Showing papers in "Diabetes Technology & Therapeutics in 2015"

The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System.

Abstract: Introduction: The purpose of the study was to evaluate the performance and usability of the FreeStyle® Libre™ Flash glucose monitoring system (Abbott Diabetes Care, Alameda, CA) for interstitial glucose results compared with capillary blood glucose results. Materials and Methods: Seventy-two study participants with type 1 or type 2 diabetes were enrolled by four U.S. clinical sites. A sensor was inserted on the back of each upper arm for up to 14 days. Three factory-only calibrated sensor lots were used in the study. Sensor glucose measurements were compared with capillary blood glucose (BG) results (approximately eight per day) obtained using the BG meter built into the reader (BG reference) and with the YSI analyzer (Yellow Springs Instrument, Yellow Springs, OH) reference tests at three clinic visits (32 samples per visit). Sensor readings were masked to the participants. Results: The accuracy of the results was demonstrated against capillary BG reference values, with 86.7% of sensor results w...

Computer-based interventions to improve self-management in adults with type 2 diabetes: A systematic review and meta-analysis

Abstract: OBJECTIVE Structured patient education programs can reduce the risk of diabetes-related complications. However, people appear to have difficulties attending face-to-face education and alternatives are needed. This review looked at the impact of computer-based diabetes self-management interventions on health status, cardiovascular risk factors, and quality of life of adults with type 2 diabetes. RESEARCH DESIGN AND METHODS We searched The Cochrane Library, Medline, Embase, PsycINFO, Web of Science, and CINAHL for relevant trials from inception to November 2011. Reference lists from relevant published studies were screened and authors contacted for further information when required. Two authors independently extracted relevant data using standard data extraction templates. RESULTS Sixteen randomized controlled trials with 3,578 participants met the inclusion criteria. Interventions were delivered via clinics, the Internet, and mobile phones. Computer-based diabetes self-management interventions appear to have small benefits on glycemic control: the pooled effect on HbA 1c was −0.2% (−2.3 mmol/mol [95% CI −0.4 to −0.1%]). A subgroup analysis on mobile phone–based interventions showed a larger effect: the pooled effect on HbA 1c from three studies was −0.50% (−5.46 mmol/mol [95% CI −0.7 to −0.3%]). There was no evidence of improvement in depression, quality of life, blood pressure, serum lipids, or weight. There was no evidence of significant adverse effects. CONCLUSIONS Computer-based diabetes self-management interventions to manage type 2 diabetes appear to have a small beneficial effect on blood glucose control, and this effect was larger in the mobile phone subgroup. There was no evidence of benefit for other biological, cognitive, behavioral, or emotional outcomes.

Assessing sensor accuracy for non-adjunct use of continuous glucose monitoring.

Abstract: Background: The level of continuous glucose monitoring (CGM) accuracy needed for insulin dosing using sensor values (i.e., the level of accuracy permitting non-adjunct CGM use) is a topic of ongoing debate. Assessment of this level in clinical experiments is virtually impossible because the magnitude of CGM errors cannot be manipulated and related prospectively to clinical outcomes. Materials and Methods: A combination of archival data (parallel CGM, insulin pump, self-monitoring of blood glucose [SMBG] records, and meals for 56 pump users with type 1 diabetes) and in silico experiments was used to “replay” real-life treatment scenarios and relate sensor error to glycemic outcomes. Nominal blood glucose (BG) traces were extracted using a mathematical model, yielding 2,082 BG segments each initiated by insulin bolus and confirmed by SMBG. These segments were replayed at seven sensor accuracy levels (mean absolute relative differences [MARDs] of 3–22%) testing six scenarios: insulin dosing using se...

Ethnic-Specific Criteria for Classification of Body Mass Index: A Perspective for Asian Indians and American Diabetes Association Position Statement.

