scholarly journals Improving glycemic control in patients of South Asian origin with type 2 diabetes using a digital therapeutic (Preprint)

2020 ◽  
Author(s):  
Arjun Krishnakumar ◽  
Rajeev Chawla ◽  
Aravind Sosale ◽  
Banshi Saboo ◽  
Shilpa Joshi ◽  
...  

BACKGROUND Global prevalence of type 2 diabetes (T2D), especially among South Asians, has risen alarmingly in the last decade with little improvements in glucose control. OBJECTIVE We investigated the real-world effectiveness of the Wellthy CareTM (WC) digital therapeutic in improving glycemic control among the South Asian population of Indian origin. METHODS We conducted a retrospective, real-world, observational study on 102 patients with T2D from India enrolled on a 16-week structured self-management program delivered through the WC mobile app. Patients recorded their meals, weight, physical activity, and blood sugar in the app and received coaching on self-care behaviors (healthy eating, being active, monitoring, medication adherence, problem-solving, healthy coping, and reducing risks) through structured lessons, an artificial intelligence (AI)-powered chatbot, that provided real-time feedback, and periodic, planned interactions through certified diabetes educators via voice calls and chats. The Primary outcome of the program was change in HbA1c. Secondary outcomes included, difference between the pre-and post-intervention fasting blood glucose (FBG) and postprandial blood glucose (PPBG); change in BMI and weight at the completion of 16-week program; the association between program engagement, that was measured as the total number of interactions with the health coach and the AI-powered chat-bot, and the change in HbA1c, FBG, and PPBG. RESULTS At the end of 16 weeks, the average change in HbA1c was –0.49% (95% CI −0.73 to −0.25, P < .001). Out of all the patients, 63.72% had improved HbA1c levels with the mean change being −1.16% (95% CI −1.40 to −0.92, P < .001). The mean pre-and post-intervention FBG were 145.38 mg/dl (95% CI: 135.44 to 155.33) and 134.3 mg/dl (95% CI: 122.15 to 146.54, P = .023), and PPBG was 187.84 mg/dl (95% CI: 172.47 to 203.21) and 166.36 mg/dl (95% CI: 152.83 to 179.89, P = .028). Mean change in BMI and weight was –0.47 kg/m2 (95% CI −0.22 to −0.71 kg/m2, P < 0.001), and –1.32 kg (95% CI −0.63 to −2.01 kg, P < 0.001), respectively. There was a step-wise decrease in HbA1c, FBG, and PPBG as the program engagement increased. Patients in the highest tertile of program engagement had a significantly higher reduction in HbA1c (−0.84% vs −0.06%, P = .016), FBG (−21.4 mg/dl vs −0.18 mg/dl, P = .023), and PPBG (−22.03 mg/dl vs 2.35 mg/dl, P = .0022) than those in the lowest tertile. CONCLUSIONS The WC digital therapeutic intervention is associated with improved glucose control and other health outcomes. Digital interventions could potentially help in relieving the rising diabetes burden among South Asian populations by bringing about effective behavior change and better diabetes self-management.

2020 ◽  
Vol 8 (1) ◽  
pp. e001115 ◽  
Author(s):  
Eri Wada ◽  
Takeshi Onoue ◽  
Tomoko Kobayashi ◽  
Tomoko Handa ◽  
Ayaka Hayase ◽  
...  

