Patient-reported outcomes from a 16-week open-label, multicenter study of insulin pump therapy in patients with type 2 diabetes mellitus

Diabetes Technol Ther. 2010 Nov;12(11):901-6. doi: 10.1089/dia.2010.0075. Epub 2010 Sep 30.

Abstract

Background: This study assessed patient-reported outcomes (PRO) for patients with type 2 diabetes treated by insulin pump therapy.

Methods: This 16-week, open-label, multicenter study was conducted with adults (averaging 57 years old, 50% women, 68% white non-Hispanic, with duration of diabetes of 13 years) treated at baseline with oral antidiabetes agents (OAD) only (OAD cohort, n = 17), basal insulin with or without OAD (Basal cohort, n = 17), or multiple daily injections (MDI) with or without OAD (MDI cohort, n = 20). All diabetes medications except metformin were discontinued at baseline, and insulin pump therapy was initiated. PRO were measured at baseline and end of study using two measures of health-related quality of life (QOL)--the Diabetes Symptom Checklist-Revised (DSC-R) and the EuroQol-5 Dimensions (EQ-5D)--and a measure of treatment satisfaction--the Insulin Delivery System Rating Questionnaire (IDSRQ).

Results: The combined study population (n = 54) experienced significant reductions in DSC-R total symptoms, as well as a significant increase in the EQ-5D Visual Analog Scale score. The OAD cohort experienced no changes in any QOL measure; the Basal and MDI cohorts each experienced significant improvements in several QOL measures. The combined study population experienced significant improvements in all IDSRQ measures except treatment interference, for which change was not significant. The OAD cohort experienced significant improvements in perceived clinical efficacy and overall treatment preference; the Basal and MDI cohorts each experienced significant improvements in five of the seven IDSRQ measures.

Conclusions: Insulin pump therapy improved QOL and treatment preference in patients with type 2 diabetes.

Trial registration: ClinicalTrials.gov NCT00922649.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Cohort Studies
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Feasibility Studies
  • Female
  • Humans
  • Hypoglycemic Agents / administration & dosage*
  • Hypoglycemic Agents / therapeutic use*
  • Insulin / administration & dosage*
  • Insulin / blood
  • Insulin / therapeutic use*
  • Insulin Infusion Systems*
  • Intention to Treat Analysis
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Pilot Projects
  • Quality of Life
  • Surveys and Questionnaires
  • Treatment Outcome

Substances

  • Hypoglycemic Agents
  • Insulin

Associated data

  • ClinicalTrials.gov/NCT00922649