Correction: Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial.
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SUBMITTER: Wild SH
PROVIDER: S-EPMC5070826 | biostudies-literature | 2016 Oct
REPOSITORIES: biostudies-literature
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Correction: Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial.
Wild Sarah H SH Hanley Janet J Lewis Stephanie C SC McKnight John A JA McCloughan Lucy B LB Padfield Paul L PL Parker Richard A RA Paterson Mary M Pinnock Hilary H Sheikh Aziz A McKinstry Brian B
PLoS medicine 20161019 10
[This corrects the article DOI: 10.1371/journal.pmed.1002098.]. ...[more]
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Project description:BackgroundSelf-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes.Methods and findingsWe performed a randomized, parallel, investigator-blind controlled trial with centralized randomization in family practices in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin (HbA1c) >58 mmol/mol. The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group. The control group received usual care, with at least annual review and more frequent reviews for people with poor glycemic or blood pressure control. HbA1c assessed at 9 mo was the primary outcome. Intention-to-treat analyses were performed. 160 people were randomized to the intervention group and 161 to the usual care group between June 6, 2011, and July 19, 2013. HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group. The mean (SD) HbA1c at follow-up was 63.0 (15.5) mmol/mol in the intervention group and 67.8 (14.7) mmol/mol in the usual care group. For primary analysis, adjusted mean HbA1c was 5.60 mmol/mol / 0.51% lower (95% CI 2.38 to 8.81 mmol/mol/ 95% CI 0.22% to 0.81%, p = 0·0007). For secondary analyses, adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower (95% CI 0.56-5.56 mmHg, p = 0.017) and mean ambulatory diastolic blood pressure was 2.17 mmHg lower (95% CI 0.62-3.72, p = 0.006) among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata. No significant differences were identified between groups in weight, treatment pattern, adherence to medication, or quality of life in secondary analyses. There were few adverse events and these were equally distributed between the intervention and control groups. In secondary analysis, there was a greater number of telephone calls between practice nurses and patients in the intervention compared with control group (rate ratio 7.50 (95% CI 4.45-12.65, p < 0.0001) but no other significant differences between groups in use of health services were identified between groups. Key limitations include potential lack of representativeness of trial participants, inability to blind participants and health professionals, and uncertainty about the mechanism, the duration of the effect, and the optimal length of the intervention.ConclusionsSupported telemonitoring resulted in clinically important improvements in control of glycaemia in patients with type 2 diabetes in family practice. Current Controlled Trials, registration number ISRCTN71674628.Trial registrationCurrent Controlled Trials ISRCTN 71674628.
| S-EPMC4961438 | biostudies-literature
Project description:BackgroundConnected devices that allow people with diabetes to monitor their blood glucose levels remotely with data visualization have been shown to improve self-care behavior in diabetes management. However, their effectiveness and usability for a low-middle-income, racially diverse population are unknown.ObjectiveThis study aims to evaluate the effects of remote telemonitoring with team-based management on people with uncontrolled type 2 diabetes.DesignThis was a pragmatic 52-week cluster-randomized controlled study among 11 primary care government practices in Malaysia.ParticipantsPeople with type 2 diabetes aged 18 and above, who had hemoglobin A1c ??7.5% but less than 11.0% within the past 3 months and resided in the state of Selangor.InterventionThe intervention group received home gluco-telemonitors and transmitted glucose data to a care team who could adjust therapy accordingly. The team also facilitated self-management by supporting participants to improve medication adherence, and encourage healthier lifestyle and use of resources to reduce risk factors. Usual care group received routine healthcare service.Main measureThe primary outcome was the change in HbA1c at 24 weeks and 52 weeks. Secondary outcomes included change in fasting plasma glucose, blood pressure, lipid levels, health-related quality of life, and diabetes self-efficacy.ResultsA total of 240 participants were recruited in this study. The telemonitoring group reported larger improvements in glycemic control compared with control at the end of study (week 24, -?0.05%; 95% CI -?0.10 to 0.00%) and at follow-up (week 52, -?0.03%; -?0.07 to 0.02%, p?=?0.226). Similarly, no differences in other secondary outcomes were observed, including the number of adverse events and health-related quality of life.ConclusionThis study indicates that there is limited benefit of replacing telemedicine with the current practice of self-monitoring of blood glucose. Further innovative methods to improve patient engagement in diabetes care are needed.Trial registrationClinicalTrials.gov identifier: NCT02466880.
