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The purpose of this research is to determine if meeting in a group with other subjects with diabetes can reduce barriers to starting insulin.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Education Class Participants | Experimental | Participation in an insulin educational class at week 0 and again at week 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Education Class | Other | Participation in an Insulin Education Class at week 0 and week 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Who Begin Insulin | 2 weeks | |
| Number of Subjects Experiencing Hypoglycemic Symptoms | Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonja K Fredrickson, MD | Hunter Holmes McGuire VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
From April to July 2008, 102 patients were referred to the clinic, and 71 (70%) reported to visit 1. Of these, 32 were excluded: 15 did not bring a glucose log; 7 had HbA1c <8; 1 did not have HbA1c within 1 month; 1 was not referred by PCP; 6 did not consent; 2 were already on insulin. 39 were eligible for the study. 32 completed the study.
Patients were referred by their primary care provider (PCP) through an electronic consult to participate in an insulin education and initiation group visit. All patients received the same education and standard of care; however, only those subjects who signed an informed consent form and met inclusion/exclusion criteria had their data analyzed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Education Class Participants | Subjects attended two group visits, two weeks apart, during which they received education regarding goals of therapy, insulin use, and hypoglycemia. Self-monitored blood glucose values were reviewed and insulin was initiated, if felt appropriate by the physician investigator and if accepted by the subject. 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. Additionally, at the second visit, proportion of blood glucose readings below 70 mg/dl were recorded. All patients were asked how many times in the two weeks they experienced symptoms/signs of low blood sugar, how many times they required sugar intake for the these symptoms, and how many times they required another person to assist them. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Subjects were eligible to participate if they (a) were referred to the group by their primary care provider; (b) had uncontrolled diabetes (hemoglobin A1c (A1c) >= 8.0%) not treated with insulin; (c) brought a glucose log to the first visit and (d) signed a consent form.
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Education Class Participants | Participation in an insulin educational class Group Education: Participation in an insulin educational class |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 32 subjects completed the study | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
Adverse event data were collected at Visit 2, which occurred 2 weeks after Visit 1.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Participation in an insulin educational class Group Education: Participation in an insulin educational class |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subjective Symptoms of hypoglycemia | Endocrine disorders | Systematic Assessment |
This was a pilot study. Limitations include the small sample size and lack of a control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sonja K Fredrickson, MD | Hunter Holmes McGuire VA Medical Center | 804-675-5151 | sonja.fredrickson@va.gov |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Visit 2 (week 2) |
| 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 | 2 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Insulin Education Class Participants | Participation in an insulin educational class Group Education: Participation in an insulin educational class |
|
|
| Secondary | Percent of Patients Who Begin Insulin | Posted | Number | percentage of participants | 2 weeks |
|
|
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| Secondary | Number of Subjects Experiencing Hypoglycemic Symptoms | Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits | As below, 15 subjects reported subjective symptoms of hypoglycemia in the two weeks between study visits; 10 of these subjects had at least one recorded blood glucose value less than 70 mg/dl; Eight of these 10 subjects had started insulin. | Posted | Number | participants | 2 weeks |
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|
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| Secondary | Number of Patients Experiencing a Severe Hypoglycemic Event | Severe hypoglycemia is defined as requiring the help of another person to treat the hypoglycemia | Posted | Number | participants | 2 weeks |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Visit 1 (week 0) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Visit 2 (week 2) |
|
|
|
| 0 |
| 32 |
| 15 |
| 32 |
| Recorded blood glucose less than 70 mg/dl | Endocrine disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
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| Expected hardship from insulin therapy |
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| Stigmatization by insulin injections |
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| Fear of hypoglycemia |
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| Expected hardship from insulin therapy |
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| Stigmatization by insulin injections |
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| Fear of hypoglycemia |
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