Abstract: Definitions for overweight and obesity are universally applied using body mass index (BMI), based on morbidity and mortality data derived from white populations. However, several studies have shown higher body fat, excess metabolic perturbations, and cardiovascular risk factors at lower value of BMI in Asian versus white populations. Definitive guidelines have been published to classify a BMI of ≥23 kg/m2 and ≥25 kg/m2 as overweight and obese, respectively, by the Indian Consensus Group (for Asian Indians residing in India) and a BMI of ≥23 kg/m2 for screening for diabetes by the National Institute of Health and Care Excellence of the United Kingdom (for migrant south Asians) and, in an encouraging initiative recently (2015), by the American Diabetes Association (for all Asian ethnic groups in the United States). Overall, multiple studies, and now several guidelines, emphasize early intervention with diet and physical activity in Asian ethnic groups for prevention and management of obesity-relate...

Telemedicine application in the care of diabetes patients: Systematic review and meta-analysis

Abstract: Background: The impact of telemedicine application on the management of diabetes patients is unclear, as the results are not consistent among different studies. The objective of this study is to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) assessing the impact of telemedicine interventions on change in hemoglobin A1c (HbA1c), blood pressure, LDL cholesterol (LDL-c) and body mass index (BMI) in diabetes patients. Methods: Electronic databases MEDLINE, Cochrane Central Register of Controlled Trials and LILACS were searched to identify relevant studies published until April 2012, supplemented by references from the selected articles. Study search and selection were performed by independent reviewers. Of the 6.258 articles retrieved, 13 RCTs (4207 patients) were included. Random effects model was applied to estimate the pooled results. Results: Telemedicine was associated with a statistically significant and clinically relevant absolute decline in HbA1c level compared to control (mean difference -0.44% [-4.8 mmol/mol] and 95% confidence interval [CI] -0.61 to -0.26% [-6.7 to -2.8 mmol/mol]; p<0.001). LDL-c was reduced in 6.6 mg/dL (95% CI -8.3 to -4.9; p<0.001), but the clinical relevance of this effect can be questioned. No effects of telemedicine strategies were seen on systolic (-1.6 mmHg and 95% CI -7.2 to 4.1) and diastolic blood pressure (-1.1 mmHg and 95% CI -3.0 to 0.8). The 2 studies that assessed the effect on BMI demonstrated a tendency of BMI reduction in favor of telemedicine. Conclusions: Telemedicine strategies combined to the usual care were associated with improved glycemic control in diabetic patients. No clinical relevant impact was observed on LDL-c and blood pressure, and there was a tendency of BMI reduction in diabetes patients who used telemedicine, but these outcomes should be further explored in future trials.

Internet delivered diabetes self-management education: a review.

Abstract: Background: Diabetes self-management education is a cornerstone of successful diabetes management. Various methods have been used to reach the increasing numbers of patients with diabetes, including Internet-based education. The purpose of this article is to review various delivery methods of Internet diabetes education that have been evaluated, as well as their effectiveness in improving diabetes-related outcomes. Materials and Methods: Literature was identified in the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PubMed, Medline, EBSCO, the Cochrane Library, and the Web of Science databases through searches using the following terms: “type 2 diabetes AND internet/web based AND education” and “type 2 diabetes AND diabetes self-management education (DSME) AND web-based/internet OR technology assisted education.” The search was limited to English language articles published in the last 10 years. The search yielded 111 articles; of these, 14 met criteria for inclusion in this r...

EHealth interventions for the prevention and treatment of overweight and obesity in adults: A systematic review with meta-analysis

Abstract: Summary A systematic review of randomized controlled trials was conducted to evaluate the effectiveness of eHealth interventions for the prevention and treatment of overweight and obesity in adults. Eight databases were searched for studies published in English from 1995 to 17 September 2014. Eighty-four studies were included, with 183 intervention arms, of which 76% (n = 139) included an eHealth component. Sixty-one studies had the primary aim of weight loss, 10 weight loss maintenance, eight weight gain prevention, and five weight loss and maintenance. eHealth interventions were predominantly delivered using the Internet, but also email, text messages, monitoring devices, mobile applications, computer programs, podcasts and personal digital assistants. Forty percent (n = 55) of interventions used more than one type of technology, and 43.2% (n = 60) were delivered solely using eHealth technologies. Meta-analyses demonstrated significantly greater weight loss (kg) in eHealth weight loss interventions compared with control (MD −2.70 [−3.33,−2.08], P < 0.001) or minimal interventions (MD −1.40 [−1.98,−0.82], P < 0.001), and in eHealth weight loss interventions with extra components or technologies (MD 1.46 [0.80, 2.13], P < 0.001) compared with standard eHealth programmes. The findings support the use of eHealth interventions as a treatment option for obesity, but there is insufficient evidence for the effectiveness of eHealth interventions for weight loss maintenance or weight gain prevention.

Circadian variability of insulin sensitivity: physiological input for in silico artificial pancreas.

Abstract: Background: Closed-loop control clinical research trials have been considerably accelerated by in silico trials using the Food and Drug Administration–accepted type 1 diabetes mellitus (T1DM) simulator. We have recently demonstrated that postprandial insulin sensitivity (SI) in T1DM subjects was lower at breakfast (B) than lunch (L) and dinner (D), but not significantly, because of the small population size. The goal of this study was therefore to incorporate this novel information into the University of Virginia/Padova T1DM simulator and to reproduce in silico the observed circadian variability. Subjects and Methods: Twenty T1DM subjects received an identical mixed meal at B, L, and D. SI was calculated for each meal using the oral glucose minimal model. Seven SI daily patterns were identified, and their probabilities were estimated. Each in silico subject was linked to a time-varying SI profile, while random deviations of up to 40% were allowed. Results: Simulations were compared with experimen...

Exercise prevents fructose-induced hypertriglyceridemia in healthy young subjects

Abstract: Excess fructose intake causes hypertriglyceridemia and hepatic insulin resistance in sedentary humans. Since exercise improves insulin sensitivity in insulin-resistant patients, we hypothesized that it would also prevent fructose-induced hypertriglyceridemia. This study was therefore designed to evaluate the effects of exercise on circulating lipids in healthy subjects fed a weight-maintenance, high-fructose diet. Eight healthy males were studied on three occasions after 4 days of 1) a diet low in fructose and no exercise (C), 2) a diet with 30% fructose and no exercise (HFr), or 3) a diet with 30% fructose and moderate aerobic exercise (HFrEx). On all three occasions, a 9-h oral [(13)C]-labeled fructose loading test was performed on the fifth day to measure [(13)C]palmitate in triglyceride-rich lipoprotein (TRL)-triglycerides (TG). Compared with C, HFr significantly increased fasting glucose, total TG, TRL-TG concentrations, and apolipoprotein (apo)B48 concentrations as well as postfructose glucose, total TG, TRL-TG, and [(13)C]palmitate in TRL-TG. HFrEx completely normalized fasting and postfructose TG, TRL-TG, and [(13)C]palmitate concentration in TRL-TG and apoB48 concentrations. In addition, it increased lipid oxidation and plasma nonesterified fatty acid concentrations compared with HFr. These data indicate that exercise prevents the dyslipidemia induced by high fructose intake independently of energy balance.

Gastrointestinal Adverse Events of Glucagon-Like Peptide-1 Receptor Agonists in Patients with Type 2 Diabetes: A Systematic Review and Network Meta-Analysis

Abstract: Introduction: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are a new class of drugs used in the treatment of type 2 diabetes mellitus (T2DM). Gastrointestinal (GI) adverse events (AEs) are the most frequently reported treatment-related AEs for GLP-1 RAs. We aim to evaluate the effect of GLP-1 RAs on the incidence of GI AEs of T2DM. Materials and Methods: The overview of the GI events of GLP-1 RAs has been performed on relevant publications through the literature search, such as MEDLINE, EMBASE, Cochrane Library, and ClinicalTrials.gov The manufacturer was contacted regarding unpublished data. We analyzed direct and indirect comparisons of different treatments using Bayesian network meta-analysis. Results: Taspoglutide 30 mg once weekly (TAS30QW) and lixisenatide 30 μg twice daily (LIX30BID) were ranked the top two drugs in terms of GI AEs versus placebo. The odds ratios of nausea and vomiting for TAS30QW were 11.8 (95% confidence interval [CI], 2.89, 46.9) and 51.7 (95% CI, 7.07, 415), r...

Patient satisfaction with video teleconsultation in a virtual diabetes outreach clinic.

Abstract: Objective: This study assessed the level of patient satisfaction with diabetes remote consultations via videoconferencing in a virtual outreach clinic. Materials and Methods: A cross-sectional observational survey was conducted of people with diabetes who were living in regional cities of Queensland, Australia, and remotely consulted by endocrinologists at the Princess Alexandra Hospital tele-endocrinology clinic in Brisbane during autumn 2013. A questionnaire with 15 multiple-choice questions and one open-ended question was developed for assessing patient satisfaction with videoconferencing for specialty consultation. The questionnaire items showed strong internal consistency (Cronbach's α=0.90). Patient satisfaction was assessed by this 16-item questionnaire exploring four dimensions: equipment/technical issues; communication and rapport; clinical assessment; and program evaluation. Results: In total, 62 questionnaires were mailed to the patients, with 24 (39%) surveys completed and returned. T...

Efficacy and safety of metformin for patients with type 1 diabetes mellitus: a meta-analysis.

Abstract: Background: Insulin is an essential therapy for patients with type 1 diabetes mellitus (T1DM). With the progression of the disease, many patients with T1DM may have an increased prevalence of insulin resistance; thus the common standard insulin therapy requires a high insulin dosage (>1 unit/kg/day) and is usually associated with many side effects. Studies have shown that metformin may benefit those insulin-resistant individuals with T1DM. This meta-analysis was performed to provide the evidence of clinical efficacy and safety of metformin in T1DM. Materials and Methods: We conducted a search on Medline, EMBASE, and the Cochrane Library for relevant studies published before May 2014 based on “metformin” and “diabetes mellitus, type 1.” The following outcomes were evaluated: hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), lipid metabolism, weight, insulin dosage, hypoglycemia, diabetic ketoacidosis, or gastrointestinal adverse events (AEs). The meta-analysis was performed using Review Manage...

Multinight "bedside" closed-loop control for patients with type 1 diabetes.

Abstract: Background: Studies of closed-loop control (CLC) systems have improved glucose levels in patients with type 1 diabetes. In this study we test a new CLC concept aiming to “reset” the patient overnight to near-normoglycemia each morning, for several consecutive nights. Subjects and Methods: Ten insulin pump users with type 1 diabetes (mean age, 46.4±8.5 years) were enrolled in a two-center (in the United States and Italy) randomized crossover trial comparing 5 consecutive nights of CLC (23:00–07:00 h) in an outpatient setting versus sensor-augmented insulin pump therapy of the same duration at home. Primary end points included time spent in 80–140 mg/dL as measured by continuous glucose monitoring overnight and fasting blood glucose distribution at 7:00 h. Results: Compared with sensor-augmented pump therapy, CLC improved significantly time spent between 80 and 140 mg/dL (54.5% vs. 32.2%; P<0.001) and between 70 and 180 mg/dL (85.4% vs. 59.1%; P<0.001); CLC reduced the mean glucose level at 07:00 h...

Electrochemiluminescence assays for insulin and glutamic acid decarboxylase autoantibodies improve prediction of type 1 diabetes risk.

Abstract: We recently developed new electrochemiluminescence (ECL) insulin autoantibody (IAA) and glutamic acid decarboxylase 65 autoantibody (GADA) assays that discriminate high-affinity, high-risk diabetes-specific autoantibodies from low-affinity, low-risk islet autoantibodies (iAbs) detected by radioassay (RAD) Here, we report a further validation of the ECL-IAA and -GADA assays in 3,484 TrialNet study participants The ECL assay and RAD were congruent in those with prediabetes and in subjects with multiple autoantibodies, but only 24% (P<00001) of single RAD-IAA-positive and 46% (P<00001) of single RAD-GADA-positive were confirmed by the ECL-IAA and -GADA assays, respectively During a follow-up (mean, 24 years), 51% of RAD-IAA-positive and 63% of RAD-GADA-positive subjects not confirmed by ECL became iAb negative, compared with only 17% of RAD-IAA-positive (P<00001) and 15% of RAD-GADA-positive (P<00001) subjects confirmed by ECL assays Among subjects with multiple iAbs, diabetes-free survival