| S-EPMC6957608 | biostudies-literature
Project description:BackgroundHealth outcomes for people treated for type 2 diabetes could be substantially improved in sub-Saharan Africa. Failure to take medicine regularly to treat diabetes has been identified as a major problem. Resources to identify and support patients who are not making the best use of medicine in low- and middle-income settings are scarce. Mobile phones are widely available in these settings, including among people with diabetes; linked technologies, such as short message service (SMS) text messaging, have shown promise in delivering low-cost interventions efficiently. However, evidence showing that these interventions will work when carried out at a larger scale and measuring the extent to which they will improve health outcomes when added to usual care is limited.ObjectiveThe objective of this trial is to test the effectiveness of sending brief, automated SMS text messages for improving health outcomes and medication adherence in patients with type 2 diabetes compared to an active control.MethodsWe will carry out a randomized trial recruiting from clinics in two contrasting settings in sub-Saharan Africa: Cape Town, South Africa, and Lilongwe, Malawi. Intervention messages will advise people about the benefits of their diabetes treatment and offer motivation and encouragement around lifestyle and use of medication. We allocated patients, using randomization with a minimization algorithm, to receive either three to four intervention messages per week or non-health-related messages every 6 weeks. We will follow up with participants for 12 months, measuring important risk factors for poor health outcomes and complications in diabetes. This will enable us to estimate potential health benefits, including the primary outcome of hemoglobin A1c (HbA1c) levels as a marker for long-term blood glucose control and a secondary outcome of blood pressure control. We will record the costs of performing these activities and estimate cost-effectiveness. We will also use process evaluation to capture the collection of medication and assess the reception of the intervention by participants and health care workers.ResultsRecruitment to the trial began in September 2016 and follow-up of participants was completed in October 2018. Data collection from electronic health records and other routinely collected sources is continuing. The database lock is anticipated in June 2019, followed by analysis and disclosing of group allocation.ConclusionsThe knowledge gained from this study will have wide applications and advance the evidence base for effectiveness of mobile phone-based, brief text messaging on clinical outcomes and in large-scale, operational settings. It will provide evidence for cost-effectiveness and acceptability that will further inform policy development and decision making. We will work with a wide network that includes patients, clinicians, academics, industry, and policy makers to help us identify opportunities for informing people about the work and raise awareness of what is being developed and studied.Trial registrationISRCTN Registry ISRCTN70768808; http://www.isrctn.com/ISRCTN70768808 (Archived by WebCite at http://www.webcitation.org/786316Zqk).International registered report identifier (irrid)DERR1-10.2196/12377.
| S-EPMC6592392 | biostudies-literature
Project description:OBJECTIVE:Patient self-management support may be augmented by using home-based technologies that generate data points that providers can potentially use to make more timely changes in the patients' care. The purpose of this study was to evaluate the effectiveness of short-term targeted use of remote data transmission on treatment outcomes in patients with diabetes who had either out-of-range hemoglobin A1c (A1c) and/or blood pressure (BP) measurements. MATERIALS AND METHODS:A single-center randomized controlled clinical trial design compared in-home monitoring (n=55) and usual care (n=53) in patients with type 2 diabetes and hypertension being treated in primary care clinics. Primary outcomes were A1c and systolic BP after a 12-week intervention. RESULTS:There were no significant differences between the intervention and control groups on either A1c or systolic BP following the intervention. CONCLUSIONS:The addition of technology alone is unlikely to lead to improvements in outcomes. Practices need to be selective in their use of telemonitoring with patients, limiting it to patients who have motivation or a significant change in care, such as starting insulin. Attention to the need for effective and responsive clinic processes to optimize the use of the additional data is also important when implementing these types of technology.
| S-EPMC3934666 | biostudies-literature
Project description:OBJECTIVE We compared the short-term efficacy of home telemonitoring coupled with active medication management by a nurse practitioner with a monthly care coordination telephone call on glycemic control in veterans with type 2 diabetes and entry A1C > or =7.5%. RESEARCH DESIGN AND METHODS Veterans who received primary care at the VA Pittsburgh Healthcare System from June 2004 to December 2005, who were taking oral hypoglycemic agents and/or insulin for > or =1 year, and who had A1C > or =7.5% at enrollment were randomly assigned to either active care management with home telemonitoring (ACM+HT group, n = 73) or a monthly care coordination telephone call (CC group, n = 77). Both groups received monthly calls for diabetes education and self-management review. ACM+HT group participants transmitted blood glucose, blood pressure, and weight to a nurse practitioner using the Viterion 100 TeleHealth Monitor; the nurse practitioner adjusted medications for glucose, blood pressure, and lipid control based on established American Diabetes Association targets. Measures were obtained at baseline, 3-month, and 6-month visits. RESULTS Baseline characteristics were similar in both groups, with mean A1C of 9.4% (CC group) and 9.6% (ACM+HT group). Compared with the CC group, the ACM+HT group demonstrated significantly larger decreases in A1C at 3 months (1.7 vs. 0.7%) and 6 months (1.7 vs. 0.8%; P < 0.001 for each), with most improvement occurring by 3 months. CONCLUSIONS Compared with the CC group, the ACM+HT group demonstrated significantly greater reductions in A1C by 3 and 6 months. However, both interventions improved glycemic control in primary care patients with previously inadequate control.
