DreamTel; Diabetes risk evaluation and management tele-monitoring study protocol.
ABSTRACT: The rising prevalence of type 2 diabetes underlines the importance of secondary strategies for the prevention of target organ damage. While access to diabetes education centers and diabetes intensification management has been shown to improve blood glucose control, these services are not available to all that require them, particularly in rural and northern areas. The provision of these services through the Home Care team is an advance that can overcome these barriers. Transfer of blood glucose data electronically from the home to the health care provider may improve diabetes management.The study population will consist of patients with type 2 diabetes with uncontrolled A1c levels living on reserve in the Battlefords region of Saskatchewan, Canada. This pilot study will take place over three phases. In the first phase over three months the impact of the introduction of the Bluetooth enabled glucose monitor will be assessed. In the second phase over three months, the development of guidelines based treatment algorithms for diabetes intensification will be completed. In the third phase lasting 18 months, study subjects will have diabetes intensification according to the algorithms developed.The first phase will determine if the use of the Bluetooth enabled blood glucose devices which can transmit results electronically will lead to changes in A1c levels. It will also determine the feasibility of recruiting subjects to use this technology. The rest of the Diabetes Risk Evaluation and Management Tele-monitoring (DreamTel) study will determine if the delivery of a diabetes intensification management program by the Home Care team supported by the Bluetooth enabled glucose meters leads to improvements in diabetes management.Protocol NCT00325624.
Project description:To evaluate an online disease management system supporting patients with uncontrolled type 2 diabetes.Engaging and Motivating Patients Online With Enhanced Resources for Diabetes was a 12-month parallel randomized controlled trial of 415 patients with type 2 diabetes with baseline glycosylated hemoglobin (A1C) values ?7.5% from primary care sites sharing an electronic health record. The intervention included: (1) wirelessly uploaded home glucometer readings with graphical feedback; (2) comprehensive patient-specific diabetes summary status report; (3) nutrition and exercise logs; (4) insulin record; (5) online messaging with the patient's health team; (6) nurse care manager and dietitian providing advice and medication management; and (7) personalized text and video educational 'nuggets' dispensed electronically by the care team. A1C was the primary outcome variable.Compared with usual care (UC, n=189), patients in the intervention (INT, n=193) group had significantly reduced A1C at 6 months (-1.32% INT vs -0.66% UC; p<0.001). At 12 months, the differences were not significant (-1.14% INT vs -0.95% UC; p=0.133). In post hoc analysis, significantly more INT patients had improved diabetes control (>0.5% reduction in A1C) than UC patients at 12 months (69.9 (95% CI 63.2 to 76.5) vs 55.4 (95% CI 48.4 to 62.5); p=0.006).A nurse-led, multidisciplinary health team can manage a population of diabetic patients in an online disease management program. INT patients achieved greater decreases in A1C at 6 months than UC patients, but the differences were not sustained at 12 months. More INT than UC patients achieved improvement in A1C (>0.5% decrease). Trial registered in clinical trials.gov: #NCT00542204.
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.
Project description:<h4>Background</h4>It has been established that careful diabetes self-management is essential in avoiding chronic complications that compromise health. Disciplined diet control and regular exercise are the keys for the type 2 diabetes self-management. An ability to maintain one's blood glucose at a relatively flat level, not fluctuating wildly with meals and hypoglycemic medical intervention, would be the goal for self-management. Hemoglobin A1c (HbA1c or simply A1c) is a measure of a long-term blood plasma glucose average, a reliable index to reflect one's diabetic condition. A simple regimen that could reduce the elevated A1c levels without altering much of type 2 diabetic patients' daily routine denotes a successful self-management strategy.<h4>Methods</h4>A relatively simple model that relates the food impact on blood glucose excursions for type 2 diabetes was studied. Meal is treated as a bolus injection of glucose. Medical intervention of hypoglycaemic drug or injection, if any, is lumped with secreted insulin as a damping factor. Lunch was used for test meals. The recovery period of a blood glucose excursion returning to the pre-prandial level, the maximal reach, and the area under the excursion curve were used to characterize one's ability to regulate glucose metabolism. A case study is presented here to illustrate the possibility of devising an individual-based self-management regimen.<h4>Results</h4>Results of the lunch study for a type 2 diabetic subject indicate that the recovery time of the post-prandial blood glucose level can be adjusted to 4 hours, which is comparable to the typical time interval for non-diabetics: 3 to 4 hours. A moderate lifestyle adjustment of light supper coupled with morning swimming of 20 laps in a 25 m pool for 40 minutes enabled the subject to reduce his A1c level from 6.7 to 6.0 in six months and to maintain this level for the subsequent six months.<h4>Conclusions</h4>The preliminary result of this case study is encouraging. An individual life-style adjustment can be structured from the extracted characteristics of the post-prandial blood glucose excursions. Additional studies are certainly required to draw general applicable guidelines for lifestyle adjustments of type 2 diabetic patients.
