A randomised trial of insulin on well-being and carer strain in elderly type 2 diabetic subjects

J Diabetes Complications. May-Jun 2004;18(3):148-54. doi: 10.1016/j.jdiacomp.2003.11.001.


Introduction: Selected tablet-treated elderly type 2 subjects with very poor glycaemic control may experience improvements in well-being after starting twice-daily insulin. In this study, the health status, mood, and treatment satisfaction of diabetic subjects with poor control on oral medication were assessed before and after being randomised to one of two insulin regimens.

Methodology: Fifty-seven type 2 subjects with poor glycaemic control (HBA(1c) 9.7%) were randomised to continue tablets (Group l), twice-daily isophane insulin (Group 2), or basal/bolus isophane/lispro insulin (Group 3). Health status, treatment satisfaction, and mood were measured at baseline, 1, 3, and 6 months.

Results: Mean HBA(1c) levels were lower in Groups 1 and 3 at 6 months (P<.02 and.03, respectively) but not Group 2 (P=.2). Mean health status scores did not differ between the groups at any time point. In Group 3, significant within-subject improvements occurred in six domains of the SF-36 at 1 month, four domains at 3 months, and six domains at 6 months. There were no significant within-subject changes in health status scores in the other groups. Mean anxiety scores improved in both Groups 1 and 3 over 6 months, and mean depression scores also improved in Group 3 during the study.

Conclusions: Small improvements in health status and mood may be associated with basal/bolus, but not twice-daily, insulin in elderly type 2 subjects. These effects may be independent of glycaemic control.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Affect / drug effects
  • Aged
  • Blood Glucose Self-Monitoring / statistics & numerical data
  • Body Mass Index
  • Body Weight
  • Brief Psychiatric Rating Scale
  • Caregivers / psychology*
  • Caregivers / statistics & numerical data
  • Cognition / drug effects
  • Cognition / physiology
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / psychology*
  • Diabetic Neuropathies / physiopathology
  • Drug Administration Schedule
  • Female
  • Glycated Hemoglobin A / chemistry
  • Glycated Hemoglobin A / drug effects
  • Health Status
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / classification
  • Hypoglycemic Agents / therapeutic use
  • Injections, Subcutaneous
  • Insulin, Isophane / administration & dosage
  • Insulin, Isophane / pharmacokinetics
  • Insulin, Isophane / therapeutic use*
  • Male
  • Myocardial Infarction / complications
  • Patient Satisfaction
  • Peripheral Nervous System Diseases
  • Personal Satisfaction*
  • United Kingdom


  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin, Isophane