/education group
Patient brings home glucose readings to first visit

Who cannot join

Patient is reluctant to participate in a group visit for any reason
Patient unwilling to sign consent form

Trial locations and contacts

1 site in 1 country.

United States1 site

Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249

Other trials in United States

About this study

The purpose of this research is to determine if meeting in a group with other subjects with diabetes can reduce barriers to starting insulin.

Read the detailed description

Diabetes is a common, morbid and expensive disease among veterans. Achieving and maintaining adequate glycemic control can reduce the devastating complications of diabetes. Unfortunately a large percentage of veterans with type 2 diabetes continue to have poorly controlled blood sugars. Insulin is the most potent medication for reducing glycemia, but is not used often enough due to barriers that are both patient and provider driven.

We propose to conduct a pilot study to evaluate the feasibility of establishing an insulin education group that would serve to educate patients about insulin, to initiate insulin in a group setting, and to provide appropriate follow-up of those who start insulin. If the intervention is successful, we plan to develop a multicenter study to test rigorously the effect of this approach.

Specific Aims:

To determine if psychological barriers to insulin initiation in patients with uncontrolled type 2 diabetes are favorably affected by a group insulin education and insulin initiation visit, as measured by the Barriers to Insulin Treatment (BIT) Questionaire before and after the intervention.

To evaluate the feasibility of the intervention as measured by the percent of patients who are referred to the class, but either cancel without rescheduling or fail to report and the percent of patients who begin insulin.

To evaluate the safety of the intervention as measured by the proportion of patients experiencing hypoglycemic symptoms; proportion of patients requiring sugar intake to manage hypoglycemia; and the proportion of patients requiring assistance to manage hypoglycemia.

Conditions: Diabetes Mellitus, Type 2
Being tested: Insulin Education Class
Keywords: insulin, teaching
Medical subject headings: Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insulin Education ClassOther
Participation in an Insulin Education Class at week 0 and week 2

Study groups in NCT00645528
Study group	Role	What they receive
Insulin Education Class Participants	Experimental	Participation in an insulin educational class at week 0 and again at week 2 Receives: Other: Insulin Education Class

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in "Barriers to Insulin Treatment (BIT)" Score From Before to After the Classes
The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale ("Expectations regarding positive insulin-related outcomes") where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. Reported here is the change in BIT score from baseline. This was assessed by paired t-test.
Measured: 2 weeks
Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0)
The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10 point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale ("Expectations regarding positive insulin-related outcomes") where the lower the score, the greater the barriers to insulin treatment. An overall sum score can be calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 1 is reported here.
Measured: Visit 1 (week 0)
Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2)
The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale ("Expectations regarding positive insulin-related outcomes") where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 2 is reported here.
Measured: Visit 2 (week 2)

Secondary outcomes (3)

Percent of Patients Who Begin Insulin
Measured: 2 weeks
Number of Subjects Experiencing Hypoglycemic Symptoms
Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits
Measured: 2 weeks
Number of Patients Experiencing a Severe Hypoglycemic Event
Severe hypoglycemia is defined as requiring the help of another person to treat the hypoglycemia
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Sep 2008

First posted27 Mar 2008 (estimated)
Study startApr 2008
Primary completionAug 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies 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: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00645528
Sponsor's protocol ID: SHP 08-198
Status last verified: May 2015
First submitted: 21 Mar 2008
Last updated: 8 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?
ClinicalTrials.gov ID: NCT00645528
Acronym / sponsor ID: SHP 08-198
Conditions: Diabetes Mellitus, Type 2
Keywords: insulin, teaching
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: US Department of Veterans AffairsUS federal agency
Study start: Apr 2008
Primary completion: Aug 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 27 Mar 2008 (estimated)
Results: Posted 8 May 2015

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 research is to determine if meeting in a group with other subjects with diabetes can reduce barriers to starting insulin.