Project description:To determine the effectiveness of a provider-based intervention to improve medication intensification among patients with diabetes.Effectiveness cluster-randomised trial. Baseline and follow-up cross-sections of diabetes physicians' patients.Eleven U.S. Southeastern states, 2006-2008.205 Rural primary care physicians, 95 completed the study.Multicomponent interactive intervention including web-based continuing medical education (CME), performance feedback and quality improvement tools.Medication intensification, a dose increase of an existing medication or the addition of a new class of medication for glucose, blood pressure and lipids control on any of the three most recent office visits.Of 364 physicians attempting to register, 102 were randomised to the intervention and 103 to the control arms; 95 physicians (intervention, n=48; control, n=47) provided data on their 1182 of their patients at baseline (intervention, n=715; control, n=467) and 945 patients at follow-up (intervention, n=479; control, n=466). For A1c control, medication intensification increased in both groups (intervention, pre 26.4% vs post 32.6%, p=0.022; control, pre 24.8% vs post 31.1%, p=0.033) (intervention, adjusted OR (AOR) 1.37; 95% CI 1.06 to 1.76; control, AOR 1.41 (95% CI 1.06 to 1.89)); however, we observed no incremental benefit solely due to the intervention (group-by-time interaction, p=0.948). Among patients with the worst glucose control (A1c >9%), intensification increased in both groups (intervention, pre 34.8% vs post 62.5%, p=0.002; control, pre 35.7% vs post 61.4%, p=0.008).A wide-reach, low-intensity, web-based interactive multicomponent intervention had no significant incremental effect on medication intensification for control of glucose, blood pressure or lipids for patients with diabetes of physicians practising in the rural Southeastern USA.NCT00403091.
Project description:BACKGROUND:Self-monitoring and self-management, crucial for optimal glucose control in type 1 diabetes, requires many disease-related decisions per day and imposes a substantial disease burden on people with diabetes. Innovative technologies that integrate relevant measurements may offer solutions that support self-management, decrease disease burden, and benefit diabetes control. OBJECTIVE:The objective of our study was to evaluate a prototype integrated mobile phone diabetes app in people with type 1 diabetes. METHODS:In this exploratory study, we developed an app that contained cloud-stored log functions for glucose, carbohydrates (including a library), insulin, planned exercise, and mood, combined with a bolus calculator and communication functions. Adults with diabetes tested the app for 6 weeks. We assessed the feasibility of app use, user experiences, perceived disease burden (through questionnaires), insulin dose and basal to bolus ratio, mean glucose level, hemoglobin A1c, and number of hypoglycemic events. RESULTS:A total of 19 participants completed the study, resulting in 5782 data entries. The most frequently used feature was logging blood glucose, insulin, and carbohydrates. Mean diabetes-related emotional problems (measured with the Problem Areas in Diabetes scale) scores decreased from 14.4 (SD 10.0) to 12.2 (SD 10.3; P=.04), and glucose control improved, with hemoglobin A1c decreasing from 7.9% (mean 62.3, SD 8 mmol/mol) to 7.6% (mean 59.8, SD 7 mmol/mol; P=.047). The incidence of hypoglycemic events did not change. Participants were generally positive about the app, rating it as "refreshing," and as providing structure by reinforcing insulin-dosing principles. The app revealed substantial knowledge gaps. Logged data enabled additional detailed analyses. CONCLUSIONS:An integrated mobile diabetes app has the potential to improve diabetes self-management and provide tailored educational support, which may decrease disease burden and benefit diabetes control.
