Trial Outcomes & Findings for Satisfaction of Treatment Among Elderly Patients With Insulin Therapy (NCT NCT01240200)
NCT ID: NCT01240200
Last Updated: 2018-10-31
Results Overview
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.
COMPLETED
PHASE4
49 participants
Baseline, Week 12
2018-10-31
Participant Flow
Enrollment of subjects started in January 2011 and all study participation was completed in December 2012. Patients were recruited from the Grady Memorial Hospital Diabetes Clinic in Atlanta, Georgia.
Of the 56 individuals who consented to take part in the study, 7 were removed prior to being randomized to a group (2 did not meet eligibility criteria and 5 withdrew consent prior to group assignment). Those who were not randomized were not considered to be enrolled in the study as group assignment was never determined.
Participant milestones
| Measure |
Vial & Syringe (Period 1) / Pen (Period 2)
Crossover study group where participants were randomized to the sequence of insulin glargine via vial and syringe in Period 1 and insulin glargine via SoloSTAR pen in Period 2.
|
Pen (Period 1) / Vial & Syringe (Period 2)
Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2.
|
|---|---|---|
|
12-week Crossover Phase - Period 1
STARTED
|
25
|
24
|
|
12-week Crossover Phase - Period 1
COMPLETED
|
23
|
23
|
|
12-week Crossover Phase - Period 1
NOT COMPLETED
|
2
|
1
|
|
12-week Crossover Phase - Period 2
STARTED
|
23
|
23
|
|
12-week Crossover Phase - Period 2
COMPLETED
|
23
|
23
|
|
12-week Crossover Phase - Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Vial & Syringe (Period 1) / Pen (Period 2)
Crossover study group where participants were randomized to the sequence of insulin glargine via vial and syringe in Period 1 and insulin glargine via SoloSTAR pen in Period 2.
|
Pen (Period 1) / Vial & Syringe (Period 2)
Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2.
|
|---|---|---|
|
12-week Crossover Phase - Period 1
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Satisfaction of Treatment Among Elderly Patients With Insulin Therapy
Baseline characteristics by cohort
| Measure |
Vial & Syringe (Period 1) / Pen (Period 2)
n=23 Participants
Crossover study group where participants were randomized to the sequence of insulin glargine via vial and syringe in Period 1 and insulin glargine via SoloSTAR pen in Period 2.
|
Pen (Period 1) / Vial & Syringe (Period 2)
n=23 Participants
Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
70.6 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
68.8 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: This analysis includes participants who completed the baseline and week 12 assessments.
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.
Outcome measures
| Measure |
Vial & Syringe (Period 1) / Pen (Period 2)
n=23 Participants
Crossover study group where participants were randomized to the sequence of insulin glargine via vial and syringe in Period 1 and insulin glargine via SoloSTAR pen in Period 2.
|
Pen (Period 1) / Vial & Syringe (Period 2)
n=23 Participants
Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2.
|
|---|---|---|
|
Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score
Baseline
|
28.2 units on a scale
Standard Deviation 7.0
|
31.5 units on a scale
Standard Deviation 4.9
|
|
Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score
Week 12
|
32.2 units on a scale
Standard Deviation 5.2
|
34.2 units on a scale
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Week 24Population: This analysis includes participants who completed the week 12 and week 24 assessments.
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.
Outcome measures
| Measure |
Vial & Syringe (Period 1) / Pen (Period 2)
n=23 Participants
Crossover study group where participants were randomized to the sequence of insulin glargine via vial and syringe in Period 1 and insulin glargine via SoloSTAR pen in Period 2.
|
Pen (Period 1) / Vial & Syringe (Period 2)
n=23 Participants
Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2.
|
|---|---|---|
|
Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc) Score
|
16.4 units on a scale
Standard Deviation 2.7
|
-2.3 units on a scale
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants with HbA1c measurements at baseline and week 12 are included in this analysis.
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.
Outcome measures
| Measure |
Vial & Syringe (Period 1) / Pen (Period 2)
n=23 Participants
Crossover study group where participants were randomized to the sequence of insulin glargine via vial and syringe in Period 1 and insulin glargine via SoloSTAR pen in Period 2.
|
Pen (Period 1) / Vial & Syringe (Period 2)
n=23 Participants
Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2.
|
|---|---|---|
|
Hemoglobin A1c (HbA1c)
Baseline
|
8.7 percentage of Hemoglobin A1c
Standard Deviation 1.1
|
8.5 percentage of Hemoglobin A1c
Standard Deviation 1.3
|
|
Hemoglobin A1c (HbA1c)
Week 12
|
7.6 percentage of Hemoglobin A1c
Standard Deviation 0.8
|
7.6 percentage of Hemoglobin A1c
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants with fasting blood glucose measurements at baseline and week 12 are included in this analysis.
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.
Outcome measures
| Measure |
Vial & Syringe (Period 1) / Pen (Period 2)
n=23 Participants
Crossover study group where participants were randomized to the sequence of insulin glargine via vial and syringe in Period 1 and insulin glargine via SoloSTAR pen in Period 2.
|
Pen (Period 1) / Vial & Syringe (Period 2)
n=23 Participants
Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2.
|
|---|---|---|
|
Fasting Blood Glucose
Baseline
|
159 mg/dL
Standard Deviation 47
|
157 mg/dL
Standard Deviation 38
|
|
Fasting Blood Glucose
Week 12
|
126 mg/dL
Standard Deviation 19
|
134 mg/dL
Standard Deviation 32
|
SECONDARY outcome
Timeframe: Week 24Population: All participants completing the study are included in this analysis (23 in dosing sequence 1 and 23 in dosing sequence 2).
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.
Outcome measures
| Measure |
Vial & Syringe (Period 1) / Pen (Period 2)
n=46 Participants
Crossover study group where participants were randomized to the sequence of insulin glargine via vial and syringe in Period 1 and insulin glargine via SoloSTAR pen in Period 2.
|
Pen (Period 1) / Vial & Syringe (Period 2)
n=46 Participants
Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2.
|
|---|---|---|
|
Percent of Participants With Dosing Errors
|
90 percentage of participants
|
20 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: All participants completing the study are included in this analysis (23 in dosing sequence 1 and 23 in dosing sequence 2).
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.
Outcome measures
| Measure |
Vial & Syringe (Period 1) / Pen (Period 2)
n=46 Participants
Crossover study group where participants were randomized to the sequence of insulin glargine via vial and syringe in Period 1 and insulin glargine via SoloSTAR pen in Period 2.
|
Pen (Period 1) / Vial & Syringe (Period 2)
n=46 Participants
Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2.
|
|---|---|---|
|
Number of Hypoglycemic Events
|
72 hypoglycemic events
|
36 hypoglycemic events
|
Adverse Events
Vial and Syringe
SoloSTAR Pen
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vial and Syringe
n=48 participants at risk
Participants, from both dosing sequences (Period 1 and Period 2), using a vial and syringe during the study to self-administer insulin.
|
SoloSTAR Pen
n=47 participants at risk
Participants, from both dosing sequences (Period 1 and Period 2), using the SoloSTAR Pen during the study to self-administer insulin.
|
|---|---|---|
|
Endocrine disorders
Hypoglycemia
|
45.8%
22/48 • Number of events 72 • Adverse events were collected from the time study treatment began through the completion of both 12-week periods of the study (up to 24 weeks). Twenty-five participants began the vial and syringe delivery method in Period 1 and 23 participants began this intervention in Period 2, resulting in 48 participants receiving this intervention. For the insulin pen delivery method, 24 participants began in Period 1 and 23 began in Period 2, for a total of 47 participants receiving this intervention.
|
31.9%
15/47 • Number of events 36 • Adverse events were collected from the time study treatment began through the completion of both 12-week periods of the study (up to 24 weeks). Twenty-five participants began the vial and syringe delivery method in Period 1 and 23 participants began this intervention in Period 2, resulting in 48 participants receiving this intervention. For the insulin pen delivery method, 24 participants began in Period 1 and 23 began in Period 2, for a total of 47 participants receiving this intervention.
|
Additional Information
Christopher Newton, MD
Emory University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place