| S-EPMC2827492 | biostudies-literature
Project description:BackgroundIndependent supported housing (ISH)-services to support independent housing are recommended by current guidelines. However, there is little evidence of ISH models for non-homeless people with severe mental illness (SMI). The aim of this study was to examine the effectiveness of ISH by comparing the clinical outcomes of a newly implemented ISH service with regular housing and support services.MethodsA total of 58 adults with a broad spectrum of mental disorders experiencing housing problems were randomly assigned to either the intervention group (IG) with the possibility to use the ISH service in Zurich providing targeted, individual and flexible support for housing problems or to the control group (CG) with regular housing and support services currently available (trial registration at ClinicalTrials.gov: NCT03815604).ResultsAfter 12 months, almost all participants of the IG were able to live independently and need for inpatient treatment could be significantly reduced. Service utilization varied between 2 and 79 h. In the CG, 70% of the participants wanted to join a waiting list for the ISH service. The results indicated that IHS was comparable to regular housing and support services in terms of social inclusion and other social and clinical outcomes such as quality of life, capabilities, needs, mental state and functioning (p's > 0.05). The costs of service utilization were on average 115 Swiss Francs (about 124 USD) per participant per month.ConclusionsISH is an effective service in housing rehabilitation in terms of social and clinical outcomes and costs. ISH is strongly preferred by service users. In line with the UN Convention on the Rights of Persons with Disabilities, access to ISH services for non-homeless people with SMI should be improved.Clinical trial registrationClinicalTrials.gov, identifier: NCT03815604, December 04, 2019.
| S-EPMC8814620 | biostudies-literature
Project description:ObjectiveIt is unknown whether computer-generated, patient-tailored feedback leads to improvements in glycemic control in people with type 2 diabetes.Research design and methodsWe recruited people with type 2 diabetes aged ≥ 40 years with a glycated hemoglobin (A1C) ≥ 7%, living in Hamilton, Canada, who were enrolled in a community-based program (Diabetes Hamilton) that provided regular evidence-based information and listings of community resources designed to facilitate diabetes self-management. After completing a questionnaire, participants were randomly allocated to either receive or not receive periodic computer-generated, evidence-based feedback on the basis of their questionnaire responses and designed to facilitate improved glycemic control and diabetes self-management. The primary outcome was a change in A1C after 1 year.ResultsA total of 465 participants (50% women, mean age 62 years, and mean A1C 7.83%) were randomly assigned, and 12-month A1C values were available in 96% of all participants, at which time the A1C level had decreased by an absolute amount of 0.24 and 0.15% in the intervention and control groups, respectively. The difference in A1C reduction for the intervention versus control group was 0.09% (95% CI -0.08 to 0.26; P = 0.3). No between-group differences in measures of quality of life, diabetes self-management behaviors, or clinical outcomes were observed.ConclusionsProviding computer-generated tailored feedback to registrants of a generic, community-based program that supports diabetes self-management does not lead to lower A1C levels or a better quality of life than participation in the community-based program (augmented by periodic A1C testing) alone.
| S-EPMC3142042 | biostudies-literature
Project description:This study aimed to investigate the effect of patient engagement in self-monitoring with a telemonitoring device on glycemic control among patients with type 2 diabetes. We conducted a subanalysis of the telemonitoring device study in Kaiser Permanente Northern California members. We divided the telemonitoring group into 53 frequent and 54 infrequent users based on self-monitoring of blood glucose (SMBG) frequency of the first 6 weeks. The frequency of SMBG transmitted from the telemonitoring device was examined over 24 weeks. Clinic and laboratory tests were collected at baseline, 6 weeks and 6 months. There was no significant difference in baseline HbA1c level between the two groups. After 6 months, change in HbA1c was -2.4 ± 1.6% among frequent users and -1.5 ± 1.5% among infrequent users (p = 0.003). The proportion of patients achieving target HbA1C level at 6 months was significantly higher among frequent users than among infrequent users. An increased frequency of SMBG was significantly correlated with a reduction in HbA1c at 6 months. In conclusion, initial active engagement in self-monitoring with a telemonitoring device could provide incremental improvement of glycemic control over 6 months.