Project description:Importance:Elevated blood glucose levels are common in hospitalized older adults and may lead clinicians to intensify outpatient diabetes medications at discharge, risking potential overtreatment when patients return home. Objective:To assess how often hospitalized older adults are discharged with intensified diabetes medications and the likelihood of benefit associated with these intensifications. Design, Setting, and Participants:This retrospective cohort study examined patients aged 65 years and older with diabetes not previously requiring insulin. The study included patients who were hospitalized in a Veterans Health Administration hospital for common medical conditions between 2012 and 2013. Main Outcomes and Measures:Intensification of outpatient diabetes medications, defined as receiving a new or higher-dose medication at discharge than was being taken prior to hospitalization. Mixed-effect logistic regression models were used to control for patient and hospitalization characteristics. Results:Of 16?178 patients (mean [SD] age, 73  years; 15?895 [98%] men), 8535 (53%) had a preadmission hemoglobin A1c (HbA1c) level less than 7.0%, and 1044 (6%) had an HbA1c level greater than 9.0%. Overall, 1626 patients (10%) were discharged with intensified diabetes medications including 781 (5%) with new insulins and 557 (3%) with intensified sulfonylureas. Nearly half of patients receiving intensifications (49% [791 of 1626]) were classified as being unlikely to benefit owing to limited life expectancy or already being at goal HbA1c, while 20% (329 of 1626) were classified as having potential to benefit. Both preadmission HbA1c level and inpatient blood glucose recordings were associated with discharge with intensified diabetes medications. Among patients with a preadmission HbA1c level less than 7.0%, the predicted probability of receiving an intensification was 4% (95% CI, 3%-4%) for patients without elevated inpatient blood glucose levels and 21% (95% CI, 15%-26%) for patients with severely elevated inpatient blood glucose levels. Conclusions and Relevance:In this study, 1 in 10 older adults with diabetes hospitalized for common medical conditions was discharged with intensified diabetes medications. Nearly half of these individuals were unlikely to benefit owing to limited life expectancy or already being at their HbA1c goal.
Project description:<h4>Background</h4>Management of diabetes in pregnancy is burdensome due to self-glucose monitoring, recording, and reporting demands. Cellular-enabled glucometers provide real-time transmission of glucose values independent of internet access and cell phone data plans. We describe a quality improvement (QI) intervention that introduced cellular-enabled glucometers for use during pregnancies complicated by diabetes.<h4>Methods</h4>Our aim was to improve maternal glucose control in a cohort of insulin-requiring pregnant women enrolled in a telemedicine diabetes program. During initial establishment of a QI program, women were offered cellular-enabled glucometers but could elect to keep their standard meter. The primary outcome evaluated was glycosylated hemoglobin A1c (HbA1c) at delivery.<h4>Results</h4>Baseline characteristics including initial HbA1c were similar between women using a standard glucometer (n = 45) and those using a cellular-enabled glucometer (n = 72). Women who used a cellular-enabled glucometer had a lower HbA1c at delivery compared to those using a standard glucometer (5.8% vs 6.3%, <i>P</i> = .03). This improvement was particularly notable for women with poor glucose control (defined as HbA1c >6.5%) at initial obstetric visit. Women with poor glucose control who used a cellular-enabled glucose monitor had significantly lower HbA1c at delivery (6.0% vs 6.8%, <i>P</i> = .03) and greater change from initial visit compared to those using a standard glucometer (-2.6% vs -1.4%, <i>P</i> = .02). No statistically significant differences were detected in tracked neonatal outcomes.<h4>Conclusion</h4>For pregnancies complicated by insulin-requiring diabetes, use of cellular-enabled glucometers as part of a perinatal diabetes program improves glucose control at delivery with timely transmission of accurate values throughout gestation.
Project description:In diabetic adults, tight control of risk factors reduces complications.To determine whether failure to make visits, monitor risk factors, or intensify therapy affects control of blood pressure, glucose, and lipids.A non-concurrent, prospective study of data from electronic files and standardized abstraction of hard-copy medical records for the period 1/1/1999-12/31/2001.Three hundred eighty-three adults with diabetes managed in an academically affiliated managed care program.Main exposure variable: Intensification of therapy or failure to intensify, reckoned on a quarterly basis.Hemoglobin A1c (A1c), systolic blood pressure (SBP), and LDL-cholesterol at the end of the interval.In this visit-adherent cohort, control of glycemia and lipids showed improvement over 24 months, but many patients did not achieve targets. Only those with the worst blood pressure control (SBP >or=160 mmHg) showed any improvement over 2 years. Failure to intensify treatment in patients who kept visits was the single strongest predictor of sub-optimal control. Compared to their counterparts with no failures of intensification, patients with failures in >or=3 quarters showed markedly worse control of blood glucose (A1c 1.4% higher: 95% CI: 0.7, 2.1); hypertension (SBP 22.2 mmHg higher: 95% CI: 16.6, 27.9) and LDL cholesterol (LDL 43.7 mg/dl higher: 95% CI: 24.1, 63.3). These relationships were strong, graded, and independent of socio-demographic factors, baseline risk factor values, and co-morbidities.Failure to intensify therapy leads to suboptimal control, even with adequate visits and monitoring. Interventions designed to promote appropriate intensification should enhance diabetes care in primary practice.
