Clinical trial NCT01240200: Satisfaction of Treatment Among Elderly Patients With Insulin Therapy
Official title: Satisfaction of Treatment Among Elderly Patients With Insulin Therapy Using Pens for a Basal Insulin Treatment (STEP IT UP a BIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: diabetes
elderly
insulin injections
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2010-11-15
Enrollment: 49
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Several studies have shown that high blood sugar (glucose) levels are associated with diseases caused by diabetes. Controlling the glucose may prevent these complications. As people age, their bodies become unable to make enough insulin to control the blood sugars. Pills used to treat diabetes may help for a while, but many times this does not last. When the blood sugar is too high, insulin is frequently recommended and used to treat diabetes. Insulin is often started by adding a long-acting insulin to the medicines a patient already takes. In this study, glargine insulin will be taken together with the diabetes pills currently being used. Glargine is a long-acting insulin which is given under the skin once a day. Glargine is approved for use in the treatment of patients with diabetes by the FDA (Food and Drug Administration).

Currently, insulin delivery is only available as a shot. The purpose of this study is to compare how satisfied patients are when using two different types of insulin shots. Specifically, this study aims to determine if people over 65 years old are more satisfied taking insulin shots by pens or syringes. Everyone who joins in this study will have a chance to use the insulin syringes and the insulin pens.

The ability of patients to give themselves shots can affect how well the sugar is controlled. As people age, medical and other problems may develop that affect their ability to do certain things. Another aim of this study is to determine if the ability to use an insulin pen and insulin syringe is affected by age or some other problem.

During this study, participants will be treated with insulin given by a syringe for 12 weeks and by a pen for 12 weeks. Questionnaires will be given to determine satisfaction with treatment throughout the study. The investigators hypothesize that among elderly patients with type 2 diabetes mellitus failing oral agent therapy, treatment with basal insulin via a pen device results in higher treatment satisfaction scores and more accurate dosing than treatment with basal insulin via conventional vial and syringe methods.

A total of 56 subjects with type 2 diabetes will be recruited into this study. The site for the study is Grady Memorial Hospital clinics in Atlanta, Georgia.


Eligibility criteria: Inclusion Criteria:

1. Males or females aged ≥60 years
2. History of type 2 diabetes of \>3 months duration
3. Current use oral antidiabetic agents and/or diet to treat the diabetes
4. A1c ≤10.0% and fasting glucose ≤300 mg/dL
5. A1c ≥7.0% and/or fasting glucose ≥150 mg/dL

Exclusion Criteria:

1. Subjects with a known allergy to glargine or any of its metabolites
2. Subjects unwilling to self-inject insulin
3. Inability to self-monitor blood glucose
4. Current or previous use of insulin for more than 6 continuous months prior to study enrollment
5. Subjects with documented clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, impaired renal function (creatinine \>3.0 mg/dL), uncontrolled endocrine disorders associated with increased insulin resistance such as acromegaly, Cushing's syndrome, or hyperthyroidism
6. Mental condition rendering the subject unable to understand the nature, scope and/or possible consequences of the study
7. Inability or unwillingness to provide informed consent

Primary outcomes:
measure: Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score
timeFrame: Baseline, Week 12
measure: Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc) Score
timeFrame: Week 24
Secondary outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 12
measure: Fasting Blood Glucose
timeFrame: Baseline, Week 12
measure: Percent of Participants With Dosing Errors
timeFrame: Week 24
measure: Number of Hypoglycemic Events
timeFrame: Week 24
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University SOM
name: Christoper Newton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University SOM
name: Dawn Smiley, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References: