title: Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes.
abstract: BACKGROUND
  Type 2 diabetes mellitus is a worldwide challenge. Practice guidelines promote structured self-monitoring of blood glucose (SMBG) for informing health care providers about glycemic control and providing patient feedback to increase knowledge, self-efficacy, and behavior change. Paired glucose testing—pairs of glucose results obtained before and after a meal or physical activity—is a method of structured SMBG. However, frequent access to glucose data to interpret values and recommend actions is challenging. A complete feedback loop—data collection and interpretation combined with feedback to modify treatment—has been associated with improved outcomes, yet there remains limited integration of SMBG feedback in diabetes management. Incorporating telehealth remote monitoring and asynchronous electronic health record (EHR) feedback from certified diabetes educators (CDEs)—specialists in glucose pattern management—employ the complete feedback loop to improve outcomes.
  
  
  OBJECTIVE
  The purpose of this study was to evaluate a telehealth remote monitoring intervention using paired glucose testing and asynchronous data analysis in adults with type 2 diabetes. The primary aim was change in glycated hemoglobin (A(1c))—a measure of overall glucose management—between groups after 6 months. The secondary aims were change in self-reported Summary of Diabetes Self-Care Activities (SDSCA), Diabetes Empowerment Scale, and Diabetes Knowledge Test.
  
  
  METHODS
  A 2-group randomized clinical trial was conducted comparing usual care to telehealth remote monitoring with paired glucose testing and asynchronous virtual visits. Participants were aged 30-70 years, not using insulin with A1c levels between 7.5% and 10.9% (58-96 mmol/mol). The telehealth remote monitoring tablet computer transmitted glucose data and facilitated a complete feedback loop to educate participants, analyze actionable glucose data, and provide feedback. Data from paired glucose testing were analyzed asynchronously using computer-assisted pattern analysis and were shared with patients via the EHR weekly. CDEs called participants monthly to discuss paired glucose testing trends and treatment changes. Separate mixed-effects models were used to analyze data.
  
  
  RESULTS
  Participants (N=90) were primarily white (64%, 56/87), mean age 58 (SD 11) years, mean body mass index 34.1 (SD 6.7) kg/m2, with diabetes for mean 8.2 (SD 5.4) years, and a mean A(1c) of 8.3% (SD 1.1; 67 mmol/mol). Both groups lowered A(1c) with an estimated average decrease of 0.70 percentage points in usual care group and 1.11 percentage points in the treatment group with a significant difference of 0.41 percentage points at 6 months (SE 0.08, t159=-2.87, P=.005). Change in medication (SE 0.21, t157=-3.37, P=.009) was significantly associated with lower A(1c) level. The treatment group significantly improved on the SDSCA subscales carbohydrate spacing (P=.04), monitoring glucose (P=.001), and foot care (P=.02).
  
  
  CONCLUSIONS
  An eHealth model incorporating a complete feedback loop with telehealth remote monitoring and paired glucose testing with asynchronous data analysis significantly improved A(1c) levels compared to usual care.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01715649; https://www.clinicaltrials.gov/ct2/show/NCT01715649 (Archived by WebCite at http://www.webcitation.org/6ZinLl8D0).
authors.affiliation: Clinical Performance Improvement Consultant, Office of Patient Experience, Quality and Clinical Effectiveness, Sutter Health, Sacramento, CA, United States. greenwd@sutterhealth.org.
authors.forename: Deborah A
authors.identifier: http://orcid.org/0000-0002-7603-4624
authors.initials: DA
authors.lastname: Greenwood
authors.forename: Shelley A
authors.identifier: http://orcid.org/0000-0002-8272-3258
authors.initials: SA
authors.lastname: Blozis
authors.forename: Heather M
authors.identifier: http://orcid.org/0000-0002-1691-3993
authors.initials: HM
authors.lastname: Young
authors.forename: Thomas S
authors.identifier: http://orcid.org/0000-0001-5916-9810
authors.initials: TS
authors.lastname: Nesbitt
authors.forename: Charlene C
authors.identifier: http://orcid.org/0000-0002-6066-2984
authors.initials: CC
authors.lastname: Quinn
mesh_terms: D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000379:methods*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D057286:Electronic Health Records / Q000706:statistics & numerical data*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010358:Patient Participation; D012648:Self Care; D017216:Telemedicine / Q000379:methods*
chemical_list: D006442:Glycated Hemoglobin
keywords: blood glucose self-monitoring; diabetes mellitus, type 2; eHealth; electronic health records; health records, personal; hemoglobin A1c, glycosylated; monitoring, physiologic; patient participation; remote consultation; self-care; telehealth