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Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor–Driven Virtual Diabetes Clinic: Prospective Trial

BACKGROUND: The Onduo virtual diabetes clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote personalized lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists for medication management and prescription of real-time conti...

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Autores principales: Majithia, Amit R, Kusiak, Coco M, Armento Lee, Amy, Colangelo, Francis R, Romanelli, Robert J, Robertson, Scott, Miller, David P, Erani, David M, Layne, Jennifer E, Dixon, Ronald F, Zisser, Howard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7486672/
https://www.ncbi.nlm.nih.gov/pubmed/32856597
http://dx.doi.org/10.2196/21778
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author Majithia, Amit R
Kusiak, Coco M
Armento Lee, Amy
Colangelo, Francis R
Romanelli, Robert J
Robertson, Scott
Miller, David P
Erani, David M
Layne, Jennifer E
Dixon, Ronald F
Zisser, Howard
author_facet Majithia, Amit R
Kusiak, Coco M
Armento Lee, Amy
Colangelo, Francis R
Romanelli, Robert J
Robertson, Scott
Miller, David P
Erani, David M
Layne, Jennifer E
Dixon, Ronald F
Zisser, Howard
author_sort Majithia, Amit R
collection PubMed
description BACKGROUND: The Onduo virtual diabetes clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote personalized lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists for medication management and prescription of real-time continuous glucose monitoring (RT-CGM) devices for intermittent use. OBJECTIVE: This prospective single-arm study evaluated glycemic outcomes associated with participation in the Onduo VDC for 4 months. METHODS: Adults aged ≥18 years with T2D and a baseline glycated hemoglobin (HbA1c) of ≥8% to ≤12% were enrolled from 2 primary care centers from February 2019 to October 2019. Participants were asked to engage at ≥1 time per week with their care team and to participate in a telemedicine consultation with a clinic endocrinologist for diabetes medication review. Participants were asked to use a RT-CGM device and wear six 10-day sensors (total 60 days of sensor wear) intermittently over the course of 4 months. The primary outcome was change in HbA1c at 4 months from baseline. Other endpoints included change in weight and in RT-CGM glycemic metrics, including percent time <70, 70-180, 181-250, and >250 mg/dL. Changes in blood pressure and serum lipids at 4 months were also evaluated. RESULTS: Participants (n=55) were 57.3 (SD 11.6) years of age, body mass index 33.7 (SD 7.2), and 40% (22/55) female. HbA1c decreased significantly by 1.6% (SD 1%; P<.001). When stratified by baseline HbA1c of 8.0% to 9.0% (n=36) and >9.0% (n=19), HbA1c decreased by 1.2% (SD 0.6%; P<.001) and 2.4% (SD 1.3%; P<.001), respectively. Continuous glucose monitoring–measured (n=43) percent time in range (TIR) 70-180 mg/dL increased by 10.2% (SD 20.5%; P=.002), from 65.4% (SD 23.2%) to 75.5% (SD 22.7%), which was equivalent to a mean increase of 2.4 hours TIR per day. Percent time 181-250 mg/dL and >250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively. There was no change in percent time <70 mg/dL. Mean weight decreased by 9.0 lb (SD 10.4; P<.001). Significant improvements were also observed in systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and triglycerides (P=.04 to P=<.001). CONCLUSIONS: Participants in the Onduo VDC experienced significant improvement in HbA1c, increased TIR, decreased time in hyperglycemia, and no increase in hypoglycemia at 4 months. Improvements in other metabolic health parameters including weight and blood pressure were also observed. In conclusion, the Onduo VDC has potential to support people with T2D and their clinicians between office visits by increasing access to specialty care and advanced diabetes technology including RT-CGM. TRIAL REGISTRATION: ClinicalTrials.gov NCT03865381; https://clinicaltrials.gov/ct2/show/NCT03865381