IntroductionThe present study aimed to evaluate the effects of flash glucose monitoring (FGM) and conventional self-monitoring of blood glucose (SMBG) on glycemic control in patients with non-insulin-treated type 2 diabetes.Research design and methodsIn this 24-week, multicenter, open-label, randomized (1:1), parallel-group study, patients with non-insulin-treated type 2 diabetes at five hospitals in Japan were randomly assigned to the FGM (n=49) or SMBG (n=51) groups and were provided each device for 12 weeks. The primary outcome was change in glycated hemoglobin (HbA1c) level, and was compared using analysis of covariance model that included baseline values and group as covariates.ResultsForty-eight participants in the FGM group and 45 in the SMBG group completed the study. The mean HbA1c levels were 7.83% (62.1 mmol/mol) in the FGM group and 7.84% (62.2 mmol/mol) in the SMBG group at baseline, and the values were reduced in both FGM (−0.43% (−4.7 mmol/mol), p<0.001) and SMBG groups (−0.30% (−3.3 mmol/mol), p=0.001) at 12 weeks. On the other hand, HbA1c was significantly decreased from baseline values in the FGM group, but not in the SMBG group at 24 weeks (FGM: −0.46% (−5.0 mmol/mol), p<0.001; SMBG: −0.17% (−1.8 mmol/mol), p=0.124); a significant between-group difference was also observed (difference −0.29% (−3.2 mmol/mol), p=0.022). Diabetes Treatment Satisfaction Questionnaire score was significantly improved, and the mean glucose levels, SD of glucose, mean amplitude of glycemic excursions and time in hyperglycemia were significantly decreased in the FGM group compared with the SMBG group.ConclusionsGlycemic control was better with FGM than with SMBG after cessation of glucose monitoring in patients with non-insulin-treated type 2 diabetes.Trial registration numberUMIN000026452, jRCTs041180082.


2020 ◽  
Author(s):  
Charlotte Summers ◽  
Simon Tobin ◽  
David Unwin

BACKGROUND Type 2 diabetes mellitus has serious health consequences, including blindness, amputation, and stroke. There is increasing evidence that type 2 diabetes may be effectively treated with a carbohydrate-reduced diet. Digital apps are increasingly used as an adjunct to traditional health care provisions to support behaviour change and remote self-management of long-term health conditions. OBJECTIVE Our objective was to evaluate the real-world 12-month outcomes of patients prescribed the Low Carb Program (LCP) digital health at a primary care NHS site, Norwood Surgery in Southport, United Kingdom. The Low Carb Program is a nutritionally focused, digitally delivered behaviour change intervention for glycemic control and weight loss for adults with prediabetes and type 2 diabetes. METHODS We evaluated the real-world, self-reported outcomes of patients referred to the Low Carb Program by doctors at an NHS GP surgery in Southport, United Kingdom. All of the NHS patients referred to the program were diagnosed with Type 2 diabetes mellitus (T2DM) or prediabetes and given the program at no cost (N=45; mean age 54.8, SD 13.2 years; 42% (19/45) women; mean glycated hemoglobin A1c (HbA1c) 56.7 mmol/mol (range 42.1mmol/mol - 96.7mmol/mol); mean body weight 89.4 kg (SD 13.8 kg). RESULTS Of the 100 people offered the program 45 participants enrolled, all of them (100%) activated their accounts and 37 (82.2%) individuals self-reported outcomes at 12-months. Of those who enrolled 45 (100%) patients completed at least 40% of the lessons, 32 (71.1%) individuals completed >9 out of 12 core lessons of the program. Glycemic control and weight loss improved, particularly for participants who completed >9 of the 12 core lessons in the program over 12-months; mean HbA1c went from 58.8 mmol/mol at baseline to 54.0 mmol/mol (4.78 mmol/mol, SD 4.60), t(31)=5.87, p<0.001) and reported an average 4.17% total body weight reduction with an average reduction of 3.85kg (SD 2.35), t(31)=9.27, p<0.001) at the 12-month follow up point. CONCLUSIONS Though the data presented here has several limitations, the use of a digital app prescribed to adults with T2DM or prediabetes in a primary care setting supporting a transition to a low carbohydrate diet appears to show significant improvements in glycaemic control and weight loss. Further research to understand more about factors affecting engagement and further positive health implications would be valuable.


2021 ◽  
Vol 6 (1) ◽  
pp. e18-e18
Author(s):  
Sara Afshari ◽  
Narges Kalhor ◽  
Mostafa Vahedian ◽  
Rasoul Shajari ◽  
Soroush Sharifimoghadam ◽  
...  

