Satisfaction of Treatment Among Elderly Patients With Insulin Therapy

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01240200
• Collaborator: Sanofi (Industry)
• Enrollment: 49
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: Glargine; Device: glargine via insulin pen	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Satisfaction of Treatment Among Elderly Patients With Insulin Therapy Using Pens for a Basal Insulin Treatment (STEP IT UP a BIT)
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vial & Syringe (Period 1) / Pen (Period 2) Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.	Drug: Glargine; oral antidiabetic agents plus once daily insulin glargine via an insulin syringe; Other Names: Lantus ; Device: glargine via insulin pen; oral antidiabetic agents plus insulin glargine in a pre-filled pen; Other Names: Solostar
Experimental: Pen (Period 1) / Vial & Syringe (Period 2) Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.	Drug: Glargine; oral antidiabetic agents plus once daily insulin glargine via an insulin syringe; Other Names: Lantus ; Device: glargine via insulin pen; oral antidiabetic agents plus insulin glargine in a pre-filled pen; Other Names: Solostar

Outcome Measures

Primary Outcome Measures

1. Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score [Baseline, Week 12]

   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.

2. Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc) Score [Week 24]

   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.

Secondary Outcome Measures

1. Hemoglobin A1c (HbA1c) [Baseline, Week 12]

   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.

2. Fasting Blood Glucose [Baseline, Week 12]

   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.

3. Percent of Participants With Dosing Errors [Week 24]

   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.

4. Number of Hypoglycemic Events [Week 24]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grady Memorial Hospital	Atlanta	Georgia	United States	30303

Sponsors and Collaborators

• Emory University
• Sanofi

Investigators

• Principal Investigator: Christoper Newton, MD, Emory University SOM
• Principal Investigator: Dawn Smiley, MD, MSCR, Emory University SOM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guillermo Umpierrez, MD, Professor, Emory University
• ClinicalTrials.gov Identifier: NCT01240200
• Other Study ID Numbers: IRB00046366
• First Posted: Nov 15, 2010
• Last Update Posted: Oct 31, 2018
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Guillermo Umpierrez, MD, Professor, Emory University: diabetes; elderly; insulin injections
• Additional relevant MeSH terms: Insulin Glargine

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Vial & Syringe (Period 1) / Pen (Period 2)	Pen (Period 1) / Vial & Syringe (Period 2)
Arm/Group Description	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.	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.
Period Title: 12-week Crossover Phase - Period 1
STARTED	25	24
COMPLETED	23	23
NOT COMPLETED	2	1
Period Title: 12-week Crossover Phase - Period 1
STARTED	23	23
COMPLETED	23	23
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Vial & Syringe (Period 1) / Pen (Period 2)	Pen (Period 1) / Vial & Syringe (Period 2)	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	23	23	46
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.8 (5.8)	70.6 (4.4)	68.8 (5.4)
Sex: Female, Male (Count of Participants)
Female	17 73.9%	13 56.5%	30 65.2%
Male	6 26.1%	10 43.5%	16 34.8%

Outcome Measures

1. Primary Outcome

Title	Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the baseline and week 12 assessments.

Arm/Group Title	Vial & Syringe (Period 1) / Pen (Period 2)	Pen (Period 1) / Vial & Syringe (Period 2)
Arm/Group Description	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.	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.
Measure Participants	23	23
Baseline	28.2 (7.0)	31.5 (4.9)
Week 12	32.2 (5.2)	34.2 (2.3)

2. Primary Outcome

Title	Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc) Score
Description	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.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the week 12 and week 24 assessments.

Arm/Group Title	Vial & Syringe (Period 1) / Pen (Period 2)	Pen (Period 1) / Vial & Syringe (Period 2)
Arm/Group Description	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.	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.
Measure Participants	23	23
Mean (Standard Deviation) [units on a scale]	16.4 (2.7)	-2.3 (10.0)

3. Secondary Outcome

Title	Hemoglobin A1c (HbA1c)
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Participants with HbA1c measurements at baseline and week 12 are included in this analysis.

Arm/Group Title	Vial & Syringe (Period 1) / Pen (Period 2)	Pen (Period 1) / Vial & Syringe (Period 2)
Arm/Group Description	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.	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.
Measure Participants	23	23
Baseline	8.7 (1.1)	8.5 (1.3)
Week 12	7.6 (0.8)	7.6 (1.0)

4. Secondary Outcome

Title	Fasting Blood Glucose
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Participants with fasting blood glucose measurements at baseline and week 12 are included in this analysis.

Arm/Group Title	Vial & Syringe (Period 1) / Pen (Period 2)	Pen (Period 1) / Vial & Syringe (Period 2)
Arm/Group Description	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.	Crossover study group of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2.
Measure Participants	23	23
Baseline	159 (47)	157 (38)
Week 12	126 (19)	134 (32)

5. Secondary Outcome

Title	Percent of Participants With Dosing Errors
Description	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.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

All participants completing the study are included in this analysis (23 in dosing sequence 1 and 23 in dosing sequence 2).

Arm/Group Title	Vial & Syringe	SoloSTAR Pen
Arm/Group Description	Participants from both dosing sequences (Period 1 and Period 2) using a vial and syringe during the study to self-administer insulin glargine.	Participants from both dosing sequences (Period 1 and Period 2) using the SoloSTAR Pen during the study to self-administer insulin glargine.
Measure Participants	46	46
Number [percentage of participants]	90 391.3%	20 87%

6. Secondary Outcome

Title	Number of Hypoglycemic Events
Description	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.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

All participants completing the study are included in this analysis (23 in dosing sequence 1 and 23 in dosing sequence 2).

Arm/Group Title	Vial & Syringe	SoloSTAR Pen
Arm/Group Description	Participants from both dosing sequences (Period 1 and Period 2) using a vial and syringe during the study to self-administer insulin glargine.	Participants from both dosing sequences (Period 1 and Period 2) using the SoloSTAR Pen during the study to self-administer insulin glargine.
Measure Participants	46	46
Number [hypoglycemic events]	72	36

Adverse Events

Time Frame	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.
Arm/Group Title	Vial and Syringe		SoloSTAR Pen
Arm/Group Description	Participants, from both dosing sequences (Period 1 and Period 2), using a vial and syringe during the study to self-administer insulin.		Participants, from both dosing sequences (Period 1 and Period 2), using the SoloSTAR Pen during the study to self-administer insulin.
All Cause Mortality
	Vial and Syringe		SoloSTAR Pen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/47 (0%)
Serious Adverse Events
	Vial and Syringe		SoloSTAR Pen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/47 (0%)
Other (Not Including Serious) Adverse Events
	Vial and Syringe		SoloSTAR Pen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/48 (45.8%)		15/47 (31.9%)
Endocrine disorders
Hypoglycemia	22/48 (45.8%)	72	15/47 (31.9%)	36

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.