Satisfaction of Treatment Among Elderly Patients With Insulin Therapy
Satisfaction of Treatment Among Elderly Patients With Insulin Therapy Using Pens for a Basal Insulin Treatment (STEP IT UP a BIT)
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
-
-
Georgia
-
Atlanta, Georgia, Spojené státy, 30303
- Grady Memorial Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Males or females aged ≥60 years
- History of type 2 diabetes of >3 months duration
- Current use oral antidiabetic agents and/or diet to treat the diabetes
- A1c ≤10.0% and fasting glucose ≤300 mg/dL
- A1c ≥7.0% and/or fasting glucose ≥150 mg/dL
Exclusion Criteria:
- Subjects with a known allergy to glargine or any of its metabolites
- Subjects unwilling to self-inject insulin
- Inability to self-monitor blood glucose
- Current or previous use of insulin for more than 6 continuous months prior to study enrollment
- 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
- Mental condition rendering the subject unable to understand the nature, scope and/or possible consequences of the study
- Inability or unwillingness to provide informed consent
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
oral antidiabetic agents plus once daily insulin glargine via an insulin syringe
Ostatní jména:
oral antidiabetic agents plus insulin glargine in a pre-filled pen
Ostatní jména:
|
|
Experimentální: 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.
|
oral antidiabetic agents plus once daily insulin glargine via an insulin syringe
Ostatní jména:
oral antidiabetic agents plus insulin glargine in a pre-filled pen
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score
Časové okno: 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.
|
Baseline, Week 12
|
|
Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc) Score
Časové okno: 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.
|
Week 24
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Hemoglobin A1c (HbA1c)
Časové okno: 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.
|
Baseline, Week 12
|
|
Fasting Blood Glucose
Časové okno: 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.
|
Baseline, Week 12
|
|
Percent of Participants With Dosing Errors
Časové okno: 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.
|
Week 24
|
|
Number of Hypoglycemic Events
Časové okno: 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.
|
Week 24
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Christoper Newton, MD, Emory University SOM
- Vrchní vyšetřovatel: Dawn Smiley, MD, MSCR, Emory University SOM
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB00046366
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .