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Satisfaction of Treatment Among Elderly Patients With Insulin Therapy

2 octobre 2018 mis à jour par: Guillermo Umpierrez, MD, Emory University

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

49

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Georgia
      • Atlanta, Georgia, États-Unis, 30303
        • Grady Memorial Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

60 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Médicament: Glargine
oral antidiabetic agents plus once daily insulin glargine via an insulin syringe
Autres noms:
  • Lantus
Dispositif: glargine via insulin pen
oral antidiabetic agents plus insulin glargine in a pre-filled pen
Autres noms:
  • Solostar
Expérimental: 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.
Médicament: Glargine
oral antidiabetic agents plus once daily insulin glargine via an insulin syringe
Autres noms:
  • Lantus
Dispositif: glargine via insulin pen
oral antidiabetic agents plus insulin glargine in a pre-filled pen
Autres noms:
  • Solostar

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Hemoglobin A1c (HbA1c)
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Emory University

Collaborateurs

Sanofi

Les enquêteurs

  • Chercheur principal: Christoper Newton, MD, Emory University SOM
  • Chercheur principal: Dawn Smiley, MD, MSCR, Emory University SOM

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2011

Achèvement primaire (Réel)

1 août 2012

Achèvement de l'étude (Réel)

1 décembre 2012

Dates d'inscription aux études

Première soumission

9 novembre 2010

Première soumission répondant aux critères de contrôle qualité

10 novembre 2010

Première publication (Estimation)

15 novembre 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

31 octobre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 octobre 2018

Dernière vérification

1 octobre 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB00046366

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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