Introduction: Diabetes is one of the most common chronic diseases that severely affects the quality of life. Self-Management and glycemic control minimize the development and progression of diabetes’s complications. Objectives: We aimed to evaluate self-care behaviors and their relationship with hemoglobin A1c (HbA1c) level in patients with type 2 diabetes, using the Diabetes Self-Management Questionnaire (DSMQ). Patients and Methods: This is a cross-sectional study conducted on type 2 diabetic patients referred to the Shahid Beheshti hospital of Qom. A total of 325 patients with type-2 diabetes participate in the study. Diabetes self-management parameters were assessed using the translated (Persian) version of the DSMQ. Results: The mean score of self-management (±SD) in patients was 26.82 (±9.43). In addition, the mean HbA1c and fasting blood sugar (FBS) levels of the participants respectively were 8.35 (±1.97) and 187.25 (±77.51). There was a significant inverse correlation between self-management score metabolic control indices. (P<0.001). Health care use subscales have been best associated with better glycemic control (P<0.001) and physical activity had the least effect on it (P<0.001). Conclusion: The findings of this study revealed that there is a significant relationship between self-management indicators and control of diabetes.


2020 ◽  
Author(s):  
Mohammed Alshehri ◽  
Shaima A. Alothman ◽  
Aqeel M. Alenazi ◽  
Jason L. Rucker ◽  
Milind A. Phadnis ◽  
...  

Abstract Background: Previous studies have shown the negative impact of sleep disturbances, specifically insomnia symptoms, on glucose metabolism for people with type 2 diabetes (T2D). People with insomnia symptoms are at risk of poor glycemic control and suboptimal diabetes self-care behavior (DSCB). Investigating the impact of a safe and effective intervention for individuals with T2D and insomnia symptoms on diabetes’ health outcomes is needed. Therefore, the aim of this exploratory study is to examine the effects of Cognitive Behavioral Therapy for Insomnia (CBT-I) on glycemic control, DSCB, and fatigue. Methods: Twenty-eight participants with T2D and insomnia symptoms, after passing an eligibility criteria at a medical research center, were randomly assigned to CBT-I (n=14) or Health Education (HE; n=14). The CBT-I and HE groups received 6 weekly one-hour sessions. This Randomized Controlled Trial (RCT) used a non-inferiority framework to test the effectiveness of CBT-I. Validated assessments were administered at baseline and post-intervention to assess glycemic control, DSCB, and fatigue. A Wilcoxon signed-rank test was utilized to compare within-group changes from baseline to post-intervention. A Mann-Whitney test was utilized to measure the between-group differences. Linear regression was used to assess the association between the blood glucose level and the number of days in the CBT-I group. Results: The recruitment duration was from October 2018 to May 2019. A total of 13 participants completed the interventions in each group and are included in the final analysis. No adverse events, because of being a part of this RCT, were reported. CBT-I participants showed significantly greater improvement in glycemic control, DSCB, and fatigue. There was a significant association between the number of days in the CBT-I intervention with the blood glucose level before bedtime (B=-0.56, p=.009) and after awakening in the morning (B=-0.57, p=.007). Conclusions: This study demonstrated a clinically meaningful effect of CBT-I on glycemic control in people with T2D and insomnia symptoms. Also, CBT-I positively impacted daytime functioning, including DSCB and fatigue. Future research is needed to investigate the long-term effects of CBT-I on laboratory tests of glycemic control and to understand the underlying mechanisms of any improvements.Trial registration: Clinical Trials Registry (NCT03713996). Retrospectively registered on 22 October 2018, https://clinicaltrials.gov/ct2/show/NCT03713996


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Li Cheng ◽  
Janet W Sit ◽  
Sek-ying Chair

