title: Effects of self-monitoring of glucose on distress and self-efficacy in people with non-insulin-treated Type 2 diabetes: a randomized controlled trial.
abstract: OBJECTIVE
  To investigate the effects of self-monitoring of glucose in blood or urine, on diabetes-specific distress and self-efficacy, compared with usual care in people with non-insulin-treated Type 2 diabetes mellitus.
  
  
  METHODS
  One hundred and eighty-one participants with non-insulin-treated Type 2 diabetes mellitus [diabetes duration ≥ 1 year, age 45-75 years, HbA1c ≥ 53.0 mmol/mol (7.0%), self-monitoring frequency < 3 times in the previous year] were randomly assigned to blood self-monitoring (n = 60), urine self-monitoring (n = 59) or usual care (n = 62). Primary outcomes were between-group differences in diabetes-specific distress [Problem Areas in Diabetes scale (PAID)] and self-efficacy [Confidence in Diabetes Self-Care questionnaire (CIDS-2)] after 12 months. Secondary outcomes included changes in HbA1c , treatment satisfaction and depressive symptoms.
  
  
  RESULTS
  There were no statistically significant between-group differences in changes in PAID and CIDS-2 after 12 months. Mean difference in PAID between blood monitoring and control was -2.2 [95% confidence interval (CI) -7.1 to 2.7], between urine monitoring and control was -0.9 (95% CI -4.4 to 2.5) and between blood monitoring and urine monitoring was -2.0 (95% CI -4.1 to 0.1). Mean difference in CIDS-2 between blood monitoring and control was 0.6 [95% CI (-2.0 to 2.1), between urine monitoring and control was 2.8 (95% CI -2.3 to 7.9)] and between blood monitoring and urine monitoring was -3.3 (95% CI -7.9 to 1.3). No statistically significant between-group differences in change in any of the secondary outcome measures were found.
  
  
  CONCLUSIONS
  This study did not find statistical or clinical evidence for a long-term effect of self-monitoring of glucose in blood or urine on diabetes-specific distress and self-efficacy in people with moderately controlled non-insulin-treated Type 2 diabetes mellitus. (Current Controlled Trials ISRCTN84568563).
authors.affiliation: Department of General Practice & Elderly Care Medicine, VU University Medical Center, Amsterdam, the Netherlands.
authors.forename: U L
authors.initials: UL
authors.lastname: Malanda
authors.affiliation: Department of General Practice & Elderly Care Medicine, VU University Medical Center, Amsterdam, the Netherlands.
authors.forename: S D M
authors.initials: SD
authors.lastname: Bot
authors.affiliation: Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, the Netherlands.
authors.forename: P J
authors.initials: PJ
authors.lastname: Kostense
authors.affiliation: Department of Medical Psychology, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands.
authors.forename: F J
authors.initials: FJ
authors.lastname: Snoek
authors.affiliation: Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, the Netherlands.
authors.forename: J M
authors.initials: JM
authors.lastname: Dekker
authors.affiliation: Department of General Practice & Elderly Care Medicine, VU University Medical Center, Amsterdam, the Netherlands.
authors.forename: G
authors.initials: G
authors.lastname: Nijpels
mesh_terms: D000284:Administration, Oral; D000368:Aged; D015190:Blood Glucose Self-Monitoring / Q000523:psychology*; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000523:psychology; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000523:psychology* / Q000628:therapy / Q000652:urine; D059026:Diagnostic Self Evaluation; D003927:Diet, Diabetic / Q000523:psychology; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000032:analysis; D006029:Glycosuria / Q000175:diagnosis* / Q000517:prevention & control; D006801:Humans; D006943:Hyperglycemia / Q000175:diagnosis* / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D009426:Netherlands; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D011569:Psychiatric Status Rating Scales; D020377:Self Efficacy; D013315:Stress, Psychological / Q000209:etiology / Q000517:prevention & control*
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; C517652:hemoglobin A1c protein, human