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Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes.

Greenwood DA, Blozis SA, Young HM, Nesbitt TS, Quinn CC - J. Med. Internet Res. (2015)

Bottom Line: Separate mixed-effects models were used to analyze data.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Clinical Performance Improvement Consultant, Office of Patient Experience, Quality and Clinical Effectiveness, Sutter Health, Sacramento, CA, United States. greenwd@sutterhealth.org.

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.

Trial registration: Clinicaltrials.gov NCT01715649; https://www.clinicaltrials.gov/ct2/show/NCT01715649 (Archived by WebCite at http://www.webcitation.org/6ZinLl8D0).

No MeSH data available.


Related in: MedlinePlus

Estimated A1C trajectories for the usual care and treatment groups from baseline to 6 months.
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figure4: Estimated A1C trajectories for the usual care and treatment groups from baseline to 6 months.

Mentions: Using a quadratic growth model to describe A1c over time, we tested group differences in A1c levels and the linear rates of change at baseline and at 3 and 6 months controlling for prestudy A1c. Comparisons between usual care group and treatment group suggested no difference in mean A1c or in the linear change rate at baseline. An estimated group mean A1c difference of 0.11 (t159=0.63, P=.53) at 3 months and –0.11 (t159=–0.59, P=.55) at 6 months showed no significant differences between groups. At 3 months, the usual care group decreased A1c at a mean rate of –0.35 units (t159=–4.37, P<.001). Between groups, the difference in the change rate of –0.21 (t159=–1.87, P=.06) was not significant, suggesting no difference in the change rate at 3 months. At 6 months, the change rate in A1c for the usual care group of –0.07 (t159=–1.41, P=.16) was not statistically significant, indicating no further improvement in A1c at 6 months. However, the groups differed significantly in the change rate at 6 months, with the treatment group decreasing 0.23 units faster than the usual care group (t159=–2.87, P=.005) (Table 2). Figure 4 shows A1c trajectories for groups over 6 months. Finally, the estimated acceleration rate for the usual care group was 0.14 (t159=4.07, P<.001), suggesting that the change rate increased with time. The estimated acceleration rate for the treatment group was 0.14 + (–0.013)=0.13, although the difference in this coefficient between groups was not significant (t159=–0.26, P=.80) suggesting no difference in this aspect of change in A1c over time.


Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes.

Greenwood DA, Blozis SA, Young HM, Nesbitt TS, Quinn CC - J. Med. Internet Res. (2015)

Estimated A1C trajectories for the usual care and treatment groups from baseline to 6 months.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4527012&req=5

figure4: Estimated A1C trajectories for the usual care and treatment groups from baseline to 6 months.
Mentions: Using a quadratic growth model to describe A1c over time, we tested group differences in A1c levels and the linear rates of change at baseline and at 3 and 6 months controlling for prestudy A1c. Comparisons between usual care group and treatment group suggested no difference in mean A1c or in the linear change rate at baseline. An estimated group mean A1c difference of 0.11 (t159=0.63, P=.53) at 3 months and –0.11 (t159=–0.59, P=.55) at 6 months showed no significant differences between groups. At 3 months, the usual care group decreased A1c at a mean rate of –0.35 units (t159=–4.37, P<.001). Between groups, the difference in the change rate of –0.21 (t159=–1.87, P=.06) was not significant, suggesting no difference in the change rate at 3 months. At 6 months, the change rate in A1c for the usual care group of –0.07 (t159=–1.41, P=.16) was not statistically significant, indicating no further improvement in A1c at 6 months. However, the groups differed significantly in the change rate at 6 months, with the treatment group decreasing 0.23 units faster than the usual care group (t159=–2.87, P=.005) (Table 2). Figure 4 shows A1c trajectories for groups over 6 months. Finally, the estimated acceleration rate for the usual care group was 0.14 (t159=4.07, P<.001), suggesting that the change rate increased with time. The estimated acceleration rate for the treatment group was 0.14 + (–0.013)=0.13, although the difference in this coefficient between groups was not significant (t159=–0.26, P=.80) suggesting no difference in this aspect of change in A1c over time.

Bottom Line: Separate mixed-effects models were used to analyze data.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Clinical Performance Improvement Consultant, Office of Patient Experience, Quality and Clinical Effectiveness, Sutter Health, Sacramento, CA, United States. greenwd@sutterhealth.org.

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.

Trial registration: Clinicaltrials.gov NCT01715649; https://www.clinicaltrials.gov/ct2/show/NCT01715649 (Archived by WebCite at http://www.webcitation.org/6ZinLl8D0).

No MeSH data available.


Related in: MedlinePlus