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Completed

NCT Number: NCT00645528

Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin Education Class

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Percent of Patients Who Begin Insulin

    Time frame: 2 weeks

  2. Number of Subjects Experiencing Hypoglycemic Symptoms

    Time frame: 2 weeks

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

  3. Number of Patients Experiencing a Severe Hypoglycemic Event

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 27, 2008
Registry last updated
May 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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