Trial Outcomes & Findings for Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation? (NCT NCT00645528)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

2 weeks

Results posted on

2015-05-08

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	39
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Did not show up for Visit 2	7

Baseline Characteristics

Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insulin Education Class Participants n=39 Participants Participation in an insulin educational class Group Education: Participation in an insulin educational class
Age, Continuous	65 years STANDARD_DEVIATION 11.3 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	39 Participants n=99 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: 32 subjects completed the study

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.

Outcome measures

Outcome measures
Measure	Insulin Education Class Participants n=32 Participants Participation in an insulin educational class Group Education: Participation in an insulin educational class
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
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
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
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
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
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

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Insulin Education Class Participants n=32 Participants Participation in an insulin educational class Group Education: Participation in an insulin educational class
Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0) Total Sum Score	4.27 units on a scale Standard Deviation 1.29
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
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
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
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
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Insulin Education Class Participants n=32 Participants Participation in an insulin educational class Group Education: Participation in an insulin educational class
Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2) Total Sum Score	3.51 units on a scale Standard Deviation 1.41
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 2.30
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
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
Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2) Stigmatization by insulin injections	3.13 units on a scale Standard Deviation 2.00
Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2) Fear of hypoglycemia	3.79 units on a scale Standard Deviation 2.24

SECONDARY outcome

Timeframe: 2 weeks

Outcome measures

Outcome measures
Measure	Insulin Education Class Participants n=32 Participants Participation in an insulin educational class Group Education: Participation in an insulin educational class
Percent of Patients Who Begin Insulin	78 percentage of participants

SECONDARY outcome

Timeframe: 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.

Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits

Outcome measures

Outcome measures
Measure	Insulin Education Class Participants n=32 Participants Participation in an insulin educational class Group Education: Participation in an insulin educational class
Number of Subjects Experiencing Hypoglycemic Symptoms	15 participants

SECONDARY outcome

Timeframe: 2 weeks

Severe hypoglycemia is defined as requiring the help of another person to treat the hypoglycemia

Outcome measures

Outcome measures
Measure	Insulin Education Class Participants n=32 Participants Participation in an insulin educational class Group Education: Participation in an insulin educational class
Number of Patients Experiencing a Severe Hypoglycemic Event	0 participants

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm 1 n=32 participants at risk Participation in an insulin educational class Group Education: Participation in an insulin educational class
Endocrine disorders Subjective Symptoms of hypoglycemia	46.9% 15/32 • Adverse event data were collected at Visit 2, which occurred 2 weeks after Visit 1.
Endocrine disorders Recorded blood glucose less than 70 mg/dl	31.2% 10/32 • Adverse event data were collected at Visit 2, which occurred 2 weeks after Visit 1.

Additional Information

Sonja K Fredrickson, MD

Hunter Holmes McGuire VA Medical Center

Phone: 804-675-5151

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place