scholarly journals Evaluation of an mHealth-enabled hierarchical diabetes management intervention in primary care in China (ROADMAP): A cluster randomized trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (9) ◽  
pp. e1003754
Author(s):  
Weiping Jia ◽  
Puhong Zhang ◽  
Dalong Zhu ◽  
Nadila Duolikun ◽  
Hong Li ◽  
...  

Background Glycemic control remains suboptimal in developing countries due to critical system deficiencies. An innovative mobile health (mHealth)-enabled hierarchical diabetes management intervention was introduced and evaluated in China with the purpose of achieving better control of type 2 diabetes in primary care. Methods and findings A community-based cluster randomized controlled trial was conducted among registered patients with type 2 diabetes in primary care from June 2017 to July 2019. A total of 19,601 participants were recruited from 864 communities (clusters) across 25 provinces in China, and 19,546 completed baseline assessment. Moreover, 576 communities (13,037 participants) were centrally randomized to the intervention and 288 communities (6,509 participants) to usual care. The intervention was centered on a tiered care team–delivered mHealth-mediated service package, initiated by monthly blood glucose monitoring at each structured clinic visit. Capacity building and quarterly performance review strategies upheld the quality of delivered primary care. The primary outcome was control of glycated hemoglobin (HbA1c; <7.0%), assessed at baseline and 12 months. The secondary outcomes include the individual/combined control rates of blood glucose, blood pressure (BP), and low-density lipoprotein cholesterol (LDL-C); changes in levels of HbA1c, BP, LDL-C, fasting blood glucose (FBG), and body weight; and episodes of hypoglycemia. Data were analyzed using intention-to-treat (ITT) generalized estimating equation (GEE) models, accounting for clustering and baseline values of the analyzed outcomes. After 1-year follow-up, 17,554 participants (89.8%) completed the end-of-study (EOS) assessment, with 45.1% of them from economically developed areas, 49.9% from urban areas, 60.5 (standard deviation [SD] 8.4) years of age, 41.2% male, 6.0 years of median diabetes duration, HbA1c level of 7.87% (SD 1.92%), and 37.3% with HbA1c <7.0% at baseline. Compared with usual care, the intervention led to an absolute improvement in the HbA1c control rate of 7.0% (95% confidence interval [CI] 4.0% to 10.0%) and a relative improvement of 18.6% (relative risk [RR] 1.186, 95% CI 1.105 to 1.267) and an absolute improvement in the composite ABC control (HbA1c <7.0%, BP <140/80 mm Hg, and LDL-C <2.6 mmol/L) rate of 1.9% (95% CI 0.5 to 3.5) and a relative improvement of 21.8% (RR 1.218, 95% CI 1.062 to 1.395). No difference was found on hypoglycemia episode and weight gain between groups. Study limitations include noncentralized laboratory tests except for HbA1c, and caution should be exercised when extrapolating the findings to patients not registered in primary care system. Conclusions The mHealth-enabled hierarchical diabetes management intervention effectively improved diabetes control in primary care and has the potential to be transferred to other chronic conditions management in similar contexts. Trial registration Chinese Clinical Trial Registry (ChiCTR) IOC-17011325.

2010 ◽  
Vol 06 (01) ◽  
pp. 48
Author(s):  
Robert M Cuddihy ◽  

Self-monitoring of blood glucose (SMBG) with reflectance meters was heralded as a major advance in the management of diabetes and has been available to individuals with diabetes for home use since the late 1970s. This tool was put to use in the landmark Diabetes Control and Complications Trial (DCCT), which revolutionized care for individuals with type 1 diabetes, enabling these individuals to intensify their glucose control. SMBG has similar benefit in individuals with type 2 diabetes requiring insulin therapy. Its use in other individuals with type 2 diabetes treated with oral agents or non-insulin therapies is less clear. While SMBG is a potentially powerful tool to aid in the daily management of diabetes, to be used effectively, SMBG must be optimized to ensure the information derived from it can be acted on to modify physical activity, dietary intake, or medications to improve glycemic control. Recently, studies looking at this population have called into question the utility of SMBG in the management of individuals with type 2 diabetes treated with non-insulin therapies. However, these studies are lacking in the specifics of how such information was used to modify therapies. In addition to this, the lack of a universally accepted output for SMBG data significantly impedes its uptake and appropriate use by healthcare providers and patients. To maximize the effectiveness of SMBG, both patients and providers need to have a clear understanding of when and how to use SMBG data and, most importantly, act upon the data to effect a change in their diabetes management.


Endocrine ◽  
2021 ◽  
Author(s):  
Marleen Kunneman ◽  
Megan E. Branda ◽  
Jennifer L. Ridgeway ◽  
Kristina Tiedje ◽  
Carl R. May ◽  
...  

