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Clinical Trial Details

Trial ID: L5702
Source ID: NCT01240200
Associated Drug: Glargine
Title: Satisfaction of Treatment Among Elderly Patients With Insulin Therapy
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01240200/results
Conditions: Diabetes Mellitus
Interventions: DRUG: Glargine|DEVICE: glargine via insulin pen
Outcome Measures: Primary: Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score, Treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs). The questionnaire contains eight items scored on a seven-point scale where 0 = very dissatisfied and 6 = very satisfied. The satisfaction score is obtained from summing responses to questions 1, 4, 5, 6, 7, and 8 and the total score can range from 0 to 36. Higher scores indicate higher satisfaction with diabetes treatment., Baseline, Week 12|Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc) Score, Treatment satisfaction after crossover into the second treatment period was assessed using the Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc). The questionnaire contains eight items scored on a seven-point scale where -3 = much less satisfied now and 3 = much more satisfied now. The satisfaction score is obtained from summing responses to questions 1, and 4 through 8 (the remaining two items assess perceived blood sugar levels). The total score can range from -18 to 18. Higher scores indicate higher satisfaction with the new diabetes treatment, compared to prior treatment, while scores below 0 mean that satisfaction with the new delivery method of insulin in Period 2 is lower than satisfaction with the delivery method in Period 1., Week 24 | Secondary: Hemoglobin A1c (HbA1c), Hemoglobin A1c (HbA1c) measures the average percentage of blood sugar over the past 2 to 3 months. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. HbA1c can reduce with management of diabetes through diet, exercise, and medication., Baseline, Week 12|Fasting Blood Glucose, Blood sugar levels are influenced by the size and types of food consumed during the last meal and the production and response to insulin. Fasting blood glucose levels of less than 100 milligrams per deciliter (mg/dL) are considered normal. Values between 100 and 125 mg/dL indicate prediabetes and values of 126 mg/dL and higher indicate diabetes. Fasting blood glucose levels can lower depending on food consumed and medications., Baseline, Week 12|Percent of Participants With Dosing Errors, Percentage of participants who had dosing errors during the course of the study (both study periods). Participants were instructed on using each device and practiced preparing and injecting the insulin dose into a pillow to assess accuracy with each method of delivering insulin. Dosing errors were defined as inaccurate preparation or injection by less than or equal to 10% of the intended dose, independent of vision and dexterity function., Week 24|Number of Hypoglycemic Events, The number of hypoglycemic events occurring during the 24-week study period is reported here. For the purposes of this study, hypoglycemia is defined as a capillary and/or laboratory blood glucose value of less than 70 mg/dL., Week 24
Sponsor/Collaborators: Sponsor: Emory University | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 49
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-01
Completion Date: 2012-12
Results First Posted: 2014-10-30
Last Update Posted: 2018-10-31
Locations: Grady Memorial Hospital, Atlanta, Georgia, 30303, United States
URL: https://clinicaltrials.gov/show/NCT01240200