A Minority of Patients with Type 1 Diabetes Routinely Downloads and Retrospectively Reviews Device Data

Abstract: Background: In type 1 diabetes (T1D), periodic review of blood glucose and insulin dosing should be performed, but it is not known how often patients review these data on their own. We describe the proportion of patients with T1D who routinely downloaded and reviewed their data at home. Materials and Methods: A cross-sectional survey of 155 adults and 185 caregivers of children with T1D at a single academic institution was performed. “Routine Downloaders” (downloaded four or more times in the past year) were also considered “Routine Reviewers” if they reviewed their data most of the time they downloaded from devices. Logistic regression was used to identify factors associated with being a Routine Reviewer. Results: Only 31% of adults and 56% of caregivers reported ever downloading data from one or more devices, whereas 20% and 40%, respectively, were considered Routine Downloaders. Only 12% of adults and 27% of caregivers were Routine Reviewers. Mean hemoglobin A1c was lower in Routine Reviewers ...

Quantifying direct effects of social determinants of health on glycemic control in adults with type 2 diabetes.

Abstract: Background: The aim of this study was to investigate if self-care is the pathway through which social determinants of health impact diabetes outcomes by analyzing the direct and indirect effects of socioeconomic and psychosocial factors on self-care and glycemic control. Subjects and Methods: Six hundred fifteen adults were recruited from two primary care clinics in the southeastern United States. A series of confirmatory factor analyses identified the latent factors underlying social status, psychosocial determinants (psychological distress, self-efficacy, and social support), and self-care (diet, exercise, foot care, glucose testing, and medication adherence). Structured equation modeling investigated the relationship among social determinants, self-care and glycemic control. Results: Latent variables were created for diabetes self-care, psychological distress, self-efficacy, social support, and social status. The final model [χ2(275)=450.07, P<0.001, R2=99, root mean square error of approximat...

Hypoglycemia Reduction and Changes in Hemoglobin A1c in the ASPIRE In-Home Study.

Abstract: Background: 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. Materials and Methods: NH event rates and mean area under curve (AUC) of NH events were evaluated at different levels of baseline A1C ( 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). Results: 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). Conclusions: 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.

Development of a New Measure for Assessing Glucose Monitoring Device-Related Treatment Satisfaction and Quality of Life

Abstract: Background: Many different devices are available to patients to measure glucose levels, but there is no validated method to assess treatment satisfaction with glucose monitoring devices and its impact on quality of life and other patient-reported outcomes. To address this problem, we developed the Glucose Monitoring System Satisfaction Survey (GMSS). We describe the construction and validation of the GMSS and examine how key patient factors are associated with glucose device satisfaction. Materials and Methods: Items were developed from interviews with 15 adults with either type 1 diabetes (T1D) or type 2 diabetes (T2D) and 10 diabetes healthcare professionals, resulting in an initial pool of 42 items. Separate exploratory factor analyses (EFAs) were conducted with adults with T1D (n=254) and with insulin-using T2D (n=206). Construct validity was established with overall well-being (World Health Organization-5), diabetes distress (Diabetes Distress Scale), attitudes toward glucose monitoring (Sel...

Accuracy evaluation of contour next compared with five blood glucose monitoring systems across a wide range of blood glucose concentrations occurring in a clinical research setting.

Abstract: Background: This study evaluated the accuracy of Contour® Next (CN; Bayer HealthCare LLC, Diabetes Care, Whippany, NJ) compared with five blood glucose monitoring systems (BGMSs) across a wide range of clinically occurring blood glucose levels Subjects and Methods: Subjects (n=146) were ≥18 years and had type 1 or type 2 diabetes Subjects' glucose levels were safely lowered or raised to provide a wide range of glucose values Capillary blood samples were tested on six BGMSs and a YSI glucose analyzer (YSI Life Sciences, Inc, Yellow Springs, OH) as the reference Extreme glucose values were achieved by glucose modification of the blood sample System accuracy was assessed by mean absolute difference (MAD) and mean absolute relative difference (MARD) across several glucose ranges, with <70 mg/dL evaluated by MAD as the primary end point Results: In the low glucose range (<70 mg/dL), MAD values were as follows: Accu-Chek® Aviva Nano (Roche Diagnostics, Indianapolis, IN), 334 mg/dL; CN, 203 mg/

Future artificial pancreas technology for type 1 diabetes: what do users want?