Detailed description

Specific Aims:

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Insulin Education Class Participants	Experimental	Other: Insulin Education ClassParticipation in an insulin educational class at week 0 and again at week 2

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Primary care patient at McGuire Veterans Affairs Medical Center in Richmond, Virginia
Age > 18 years
Inadequately controlled diabetes (HbA1c > 8.0%) and not on insulin (using most recent HbA1c, within 1 month of the first visit)
Primary Care Provider referral to insulin initiation/education group
Patient brings home glucose readings to first visit

Key exclusion criteria (2 listed)

Patient is reluctant to participate in a group visit for any reason
Patient unwilling to sign consent form

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Insulin Education ClassParticipation in an Insulin Education Class at week 0 and week 2	Other	Insulin Education Class Participants

Primary outcome

Change in "Barriers to Insulin Treatment (BIT)" Score From Before to After the Classes
Time frame: 2 weeks
The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale ("Expectations regarding positive insulin-related outcomes") where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. Reported here is the change in BIT score from baseline. This was assessed by paired t-test.
Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0)
Time frame: Visit 1 (week 0)
The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10 point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale ("Expectations regarding positive insulin-related outcomes") where the lower the score, the greater the barriers to insulin treatment. An overall sum score can be calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 1 is reported here.
Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2)
Time frame: Visit 2 (week 2)
The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale ("Expectations regarding positive insulin-related outcomes") where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 2 is reported here.

3 secondary outcomes

Percent of Patients Who Begin Insulin
Time frame: 2 weeks
Number of Subjects Experiencing Hypoglycemic Symptoms
Time frame: 2 weeks
Number of Patients Experiencing a Severe Hypoglycemic Event
Time frame: 2 weeks

Results and safety

Results posted to the registry on 8 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin Education Class Participants	39	32

Primary outcome: Change in "Barriers to Insulin Treatment (BIT)" Score From Before to After the Classes

Time frame: 2 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Insulin Education Class Participants n = 32
Change in Total Sum Score	-0.76 (1.46)
Change in Fear of Injections and Self-Testing	-0.42 (2.95)
Change in Expectations regarding positive insulin	0.88 (2.44)
Change in Expected hardship from insulin therapy	-0.55 (2.62)
Change in Stigmatization by insulin injections	-1.1 (2.33)
Change in Fear of hypoglycemia	-1.02 (3.44)

Population analysed: 32 subjects completed the study

Primary outcome: Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0)

Time frame: Visit 1 (week 0). Mean (Standard Deviation). Unit: units on a scale

Measure	Insulin Education Class Participants n = 32
Total Sum Score	4.27 (1.29)
Fear of injections and self-testing	3.06 (2.24)
Expectations regarding positive insulin-related ou	5.59 (2.31)
Expected hardship from insulin therapy	4.16 (2.12)
Stigmatization by insulin injections	4.14 (1.74)
Fear of hypoglycemia	4.69 (2.62)

Primary outcome: Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2)

Time frame: Visit 2 (week 2). Mean (Standard Deviation). Unit: units on a scale

Measure	Insulin Education Class Participants n = 32
Total Sum Score	3.51 (1.41)
Fear of injections and self-testing	2.64 (2.30)
Expectations regarding positive insulin-related ou	6.47 (1.84)
Expected hardship from insulin therapy	3.61 (2.29)
Stigmatization by insulin injections	3.13 (2.00)
Fear of hypoglycemia	3.79 (2.24)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected at Visit 2, which occurred 2 weeks after Visit 1.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1	0 of 32 (0%)	15 of 32 (46.9%)	Not reported

Limitations and caveats (from the sponsor): This was a pilot study. Limitations include the small sample size and lack of a control group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Sonja K Fredrickson, MD principal investigator

Hunter Holmes McGuire VA Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Insulin Education Class in people with Diabetes Mellitus, Type 2, run by US Department of Veterans Affairs 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 5 inclusion and 2 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 8 May 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?

Yes. Results are posted in the registry (first posted 8 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in "Barriers to Insulin Treatment (BIT)" Score From Before to After the Classes (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00645528.

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 8 May 2015.