Abstract Purpose To determine the effectiveness of a shared decision-making (SDM) tool versus guideline-informed usual care in translating evidence into primary care, and to explore how use of the tool changed patient perspectives about diabetes medication decision making. Methods In this mixed methods multicenter cluster randomized trial, we included patients with type 2 diabetes mellitus and their primary care clinicians. We compared usual care with or without a within-encounter SDM conversation aid. We assessed participant-reported decisions made and quality of SDM (knowledge, satisfaction, and decisional conflict), clinical outcomes, adherence, and observer-based patient involvement in decision-making (OPTION12-scale). We used semi-structured interviews with patients to understand their perspectives. Results We enrolled 350 patients and 99 clinicians from 20 practices and interviewed 26 patients. Use of the conversation aid increased post-encounter patient knowledge (correct answers, 52% vs. 45%, p = 0.02) and clinician involvement of patients (Mean between-arm difference in OPTION12, 7.3 (95% CI 3, 12); p = 0.003). There were no between-arm differences in treatment choice, patient or clinician satisfaction, encounter length, medication adherence, or glycemic control. Qualitative analyses highlighted differences in how clinicians involved patients in decision making, with intervention patients noting how clinicians guided them through conversations using factors important to them. Conclusions Using an SDM conversation aid improved patient knowledge and involvement in SDM without impacting treatment choice, encounter length, medication adherence or improved diabetes control in patients with type 2 diabetes. Future interventions may need to focus specifically on patients with signs of poor treatment fit. Clinical trial registration ClinicalTrial.gov: NCT01502891.


2017 ◽  
Vol 12 (3) ◽  
pp. 701-708 ◽  
Author(s):  
Reid Offringa ◽  
Tong Sheng ◽  
Linda Parks ◽  
Mark Clements ◽  
David Kerr ◽  
...  

Background: Diabetes is a chronic condition that requires constant self-management. As a consequence, several software platforms have been developed to facilitate the tracking of diabetes data to improve diabetes management. Our aim was to determine the real-world glycemic benefits of a mobile diabetes management platform used by individuals with type 1 and type 2 diabetes. Methods: Mobile platform-using (n = 899) and control (n = 900) participants meeting specific minimum data criteria were randomly selected from a database of diabetes users. All results were modeled using different mixed effect generalized linear models, assigning random intercepts for each user, and adjusting the distribution assumption for each outcome. Results: Users of the mobile platform increased their frequency of blood glucose monitoring (+8.8 tests per month, 95% CI [3.4, 14.1], P < .001) and had fewer hyperglycemic events and lower average glucose levels compared to the control group. In addition, a mobile user could expect a 3.5% drop in average BG (−6.4 mg/dL, 95% CI [−2.0, −10.7], P < .001) and a 10.7% decrease in hyperglycemia ( P < .001) after 2 months. Conclusion: Users of the mobile platform tested their BG more often and demonstrated greater improvement in blood glucose compared to users who did not use the mobile platform. This supports previous studies indicating that digital technologies can enhance diabetes care in a real-world setting.


Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 941-P
Author(s):  
LEI ZHANG ◽  
YAN GU ◽  
YUXIU YANG ◽  
NA WANG ◽  
WEIGUO GAO ◽  
...  

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Alvaro Sanchez ◽  
◽  
Susana Pablo ◽  
Arturo Garcia-Alvarez ◽  
Silvia Dominguez ◽  
...  

Abstract Background The most efficient procedures to engage and guide healthcare professionals in collaborative processes that seek to optimize practice are unknown. The PREDIAPS project aims to assess the effectiveness and feasibility of different procedures to perform a facilitated interprofessional collaborative process to optimize type 2 diabetes prevention in routine primary care. Methods A type II hybrid cluster randomized implementation trial was conducted in nine primary care centers of the Basque Health Service. All centers received training on effective healthy lifestyle promotion. Headed by a local leader and an external facilitator, centers conducted a collaborative structured process—the PVS-PREDIAPS implementation strategy—to adapt the intervention and its implementation to their specific context. The centers were randomly allocated to one of two groups: one group applied the implementation strategy globally, promoting the cooperation of all health professionals from the beginning, and the other performed it sequentially, centered first on nurses, who later sought the pragmatic cooperation of physicians. The following patients were eligible for inclusion: all those aged ≥ 30 years old with at least one known cardiovascular risk factor and an impaired fasting glucose level (≥ 110-125 mg/dl) but without diabetes who attended centers during the study period. The main outcome measures concerned changes in type 2 diabetes prevention practice indicators after 12 months. Results After 12 months, 3273 eligible patients at risk of type 2 diabetes had attended their family physician at least once, and of these, 490 (15%) have been addressed by assessing their healthy lifestyles in both comparison groups. The proportion of at-risk patients receiving a personalized prescription of lifestyle change was slightly higher (8.6%; range 13.5-5.9% vs 6.8%; range 7.2-5.8%) and 2.3 times more likely (95% CI for adjusted hazard ratio, 1.38-3.94) in the sequential than in the global centers, after 8 months of the intervention program implementation period. The probability of meeting the recommended levels of physical activity and fruit and vegetable intake were four- and threefold higher after the prescription of lifestyle change than only assessment and provision of advice. The procedure of engagement in and execution of the implementation strategy does not modify the effect of prescribing healthy habits (p interaction component of intervention by group, p > 0.05). Discussion Our results show that the PVS-PREDIAPS implementation strategy manages to integrate interventions with proven efficacy in the prevention of type 2 diabetes in clinical practice in primary care. Further, they suggest that implementation outcomes were somewhat better with a sequential facilitated collaborative process focused on enhancing the autonomy and responsibility of nurses who subsequently seek a pragmatic cooperation of GPs. Trial registration Clinicaltrials.gov identifier: NCT03254979. Registered 16 August 2017—retrospectively registered.


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