Abstract: Background: The primary focus of artificial pancreas (AP) research has been on technical achievements, such as time in range for glucose levels or prevention of hypoglycemia. Few studies have attempted to ascertain the expectations of users of AP technology. Subjects and Methods: Persons with type 1 diabetes and parents of children with type 1 diabetes were invited to take part in an online survey concerning future use and expectations of AP technology. The survey was advertised via Twitter, Facebook, and DiabetesMine, plus advocacy groups and charities including INPUT, Diabetes UK, and the Diabetes Research and Wellness Foundation. Quantitative responses were categorized on a 5-point Likert scale. Free text responses were analyzed using content analysis. Results: Two hundred sixty-six surveys were completed over a 1-month period. Two hundred forty participants indicated they were highly likely to use a fully automated 24-h AP. Approximately half of the respondents indicated they would be likely ...

A Randomized Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Patients with Type 2 Diabetes

Abstract: Background: This study evaluated whether a home telehealth (HT) system enabling the patient to monitor body weight, blood glucose values, and blood pressure values, associated with remote educational support and feedback to the general practitioner, can improve metabolic control and overall cardiovascular risk in individuals with type 2 diabetes mellitus, compared with usual practice. Materials and Methods: This was a randomized, parallel-group (1:1), open-label, multicenter study conducted in general practice. Follow-up was for 12 months. Results: Overall, 29 general practitioners enrolled 302 patients (153 assigned to the HT group and 149 to the control group). Use of the HT system was associated with a statistically significant reduction in glycated hemoglobin (HbA1c) levels compared with the control group (estimated mean difference, 0.33±0.1; P=0.001). No difference emerged as for body weight, blood pressure, and lipid profile. The proportion of patients reaching the target of HbA1c <7.0% was...

Tele-Mum: A Feasibility Study for a Randomized Controlled Trial Exploring the Potential for Telemedicine in the Diabetes Care of Those with Gestational Diabetes

Abstract: Background: The incidence of gestational diabetes mellitus (GDM)—hyperglycemia with onset or first recognition during pregnancy—is increasing and will have a significant impact on diabetes services. This study aimed to determine the feasibility and acceptability of using telemedicine in the diabetes care of women with GDM and the possibility of replacing alternate (one in every two) diabetes review appointments with telemedicine. Subjects and Methods: A feasibility study for a randomized controlled trial was conducted across two sites. Fifty women with GDM were randomized to usual care (n = 26) or usual care plus telemedicine (n = 24). Telemedicine entailed weekly blood pressure and weight measurements and transmission of these data, along with blood glucose readings, for review by the healthcare team. Patients were contacted about these results as necessary. Patients completed questionnaires to measure their satisfaction with telemedicine or blood glucose monitoring. The intervention group and h...

Older Adult Self-Efficacy Study of Mobile Phone Diabetes Management

Abstract: The purpose of this study was to evaluate participant self-efficacy and use of a mobile phone diabetes health intervention for older adults during a 4-week period. Participants included seven adults (mean age, 70.3 years) with type 2 diabetes cared for by community-based primary care physicians. Participants entered blood glucose data into a mobile phone and personalized patient Internet Web portal. Based on blood glucose values, participants received automatic messages and educational information to self-manage their diabetes. Study measures included prior mobile phone/Internet use, the Stanford Self-Efficacy for Diabetes Scale, the Stanford Energy/Fatigue Scale, the Short Form-36, the Patient Health Questionnaire-9 (depression), the Patient Reported Diabetes Symptom Scale, the Diabetes Stages of Change measure, and a summary of mobile system use. Participants had high self-efficacy and high readiness and confidence in their ability to monitor changes to control their diabetes. Participants demo...