Introduction: The overall incidence of stroke was higher in men than women. Type 2 diabetes is found to be a risk factor for stroke. Previous prospective studies showed each 1% increase in HbA1c would be associated with 12% increase in the risk of developing a stroke. Identifying effective strategies to optimize the glycemic control of male patients with poorly controlled type 2 diabetes would be valuable for reducing the risk of stroke. This mixed-method study aims to examine how male patients with poorly controlled type 2 diabetes responded to a person-centered empowerment-based self-management intervention. Methods: Phase I study was based on a sub-group analysis of 179 male subjects with poorly controlled type 2 diabetes [with Glycated hemoglobin (HbA1c) ≥7.5%] who received a six-week empowerment-based self-management intervention (n= 93) or attentional control (n= 86), respectively. The primary outcome was HbA1c level from baseline to three-month post-intervention. Phase II study was an in-depth individual interview with the purpose to reveal how facilitating factors or barriers become apparent in the implementation of self-management practice. Integration of quantitative and qualitative data was performed to disclose a comprehensive picture of intervention effect and mechanism. Results: The pre-post HbA1c change for male subjects in the intervention group was 1.01%, which indicated a clinical significant reduction in the risk of developing stroke. At three-month post-intervention, male participants in the intervention group showed significant improvement in glycemic control (8.99% vs. 9.68%, between-group difference: 0.69±2.64, p= 0.045). Content analysis revealed that setting personally meaningful goals, making a personalized action plan, and reflecting and solution-finding were facilitating factors perceived by male subjects with poorly controlled type 2 diabetes. Two categories for barriers to optimal glycemic control were identified, including collective culture and diabetes fatalism. Conclusions: Person-centered empowerment-based intervention could facilitate male subjects with poorly controlled type 2 diabetes to actively engage in self-management activities for stroke prevention.


2020 ◽  
Author(s):  
Mohammed Alshehri ◽  
Shaima A. Alothman ◽  
Aqeel M. Alenazi ◽  
Jason L. Rucker ◽  
Milind A. Phadnis ◽  
...  

Abstract Background: Previous studies have shown the negative impact of sleep disturbances, specifically insomnia symptoms, on glucose metabolism for people with type 2 diabetes (T2D). People with insomnia symptoms are at risk of poor glycemic control and suboptimal diabetes self-care behavior (DSCB). Investigating the impact of a safe and effective intervention for individuals with T2D and insomnia symptoms on diabetes’ health outcomes is needed. Therefore, the aim of this exploratory study is to examine the effects of Cognitive Behavioral Therapy for Insomnia (CBT-I) on glycemic control, DSCB, and fatigue. Methods: Twenty-eight participants with T2D and insomnia symptoms, after passing an eligibility criteria at a medical research center, were randomly assigned to CBT-I (n=14) or Health Education (HE; n=14). The CBT-I and HE groups received 6 weekly one-hour sessions. This Randomized Controlled Trial (RCT) used a non-inferiority framework to test the effectiveness of CBT-I. Validated assessments were administered at baseline and post-intervention to assess glycemic control, DSCB, and fatigue. A Wilcoxon signed-rank test was utilized to compare within-group changes from baseline to post-intervention. A Mann-Whitney test was utilized to measure the between-group differences. Linear regression was used to assess the association between the blood glucose level and the number of days in the CBT-I group. Results: The recruitment duration was from October 2018 to May 2019. A total of 13 participants completed the interventions in each group and are included in the final analysis. No adverse events, because of being a part of this RCT, were reported. CBT-I participants showed significantly greater improvement in glycemic control, DSCB, and fatigue. There was a significant association between the number of days in the CBT-I intervention with the blood glucose level before bedtime (B=-0.56, p=.009) and after awakening in the morning (B=-0.57, p=.007). Conclusions: This study demonstrated a clinically meaningful effect of CBT-I on glycemic control in people with T2D and insomnia symptoms. Also, CBT-I positively impacted daytime functioning, including DSCB and fatigue. Future research is needed to investigate the long-term effects of CBT-I on laboratory tests of glycemic control and to understand the underlying mechanisms of any improvements.Trial registration: Clinical Trials Registry (NCT03713996). Registered 22 October 2018, https://clinicaltrials.gov/ct2/show/NCT03713996


2020 ◽  
Author(s):  
Mohammed Alshehri ◽  
Shaima A. Alothman ◽  
Aqeel M. Alenazi ◽  
Jason L. Rucker ◽  
Milind A. Phadnis ◽  
...  

