Impact of Non-Tailored One-Way Automated Short Messaging Service (OASMS) on Glycemic Control in Type 2 Diabetes: A Retrospective Feasibility Study.
ABSTRACT: Short message service (SMS) is easily accessible and potentially an ideal platform for delivering patient-targeted messages. However, an effective SMS dosing strategy is not well established. Our purpose was to evaluate the impact of diabetes self-care promoting messages via non-tailored one-way automated SMS (OASMS) on glycemic control in type 2 diabetes (T2DM). The change in hemoglobin A1c (HbA1c) was compared between patients who received the service and those who did not. This retrospective quasi-experimental pre-post feasibility study was conducted at an academic medical center endocrinology clinic. English-speaking adults (?18 years) with uncontrolled T2DM (HbA1c ? 8%) were included. A total of 69 patients (intervention n = 34; control n = 35) met the inclusion criteria. The mean (±SD) baseline HbA1c values were 10.2% (±1.9%) and 9.9% (±1.7%) in the intervention and control arms, respectively. Median follow-up was 3.3 months (IQR = 3-4.2). An ANCOVA model adjusted for baseline HbA1c and age showed an estimated HbA1c reduction difference of -0.97% (95% CI, -1.73 to -0.20%, p = 0.014), favoring the intervention arm. Inverse propensity score weighting confirmed the ANCOVA results. Our study suggests that adding diabetes self-care promoting messages via non-tailored OASMS to usual care improves glycemic control in poorly controlled T2DM. Larger and longer studies are needed to evaluate different features of the non-tailored OASMS strategy.
Project description:Due to the ubiquity of mobile phones in low and middle income countries, we aimed to examine the feasibility of SMS education among diabetic patients in Egypt, and assess the impact of educational text messages, compared to traditional paper-based methods, on glycemic control and self-management behaviors.We conducted a 12-week randomized controlled trial at Misr University for Science & Technology hospital in Cairo-Egypt. Known as MUST diabetes awareness program, patients were included if they had diabetes, owned a mobile phone, and could read SMS messages or lived with someone that could read for them. Intervention patients received daily messages and weekly reminders addressing various diabetes care categories. We expected greater improvement in their glycemic control compared to controls who only received paper-based educational material. The primary outcome was the change in HbA1c, measured by the difference between endpoint and baseline values and by the number of patients who experienced at least 1% reduction from baseline to endpoint. Key secondary outcomes included blood glucose levels, body weight, treatment and medication adherence, self-efficacy, and diabetes knowledge. Data were analyzed using ANCOVA, chi-square, and t-tests.Thirty four intervention and 39 control patients completed the study. Over 12 weeks, 3880 messages were sent. Each intervention patient received 84 educational and 12 reminder messages plus one welcome message. Our primary outcome did not differ significantly (? 0.290; 95% CI -0.402 to 0.983; p?=?0.406) between groups after 3 months, demonstrating a mean drop of -0.69% and -1.05% in the control and intervention group respectively. However, 16 intervention patients achieved the targeted 1% drop versus only 6 controls, suggesting clear association between study group and 1% HbA1c reductions (chi-square?=?8.655; df?=?1; p?=?0.003). Secondary outcomes seemed in favor of intervention patients at endpoint, with considerable improvements in treatment and medication adherence, self-efficacy, and knowledge scores. Participants also indicated full satisfaction with the program.SMS education is a feasible and acceptable method for improving glycemic control and self-management behaviors among Egyptian diabetics. However, whether it is more effective than traditional paper-based methods needs further investigation.ClinicalTrials.gov NCT02868320 . Registered 9 August 2016. Retrospectively registered.