Web-based telemedicine system is useful for monitoring glucose control in pregnant women with diabetes.

Abstract: Objective: The aim of this study was to examine the impact of a Web-based telemedicine system for monitoring glucose control in pregnant women with diabetes on healthcare visits, metabolic control, and pregnancy outcomes. Subjects and Methods: A prospective, single-center, interventional study with two parallel groups was performed in Puerto Real University Hospital (Cadiz, Spain). Women were assigned to two different glucose monitoring groups: the control group (CG), which was managed only by follow-ups with the Gestational Diabetes Unit (GDU), and the telemedicine group (TMG), which was monitored by both more spaced GDU visits and a Web-based telemedicine system. The number of healthcare visits, degree of metabolic control, and maternal and neonatal outcomes were evaluated. Results: One hundred four pregnant women with diabetes (77 with gestational diabetes, 16 with type 1 diabetes, and 11 with type 2 diabetes) were included in the TMG (n=40) or in the CG (n=64). There were no significant diffe...

Data-Driven Personalized Feedback to Patients with Type 1 Diabetes: A Randomized Trial

Abstract: Background: A mobile phone-based application can be useful for patients with type 1 diabetes in managing their disease. This results in large datasets accumulated on the patient's devices, which can be used for individualized feedback. The effect of such feedback is investigated in this article. Materials and Methods: We developed an application that included a data-driven feedback module known as Diastat for patients on self-measured blood glucose regimens. Using a stepped-wedge design, both groups initially received an application without Diastat. Group 1 activated Diastat after 4 weeks, whereas Group 2 activated Diastat 12 weeks after startup (T1). End points were glycated hemoglobin (HbA1c) level and number of out-of-range (OOR) measurements (i.e., outside the range 72–270 mg/dL). Results: Thirty patients were recruited to the study, and 15 were assigned to each group after the initial meeting. There were no significant differences between groups at T1 in HbA1c or OOR events. Overall, all pat...

Standardized Glycemic Management with a Computerized Workflow and Decision Support System for Hospitalized Patients with Type 2 Diabetes on Different Wards.

Abstract: Background: This study investigated the efficacy, safety, and usability of standardized glycemic management by a computerized decision support system for non-critically ill hospitalized patients with type 2 diabetes on four different wards. Materials and Methods: In this open, noncontrolled intervention study, glycemic management of 99 patients with type 2 diabetes (62% acute admissions; 41 females; age, 67±11 years; hemoglobin A1c, 65±21 mmol/mol; body mass index, 30.4±6.5 kg/m2) on clinical wards (Cardiology, Endocrinology, Nephrology, Plastic Surgery) of a tertiary-care hospital was guided by GlucoTab® (Joanneum Research GmbH [Graz, Austria] and Medical University of Graz [Graz, Austria]), a mobile decision support system providing automated workflow support and suggestions for insulin dosing to nurses and physicians. Results: Adherence to insulin dosing suggestions was high (96.5% bolus, 96.7% basal). The primary outcome measure, percentage of blood glucose (BG) measurements in the range of 7...

Psychosocial Assessment of Artificial Pancreas (AP): Commentary and Review of Existing Measures and Their Applicability in AP Research

Abstract: Aim: This study aimed to systematically review the evidence base for the use of existing psychological and psychosocial measures suitable for use in artificial pancreas (AP) research. Materials and Methods: This systematic review of published literature, gray literature, previous systematic reviews, and qualitative and economic studies was conducted using terms and abbreviations synonymous with diabetes, AP, and quality of life (QoL). Results: Two hundred ninety-two abstracts were identified that reported psychosocial assessment of diabetes-related technologies. Of these, nine met the inclusion criteria and were included. Only four of 103 ongoing trials evaluated psychosocial aspects as an outcome in the trial. Of these, treatment satisfaction, acceptance and use intention of AP, fear of hypoglycemia episodes, satisfaction with AP, and an unspecified QoL measure were used. Conclusions: A better understanding of the psychosocial side of AP systems and the extent to which human factors play a role ...