Project description:BACKGROUND:Diabetes is a global epidemic affecting approximately 30 million people in the United States. The World Health Organization recommends using technology and telecommunications to improve health care delivery and disease management. The Livongo for Diabetes Program offers a remote monitoring technology with Certified Diabetes Educator outreach. OBJECTIVE:The purpose of this study was to examine health outcomes measured by changes in HbA1c, in time in target blood glucose range, and in depression symptoms for patients enrolled in a remote digital diabetes management program in a Diabetes Center of Excellence setting. METHODS:The impact of the Livongo for Diabetes program on hemoglobin A1c (HbA1c), blood glucose ranges, and depression screening survey results (Patient Health Questionnaire-2 [PHQ-2]) were assessed over 12 months in a prospective cohort recruited from the University of South Florida Health Diabetes Home for Healthy Living. Any patient ?18 years old with a diagnosis of diabetes was approached for voluntary inclusion into the program. The analysis was a pre-post design for those members enrolled in the study. Data was collected at outpatient clinic visits and remotely through the Livongo glucose meter. RESULTS:A total of 86 adults were enrolled into the Livongo for Diabetes program, with 49% (42/86) female, an average age of 50 (SD 15) years, 56% (48/86) with type 2 diabetes mellitus, and 69% (59/86) with insulin use. The mean HbA1c drop amongst the group was 0.66% (P=.17), with all participants showing a decline in HbA1c at 12 months. A 17% decrease of blood glucose checks <70 mg/dL occurred concurrently. Participants with type 2 diabetes not using insulin had blood glucose values within target range (70-180 mg/dL) 89% of the time. Participants with type 2 diabetes using insulin were in target range 68% of the time, and type 1 diabetes 58% of the time. Average PHQ-2 scores decreased by 0.56 points during the study period. CONCLUSIONS:Participants provided with a cellular-enabled blood glucose meter with real-time feedback and access to coaching from a certified diabetes educator in an outpatient clinical setting experienced improved mean glucose values and fewer episodes of hypoglycemia relative to the start of the program.
Project description:ASPIRE In-Home randomized 247 subjects with type 1 diabetes to sensor-augmented pump therapy with or without the Threshold Suspend (TS) feature, which interrupts insulin delivery at a preset sensor glucose value. We studied the effects of TS on nocturnal hypoglycemia (NH) in relation to baseline hemoglobin A1c (A1C) and change in A1C during the study.NH event rates and mean area under curve (AUC) of NH events were evaluated at different levels of baseline A1C (<7%, 7-8%, and >8%) and at different levels of changes in A1C (less than -0.3% [decreased], -0.3% to 0.3% [stable], and >0.3% [increased]), in the TS Group compared with the Control Group (sensor-augmented pump only).In the TS Group, 27.9% of the NH events were accompanied by a confirmatory blood glucose value, compared with 39.3% in the Control Group. Among subjects with baseline A1C levels of <7% or 7-8%, those in the TS Group had significantly lower NH event rates than those in the Control Group (P=0.001 and P=0.004, respectively). Among subjects with decreased or stable A1C levels, those in the TS Group had significantly lower NH event rates, and the events had lower AUCs (P?0.001 for each). Among subjects with increased A1C levels, those in the TS Group had NH events with significantly lower AUCs (P<0.001).Use of the TS feature was associated with decreases in the rate and severity (as measured by AUC) of NH events in many subjects, including those with low baseline A1C levels and those whose A1C values decreased during the study period. Use of the TS feature can help protect against hypoglycemia in those wishing to intensify diabetes management to achieve target glucose levels.