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spelling pubmed-74866722020-09-21 Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor–Driven Virtual Diabetes Clinic: Prospective Trial Majithia, Amit R Kusiak, Coco M Armento Lee, Amy Colangelo, Francis R Romanelli, Robert J Robertson, Scott Miller, David P Erani, David M Layne, Jennifer E Dixon, Ronald F Zisser, Howard J Med Internet Res Original Paper BACKGROUND: The Onduo virtual diabetes clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote personalized lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists for medication management and prescription of real-time continuous glucose monitoring (RT-CGM) devices for intermittent use. OBJECTIVE: This prospective single-arm study evaluated glycemic outcomes associated with participation in the Onduo VDC for 4 months. METHODS: Adults aged ≥18 years with T2D and a baseline glycated hemoglobin (HbA1c) of ≥8% to ≤12% were enrolled from 2 primary care centers from February 2019 to October 2019. Participants were asked to engage at ≥1 time per week with their care team and to participate in a telemedicine consultation with a clinic endocrinologist for diabetes medication review. Participants were asked to use a RT-CGM device and wear six 10-day sensors (total 60 days of sensor wear) intermittently over the course of 4 months. The primary outcome was change in HbA1c at 4 months from baseline. Other endpoints included change in weight and in RT-CGM glycemic metrics, including percent time <70, 70-180, 181-250, and >250 mg/dL. Changes in blood pressure and serum lipids at 4 months were also evaluated. RESULTS: Participants (n=55) were 57.3 (SD 11.6) years of age, body mass index 33.7 (SD 7.2), and 40% (22/55) female. HbA1c decreased significantly by 1.6% (SD 1%; P<.001). When stratified by baseline HbA1c of 8.0% to 9.0% (n=36) and >9.0% (n=19), HbA1c decreased by 1.2% (SD 0.6%; P<.001) and 2.4% (SD 1.3%; P<.001), respectively. Continuous glucose monitoring–measured (n=43) percent time in range (TIR) 70-180 mg/dL increased by 10.2% (SD 20.5%; P=.002), from 65.4% (SD 23.2%) to 75.5% (SD 22.7%), which was equivalent to a mean increase of 2.4 hours TIR per day. Percent time 181-250 mg/dL and >250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively. There was no change in percent time <70 mg/dL. Mean weight decreased by 9.0 lb (SD 10.4; P<.001). Significant improvements were also observed in systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and triglycerides (P=.04 to P=<.001). CONCLUSIONS: Participants in the Onduo VDC experienced significant improvement in HbA1c, increased TIR, decreased time in hyperglycemia, and no increase in hypoglycemia at 4 months. Improvements in other metabolic health parameters including weight and blood pressure were also observed. In conclusion, the Onduo VDC has potential to support people with T2D and their clinicians between office visits by increasing access to specialty care and advanced diabetes technology including RT-CGM. TRIAL REGISTRATION: ClinicalTrials.gov NCT03865381; https://clinicaltrials.gov/ct2/show/NCT03865381 JMIR Publications 2020-08-28 /pmc/articles/PMC7486672/ /pubmed/32856597 http://dx.doi.org/10.2196/21778 Text en ©Amit R Majithia, Coco M Kusiak, Amy Armento Lee, Francis R Colangelo, Robert J Romanelli, Scott Robertson, David P Miller, David M Erani, Jennifer E Layne, Ronald F Dixon, Howard Zisser. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 28.08.2020. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.
spellingShingle Original Paper
Majithia, Amit R
Kusiak, Coco M
Armento Lee, Amy
Colangelo, Francis R
Romanelli, Robert J
Robertson, Scott
Miller, David P
Erani, David M
Layne, Jennifer E
Dixon, Ronald F
Zisser, Howard
Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor–Driven Virtual Diabetes Clinic: Prospective Trial
title Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor–Driven Virtual Diabetes Clinic: Prospective Trial
title_full Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor–Driven Virtual Diabetes Clinic: Prospective Trial
title_fullStr Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor–Driven Virtual Diabetes Clinic: Prospective Trial
title_full_unstemmed Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor–Driven Virtual Diabetes Clinic: Prospective Trial
title_short Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor–Driven Virtual Diabetes Clinic: Prospective Trial
title_sort glycemic outcomes in adults with type 2 diabetes participating in a continuous glucose monitor–driven virtual diabetes clinic: prospective trial
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7486672/
https://www.ncbi.nlm.nih.gov/pubmed/32856597
http://dx.doi.org/10.2196/21778
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