Abstract Background: Previous studies have shown the negative impact of sleep disturbances, specifically insomnia symptoms, on glucose metabolism for people with type 2 diabetes (T2D). People with insomnia symptoms are at risk of poor glycemic control and suboptimal diabetes self-care behavior (DSCB). Investigating the impact of a safe and effective intervention for individuals with T2D and insomnia symptoms on diabetes’ health outcomes is needed. Therefore, the aim of this exploratory study is to examine the effects of Cognitive Behavioral Therapy for Insomnia (CBT-I) on glycemic control, DSCB, and fatigue. Methods: Twenty-eight participants with T2D and insomnia symptoms, after passing an eligibility criteria at a medical research center, were randomly assigned to CBT-I (n=14) or Health Education (HE; n=14). The CBT-I and HE groups received 6 weekly one-hour sessions. This Randomized Controlled Trial (RCT) used a non-inferiority framework to test the effectiveness of CBT-I. Validated assessments were administered at baseline and post-intervention to assess glycemic control, DSCB, and fatigue. A Wilcoxon signed-rank test was utilized to compare within-group changes from baseline to post-intervention. A Mann-Whitney test was utilized to measure the between-group differences. Linear regression was used to assess the association between the blood glucose level and the number of days in the CBT-I group. Results: The recruitment duration was from October 2018 to May 2019. A total of 13 participants completed the interventions in each group and are included in the final analysis. No adverse events, because of being a part of this RCT, were reported. CBT-I participants showed significantly greater improvement in glycemic control, DSCB, and fatigue. There was a significant association between the number of days in the CBT-I intervention with the blood glucose level before bedtime (B=-0.56, p=.009) and after awakening in the morning (B=-0.57, p=.007). Conclusions: This study demonstrated a clinically meaningful effect of CBT-I on glycemic control in people with T2D and insomnia symptoms. Also, CBT-I positively impacted daytime functioning, including DSCB and fatigue. Future research is needed to investigate the long-term effects of CBT-I on laboratory tests of glycemic control and to understand the underlying mechanisms of any improvements.Trial registration: Clinical Trials Registry (NCT03713996). Registered 22 October 2018, https://clinicaltrials.gov/ct2/show/NCT03713996


2019 ◽  
Vol 7 (3) ◽  
pp. 52 ◽  
Author(s):  
Ankur Joshi ◽  
Arun Mitra ◽  
Nikhat Anjum ◽  
Neelesh Shrivastava ◽  
Sagar Khadanga ◽  
...  

Background: Variations in blood glucose levels over a given time interval is termed as glycemic variability (GV). Higher GV is associated with higher diabetes-related complications. The current study was done with the aim of detecting the sensitivity of various GV indices among individuals with type 2 diabetes mellitus of different glycemic control status. Methods: We performed a longitudinal study among individuals with type 2 diabetes mellitus (T2DM) who were participating in a two-week diabetes self-management education (DSME) program. Participants were categorized by their HbA1c as poor (≥8%), acceptable (7%–8%), and optimal control (<7%). Continuous glucose monitoring (CGM) sensors recorded interstitial glucose every 15 min from day 1. The evaluated GV measures include standard deviation (SD), coefficient of variation (CV), mean amplitude of glycemic excursion (MAGE), continuous overlapping net glycemic action (CONGA), mean of daily difference for inter-day variation (MODD), high blood glucose index (HBGI), and low blood glucose index (LBGI). Results: A total of 41 study participants with 46347 CGM values were available for analysis. Of 41 participants, 20 (48.7%) were in the poor, 10 (24.3%) in the acceptable, and 11 (26.8%) in the optimal control group. The GV indices (SD; CV; MODD; MAGE; CONGA; HBGI) of poorly controlled (77.43; 38.02; 45.82; 216.63; 14.10; 16.62) were higher than acceptable (50.02; 39.32; 30.79; 138.01; 8.87; 5.56) and optimal (34.15; 29.46; 24.56; 126.15; 8.67; 3.13) control group. Glycemic variability was reduced in the poorly and acceptably controlled groups by the end of the 2-week period. There was a rise in LBGI in the optimally controlled group, indicating pitfalls of tight glycemic control. Conclusion: Indices of glycemic variability are useful complements, and changes in it can be demonstrated within short periods.


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