Project description:BACKGROUND:Mobile diabetes apps enable health care professionals (HCPs) to monitor patient progress, offer remote consultations, and allow more effective and informed treatment decisions between patients and HCPs. The OneTouch Reveal app aggregates data from a blood glucose meter and provides analytics to help patients and HCPs visualize glycemic trends and patterns, enabling more informed treatment and lifestyle decisions. The app also allows patients and HCPs to keep connected by exchanging text messages (short message service [SMS]) or progress reports via email. OBJECTIVE:The primary objective of our study was to assess changes in glycemic control and overall experiences of patients and HCPs using the app in conjunction with the wireless OneTouch Verio Flex blood glucose meter. METHODS:We randomly assigned 137 adults with type 1 (T1DM) or type 2 diabetes mellitus (T2DM) and a glycated hemoglobin (HbA1c) level of ?7.5% and ?11.0% to use the glucose meter alone or glucose meter plus the app for 24 weeks. The meter + app group were scheduled to receive diabetes-related text messages from their HCP every 2 weeks (total of 12 texts). Clinical measures and self-reported outcomes were assessed during face-to-face clinic visits between the participant and a diabetes nurse at baseline, week 12, and week 24. RESULTS:In 128 completed participants, HbA1c decreased after 12 and 24 weeks in both the meter-only (n=66) (0.56% and 0.55%, respectively) and meter + app groups (n=62) (0.78% and 0.67%, respectively) compared with baseline (each P<.001). The difference in HbA1c reduction between the 2 groups was not statistically significant at 12 or 24 weeks (P=.12 and P=.45, respectively). However, the decrease in HbA1c was greater in T2DM participants using the meter + app after 12 weeks (1.04%) than in T2DM participants using the meter alone (0.58%; P=.09). In addition, decrease in HbA1c in participants using the meter + app who received at least 10 diabetes-related text messages (1.05%) was significantly greater than in meter-only participants (P<.01). CONCLUSIONS:Use of the OneTouch Verio Flex glucose meter alone or in combination with the OneTouch Reveal diabetes app was associated with significant improvements in glycemic control after 12 and 24 weeks. Improvements using the app were greatest in participants with T2DM and those participants who received the highest number of HCP text messages. This study suggests that real-time availability of patient data and the ability to send personalized diabetes-related text messages can assist HCPs to improve glycemic control in patients between scheduled visits. TRIAL REGISTRATION:Clinicaltrials.gov NCT02429024; https://clinicaltrials.gov/ct2/show/NCT02429024 (Archived by WebCite at http://www.webcitation.org/6sCTDRa1l).
Project description:This randomized, controlled, open-label study conducted in Kangbuk Samsung Hospital evaluated the effectiveness, reproducibility, and durability of tailored mobile coaching (TMC) on diabetes management. The participants included 148 Korean adult policyholders with type 2 diabetes divided into the Intervention-Maintenance (I-M) group (n?=?74) and Control-Intervention (C-I) group (n?=?74). Intervention was the addition of TMC to typical diabetes care. In the 6-month phase 1, the I-M group received TMC, and the C-I group received their usual diabetes care. During the second 6-month phase 2, the C-I group received TMC, and the I-M group received only regular information messages. After the 6-month phase 1, a significant decrease (0.6%) in HbA1c levels compared with baseline values was observed in only the I-M group (from 8.1?±?1.4% to 7.5?±?1.1%, P?<?0.001 based on a paired t-test). At the end of phase 2, HbA1c levels in the C-I group decreased by 0.6% compared with the value at 6 months (from 7.9?±?1.5 to 7.3?±?1.0, P?<?0.001 based on a paired t-test). In the I-M group, no changes were observed. Both groups showed significant improvements in frequency of blood-glucose testing and exercise. In conclusion, addition of TMC to conventional treatment for diabetes improved glycemic control, and this effect was maintained without individualized message feedback.
Project description:BACKGROUND:Type 2 diabetes is a serious clinical problem in both India and the UK. Adoption of a healthy lifestyle through dietary and physical activity modification can help prevent type 2 diabetes. However, implementing lifestyle modification programmes to high risk groups is expensive and alternative cheaper methods are needed. We are using a short messaging service (SMS) programme in our study as a tool to provide healthy lifestyle advice and an aid to motivation. The aim of the study is to assess the efficacy and user acceptability of text messaging employed in this way for people with pre-diabetes (HbA1c 6.0% to ≤6.4%; 42-47 mmol/mol) in the UK and India. METHODS/DESIGN:This is a randomised, controlled trial with participants followed up for 2 years. After being screened and receiving a structured education programme for prediabetes, participants are randomised to a control or intervention group. In the intervention group, text messages are delivered 2-3 times weekly and contain educational, motivational and supportive content on diet, physical activity, lifestyle and smoking. The control group undergoes monitoring only. In India, the trial involves 5 visits after screening (0, 6, 12, 18 and 24 months). In the UK there are 4 visits after screening (0, 6, 12 and 24 months). Questionnaires (EQ-5D, RPAQ, Transtheoretical Model of Behavioural Change, and food frequency (UK)/24 h dietary recall (India)) and physical activity monitors (Actigraph GT3X+ accelerometers) are assessed at baseline and all follow-up visits. The SMS acceptability questionnaires are evaluated in all follow-up visits. The primary outcome is progression to type 2 diabetes as defined by an HbA1c of 6.5% or over(India) and by any WHO criterion(UK). Secondary outcomes are the changes in body weight, body mass index, waist circumference, blood pressure, fasting plasma glucose; lipids; proportion of participants achieving HbA1c ≤6.0%; HOMA-IR; HOMA-β; acceptability of SMS; dietary parameters; physical activity and quality of life. DISCUSSION:The study is designed to assess the efficacy of tailored text messaging in addition to standard lifestyle advice to reduce the progression from prediabetes to type 2 diabetes in the two different countries. TRIAL REGISTRATION:ClinicalTrials.gov ; NCT01570946 , 4th April 2012 (India); NCT01795833 , 21st February 2013 (UK).
Project description:Dietary therapy is the mainstay of treatment for diabetes. This study examined the effect of a low glycemic index (GI) multi-nutrient supplement, consumed in place of breakfast, on glycemic control in patients with type 2 diabetes mellitus (T2DM). A total of 71 participants were randomized at a 2:1 ratio into either a breakfast replacement group or a normal breakfast group for a 12-week interventional study. The primary outcome measure was change in hemoglobin A1c (HbA1c). Nutrition status and somatometry were studied as secondary outcomes. The breakfast replacement group displayed a -0.2% absolute reduction in HbA1c (95% CI (confidence interval), -0.38% to -0.07%, p = 0.004), while the HbA1c of the control group increased 0.3% (95% CI, 0.1% to 0.5%, p = 0.005). The baseline Mini Nutritional Assessment score for both groups was 26.0 and no significant changes occurred following intervention. However, there was a statistically significant difference in body mass index between the treatment and control groups (p = 0.032) due to the weight gain in the control group (increased 0.5 kg, 95% CI was 0.2 to 0.9, p = 0.007). These data suggest that breakfast replacement with a low GI multi-nutrient supplement can improve glycemic and weight control in T2DM.
Project description:BACKGROUND:Management of diabetes through improved glycemic control and risk factor modification can help prevent long-term complications. Much diabetes management is self-management, in which healthcare providers play a supporting role. Well-designed e-Health solutions targeting behavior change can improve a range of measures, including glycemic control, perceived health, and a reduction in hospitalizations. METHODS:The primary objective of this study is to evaluate if a mobile application designed to improve self-management among patients with type 2 diabetes (T2DM) improves glycemic control compared to usual care. The secondary objectives are to determine the effects on patient experience and health system costs; evaluate how and why the intervention worked as observed; and gain insight into considerations for system-wide scale-up. This pragmatic, randomized, wait-list-control trial will recruit adult participants from three Diabetes Education Programs in Ontario, Canada. The primary outcome is glycemic control (measured by HbA1c). Secondary outcomes include patient-reported outcomes and patient-reported experience measures, health system utilization, and intervention usability. The primary outcome will be analyzed using an ANCOVA, with continuous secondary outcomes analyzed using Poisson regression. Direct observations will be conducted of the implementation and application-specific training sessions provided to each site. Semi-structured interviews will be conducted with participants, healthcare providers, organizational leaders, and system stakeholders as part of the embedded process evaluation. Thematic analysis will be applied to the qualitative data in order to describe the relationships between (a) key contextual factors, (b) the mechanisms by which they effect the implementation of the intervention, and (c) the impact on the outcomes of the intervention, according to the principles of Realist Evaluation. DISCUSSION:The use of mobile health and virtual tools is on the rise in health care, but the evidence of their effectiveness is mixed and their evaluation is often lacking key contextual data. Results from this study will provide much needed information about the clinical and cost-effectiveness of a mobile application to improve diabetes self-management. The process evaluation will provide valuable insight into the contextual factors that influence the application effectiveness, which will inform the potential for adoption and scale. TRIAL REGISTRATION:Clinicaltrials.gov NCT02813343 . Registered on 24 June 2016 (retrospectively registered). Trial Sponsor: Ontario Telemedicine Network.
Project description:OBJECTIVE:To determine the effectiveness of a theoretically based and individually tailored, text message based, diabetes self management support intervention (SMS4BG) in adults with poorly controlled diabetes. DESIGN:Nine month, two arm, parallel randomised controlled trial. SETTING:Primary and secondary healthcare services in New Zealand. PARTICIPANTS:366 participants aged 16 years and over with poorly controlled type 1 or type 2 diabetes (HbA1c ?65 mmol/mol or 8%) randomised between June 2015 and November 2016 (n=183 intervention, n=183 control). INTERVENTIONS:The intervention group received a tailored package of text messages for up to nine months in addition to usual care. Text messages provided information, support, motivation, and reminders related to diabetes self management and lifestyle behaviours. The control group received usual care. Messages were delivered by a specifically designed automated content management system. MAIN OUTCOME MEASURES:Primary outcome measure was change in glycaemic control (HbA1c) from baseline to nine months. Secondary outcomes included change in HbA1c at three and six months, and self efficacy, diabetes self care behaviours, diabetes distress, perceptions and beliefs about diabetes, health related quality of life, perceived support for diabetes management, and intervention engagement and satisfaction at nine months. Regression models adjusted for baseline outcome, health district category, diabetes type, and ethnicity. RESULTS:The reduction in HbA1c at nine months was significantly greater in the intervention group (mean -8.85 mmol/mol (standard deviation 14.84)) than in the control group (-3.96 mmol/mol (17.02); adjusted mean difference -4.23 (95% confidence interval -7.30 to -1.15), P=0.007). Of 21 secondary outcomes, only four showed statistically significant improvements in favour of the intervention group at nine months. Significant improvements were seen for foot care behaviour (adjusted mean difference 0.85 (95% confidence interval 0.40 to 1.29), P<0.001), overall diabetes support (0.26 (0.03 to 0.50), P=0.03), health status on the EQ-5D visual analogue scale (4.38 (0.44 to 8.33), P=0.03), and perceptions of illness identity (-0.54 (-1.04 to -0.03), P=0.04). High levels of satisfaction with SMS4BG were found, with 161 (95%) of 169 participants reporting it to be useful, and 164 (97%) willing to recommend the programme to other people with diabetes. CONCLUSION:A tailored, text message based, self management support programme resulted in modest improvements in glycaemic control in adults with poorly controlled diabetes. Although the clinical significance of these results is unclear, the findings support further investigation into the use of SMS4BG and other text message based support for this patient population. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12614001232628.
Project description:An estimated 1 in 3 American adults will have diabetes by the year 2050. Nationally, South Carolina ranks 10th in cases of diagnosed diabetes compared to other states. In adults, type 2 diabetes (T2DM) accounts for approximately 90-95% of all diagnosed cases of diabetes. Clinically, provider and health system factors account for < 10% of the variance in major diabetes outcomes including hemoglobin A1c (HbA1c), lipid control, and resource use. Use of telemonitoring systems offer new opportunities to support patients with T2DM while waiting to be seen by their health care providers at actual office visits. A variety of interventions testing the efficacy of telemedicine interventions have been conducted, but the outcomes have yielded equivocal results, emphasizing the shortage of controlled, randomized trials in this area. This study provides a unique opportunity to address this gap in the literature by optimizing two strategies that have been shown to improve glycemic control, while simultaneously implementing clinical outcomes measures, using a sufficient sample size, and offering health care delivery to rural, underserved and low income communities with T2DM who are seen at Federally Qualified Health Centers (FQHCs) in coastal South Carolina.We describe a four-year prospective, randomized clinical trial, which will test the effectiveness of technology-assisted case management in low income rural adults with T2DM. Two-hundred (200) male and female participants, 18 years of age or older and with an HbA1c ? 8%, will be randomized into one of two groups: (1) an intervention arm employing the innovative FORA system coupled with nurse case management or (2) a usual care group. Participants will be followed for 6-months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that among indigent, rural adult patients with T2DM treated in FQHC's, participants randomized to the technology-assisted case management intervention will have significantly greater reduction in HbA1c at 6 months of follow-up compared to usual care.Results from this study will provide important insight into the effectiveness of technology-assisted case management intervention (TACM) for optimizing diabetes care in indigent, rural adult patients with T2DM treated in FQHC's.National Institutes of Health Clinical Trials Registry (http://ClinicalTrials.gov identifier# NCT01373489.
Project description:Objective:Patients with type 2 diabetes mellitus (T2DM) show more executive dysfunction than nondiabetics. However, how long poor glycemic control affects executive function remains unclear. Thus, we aimed to investigate the relationships in a cross-sectional study. Methods:We studied 118 T2DM outpatients (age,???60 years; excluding history of stroke, dementia and severe hypoglycemia). HbA1c values were recorded every???12 weeks for???5 years. All patients underwent verbal-fluency tests (reflecting executive function) and Mini-Mental State Examination (MMSE). The correlation between past glycemic control values and both cognitive tests scores was investigated. As markers of past glycemic control, we used average hemoglobin A1c (HbA1c) values and glycemic control variability [coefficient of variation (CV) of HbA1c values (HbA1c-CV)]. Results:Verbal-fluency tests scores correlated with HbA1c-CV, but not with average HbA1c values, after adjusting for age, years of education and sex. Verbal-fluency tests scores correlated with HbA1c-CV for the past 5 years, best compared with HbA1c-CV for past?<?5 years. MMSE scores were also related to only HbA1c-CV for the past 3 years in an adjustment model. Conclusions:Five-year HbA1c variability affected executive function in T2DM patients, but not average HbA1c values. Long-term longitudinal studies may be required.
Project description:Background: There is growing evidence that stress and sleep deprivation are involved in development of type 2 diabetes (T2DM). The latter is one of the most challenging health problems in the UAE. Therefore, the present study aimed to investigate the effects of personalized intervention on glycemic and weight control in Emirati patients with T2DM. The intervention involved assessment and modification of stress levels and sleep patterns. Methods: This was a randomized controlled study conducted on 51 Emirati patients with T2DM (age 18-60 years, body-mass index (BMI) ?25 kg/m2): those in the intervention group who completed the trial numbered 18 and those in the control group who completed the trial numbered 17. Heart-rate variability was used for real-life and long-term assessments of stress, sleep, and recovery. Body weight, BMI, HbA1c and lipid profile were included in the investigation. The National Clinical Trial identifier number is NCT03644134. Results: Percentage change in body weight was significantly greater (P<0.05) in the intervention group (-3.2±2.9) than the control group (-0.02). Percentage change in the BMI of the intervention group was -4.50±5.9, while the control group exhibited less change in BMI (-0.0003±3.3, P<0.05). In addition, a significant reduction in HbA1c was observed in the intervention group (-5.3±15.7) and an increase of 9.9±13.1 was observed in the control group (P<0.01). Conclusion: The findings of the present study show that personalized approaches that reduce stress levels, increase recovery levels, and promote healthy sleep habits play an important role in weight management and glycemic control in T2DM.