Diabetes Mellitus, Type 2
Conditions
Keywords
insulin, teaching
Brief 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.
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.
Interventions
OTHERInsulin Education Class
Participation in an Insulin Education Class at week 0 and week 2
Sponsors
US Department of Veterans Affairs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Patient is reluctant to participate in a group visit for any reason * Patient unwilling to sign consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Barriers to Insulin Treatment (BIT) Score From Before to After the Classes | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Who Begin Insulin | 2 weeks | — |
| Number of Subjects Experiencing Hypoglycemic Symptoms | 2 weeks | Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits |
| Number of Patients Experiencing a Severe Hypoglycemic Event | 2 weeks | Severe hypoglycemia is defined as requiring the help of another person to treat the hypoglycemia |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Insulin Education Class Participants Participation in an insulin educational class
Group Education: Participation in an insulin educational class | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not show up for Visit 2 | 7 |
Baseline characteristics
| Characteristic | Insulin Education Class Participants |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
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.
Time frame: Visit 1 (week 0)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Education Class Participants | Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0) | Total Sum Score | 4.27 units on a scale | Standard Deviation 1.29 |
| Insulin Education Class Participants | Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0) | Fear of injections and self-testing | 3.06 units on a scale | Standard Deviation 2.24 |
| Insulin Education Class Participants | Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0) | Expectations regarding positive insulin-related ou | 5.59 units on a scale | Standard Deviation 2.31 |
| Insulin Education Class Participants | Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0) | Expected hardship from insulin therapy | 4.16 units on a scale | Standard Deviation 2.12 |
| Insulin Education Class Participants | Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0) | Stigmatization by insulin injections | 4.14 units on a scale | Standard Deviation 1.74 |
| Insulin Education Class Participants | Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0) | Fear of hypoglycemia | 4.69 units on a scale | Standard Deviation 2.62 |
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.
Time frame: Visit 2 (week 2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Education Class Participants | Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2) | Total Sum Score | 3.51 units on a scale | Standard Deviation 1.41 |
| Insulin Education Class Participants | Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2) | Fear of injections and self-testing | 2.64 units on a scale | Standard Deviation 2.3 |
| Insulin Education Class Participants | Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2) | Expectations regarding positive insulin-related ou | 6.47 units on a scale | Standard Deviation 1.84 |
| Insulin Education Class Participants | Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2) | Expected hardship from insulin therapy | 3.61 units on a scale | Standard Deviation 2.29 |
| Insulin Education Class Participants | Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2) | Stigmatization by insulin injections | 3.13 units on a scale | Standard Deviation 2 |
| Insulin Education Class Participants | Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2) | Fear of hypoglycemia | 3.79 units on a scale | Standard Deviation 2.24 |
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.
Time frame: 2 weeks
Population: 32 subjects completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Education Class Participants | Change in Barriers to Insulin Treatment (BIT) Score From Before to After the Classes | Change in Total Sum Score | -0.76 units on a scale | Standard Deviation 1.46 |
| Insulin Education Class Participants | Change in Barriers to Insulin Treatment (BIT) Score From Before to After the Classes | Change in Fear of Injections and Self-Testing | -0.42 units on a scale | Standard Deviation 2.95 |
| Insulin Education Class Participants | Change in Barriers to Insulin Treatment (BIT) Score From Before to After the Classes | Change in Expectations regarding positive insulin | 0.88 units on a scale | Standard Deviation 2.44 |
| Insulin Education Class Participants | Change in Barriers to Insulin Treatment (BIT) Score From Before to After the Classes | Change in Expected hardship from insulin therapy | -0.55 units on a scale | Standard Deviation 2.62 |
| Insulin Education Class Participants | Change in Barriers to Insulin Treatment (BIT) Score From Before to After the Classes | Change in Stigmatization by insulin injections | -1.1 units on a scale | Standard Deviation 2.33 |
| Insulin Education Class Participants | Change in Barriers to Insulin Treatment (BIT) Score From Before to After the Classes | Change in Fear of hypoglycemia | -1.02 units on a scale | Standard Deviation 3.44 |
Secondary
Number of Patients Experiencing a Severe Hypoglycemic Event
Severe hypoglycemia is defined as requiring the help of another person to treat the hypoglycemia
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Education Class Participants | Number of Patients Experiencing a Severe Hypoglycemic Event | 0 participants |
Secondary
Number of Subjects Experiencing Hypoglycemic Symptoms
Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Education Class Participants | Number of Subjects Experiencing Hypoglycemic Symptoms | 15 participants |
Secondary
Percent of Patients Who Begin Insulin
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Education Class Participants | Percent of Patients Who Begin Insulin | 78 percentage of participants |