| S-EPMC5478652 | biostudies-literature
Project description:ObjectiveOn June 18 2018, Japan experienced the North Osaka Earthquake. The shaking intensity was recorded as level 6 of the Japan Meteorological Agency Seismic Intensity Scale. Despite the severe shaking, damages of lifelines and transportation networks were limited, and they were completely recovered within several days. We investigated whether the glycemic control in patients with diabetes was deteriorated over months after the earthquake.MethodsWe retrospectively analyzed diabetic outpatients attending the department of Metabolic Medicine, Osaka University Hospital, close to the epicenter of the earthquake, in 2018 (n = 1940), and those in 2017 (n = 1908) as a control. Whether glycated hemoglobin (HbA1c) levels were elevated after the earthquake, and whether the post-earthquake HbA1c elevation was more prevalent in areas with a higher seismic intensity were investigated using the mixed effects model.ResultsCompared to the same periods in 2017, mean HbA1c levels in 2018 were significantly higher 3-6 months after the earthquake (P < 0.05). The risk of HbA1c ≥ 7.0% was 1.6 (95% confidence interval 1.2-2.2) and 1.7 (1.2-2.4) times higher 3-4 and 5-6 months after the earthquake. Furthermore, the proportion of HbA1c deterioration after the earthquake was higher in areas with a higher seismic intensity (P for trend = 0.025).ConclusionGlycemic control was significantly deteriorated over months after the 2018 North Osaka Earthquake despite limited damage of lifelines and transportation networks. The deterioration was more prevalent in areas with a high seismic intensity.
| S-EPMC7790924 | biostudies-literature
Project description:ImportanceThe levels of glycemic control associated with the lowest risk of dementia in people with type 2 diabetes are unknown. This knowledge is critical to inform patient-centered glycemic target setting.ObjectiveTo examine the associations between cumulative exposure to various ranges of glycated hemoglobin (HbA1c) concentrations with dementia risk across sex and racial and ethnic groups and the association of current therapeutic glycemic targets with dementia risk.Design, setting, and participantsThis cohort study included members of the Kaiser Permanente Northern California integrated health care system with type 2 diabetes who were aged 50 years or older during the study period from January 1, 1996, to September 30, 2015. Individuals with fewer than 2 HbA1c measurements during the study period, prevalent dementia at baseline, or less than 3 years of follow-up were excluded. Data were analyzed from February 2020 to January 2023.ExposuresTime-updated cumulative exposure to HbA1c thresholds. At each HbA1c measurement, participants were categorized based on the percentage of their HbA1c measurements that fell into the following categories: less than 6%, 6% to less than 7%, 7% to less than 8%, 8% to less than 9%, 9% to less than 10%, and 10% or more of total hemoglobin (to convert percentage of total hemoglobin to proportion of total hemoglobin, multiply by 0.01).Main outcomes and measuresDementia diagnosis was identified using International Classification of Diseases, Ninth Revision codes from inpatient and outpatient encounters. Cox proportional hazards regression models estimated the association of time-varying cumulative glycemic exposure with dementia, adjusting for age, race and ethnicity, baseline health conditions, and number of HbA1c measurements.ResultsA total of 253 211 participants were included. The mean (SD) age of participants was 61.5 (9.4) years, and 53.1% were men. The mean (SD) duration of follow-up was 5.9 (4.5) years. Participants with more than 50% of HbA1c measurements at 9% to less than 10% or 10% or more had greater risk of dementia compared with those who had 50% or less of measurements in those categories (HbA1c 9% to <10%: adjusted hazard ratio [aHR], 1.31 [95% CI, 1.15-1.51]; HbA1c≥10%: aHR, 1.74 [95% CI, 1.62-1.86]). By contrast, participants with more than 50% of HbA1c concentrations less than 6%, 6% to less than 7%, or 7% to less than 8% had lower risk of dementia (HbA1c<6%: aHR, 0.92 [95% CI, 0.88-0.97]; HbA1c 6% to <7%: aHR, 0.79 [95% CI, 0.77-0.81]; HbA1c 7% to <8%: aHR, 0.93 [95% CI, 0.89-0.97]).Conclusions and relevanceIn this study dementia risk was greatest among adults with cumulative HbA1c concentrations of 9% or more. These results support currently recommended relaxed glycemic targets for older people with type 2 diabetes.
| S-EPMC10111232 | biostudies-literature