title: A novel telemonitoring device for improving diabetes control: protocol and results from a randomized clinical trial.
abstract: BACKGROUND
  Telemedicine is one approach to managing patients with chronic illness. Several telephone-based monitoring studies of diabetes patients have shown improved glycosylated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL) levels. The purpose of this study was to evaluate an investigational in-home telemetry device for improving glucose and BP control over 6 months for patients with type 2 diabetes. The device was used to transmit weekly blood glucose, weight, and BP readings to a diabetes care manager.
  
  
  METHODS
  We conducted a two-arm, parallel-comparison, single-blind, randomized controlled trial among Kaiser Permanente Northern California members 18-75 years old with type 2 diabetes mellitus and entry HbA1c levels between 7.5% and 10.0%. Participants were randomly assigned to either the telemonitoring arm or the usual care arm.
  
  
  RESULTS
  We observed very small, nonsignificant changes in fructosamine (telemonitoring, -54.9 μmol; usual care, -59.4 μmol) and systolic BP (telemonitoring, -6.3 mm Hg; usual care, -3.2 mm Hg) from baseline to 6 weeks in both groups. At 6 months, we observed no significant intergroup differences in change from baseline for HbA1c, fructosamine, or self-efficacy. However, LDL cholesterol in the telemonitoring arm decreased more than in the usual care arm (-17.1 mg/dL versus -5.4 mg/dL; P=0.045).
  
  
  CONCLUSIONS
  Although HbA1c improved significantly over 6 months in both groups, the difference in improvement between the groups was not significant. This lack of significance may be due to the relatively healthy status of the volunteers in our study and to the high level of care provided by the care managers in the Santa Rosa, CA clinic. Further study in subgroups of less healthy diabetes patients is recommended.
authors.affiliation: 1 Kaiser Permanente Division of Research , Oakland, California.
authors.forename: Alice R
authors.initials: AR
authors.lastname: Pressman
authors.forename: Linda
authors.initials: L
authors.lastname: Kinoshita
authors.forename: Susan
authors.initials: S
authors.lastname: Kirk
authors.forename: Gina Monraz
authors.initials: GM
authors.lastname: Barbosa
authors.forename: Cathy
authors.initials: C
authors.lastname: Chou
authors.forename: Jerome
authors.initials: J
authors.lastname: Minkoff
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis*; D001794:Blood Pressure; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000628:therapy; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D020377:Self Efficacy; D016037:Single-Blind Method; D017216:Telemedicine / Q000379:methods*; D013686:Telemetry / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin