Usual Diabetes Care Research Articles

Effect of interdisciplinary obesity care on metabolic markers and body weight in people with type 2 diabetes in a rural setting: A randomised controlled trial

SummaryManagement of type 2 diabetes includes medications that can unintentionally increase obesity and insulin resistance. This unblinded, single‐centre, randomised controlled trial focused on rural Australian adults with type 2 diabetes (aged 18–75 and body mass index [BMI] >30 kg/m2), measuring the effectiveness of a tailored interdisciplinary obesity care approach compared with usual diabetes care. Led by a nurse practitioner with allied health support (dietitian ± psychologist and physiotherapist), the bariatric treatment involved reducing weight‐gaining medications, a 500‐calories/day deficit, an unsupervised exercise program emphasising movement/strength and psychotherapy, 3‐monthly to 24‐months with support phone calls at weeks 2, 4, 8 and 10. Outcomes from the 224 (113 intervention/111 control) participants were differences in biomedical and physical markers within‐ and between‐groups estimated using multivariate mixed‐effects linear regression between recruitment and 6‐monthly follow‐ups. Greater change occurred in intervention compared with control groups at 12 and 24 months in mean: body weight (−5.9 kg [95% confidence interval, CI: −8.53, −3.23] and −9.0 kg [95% CI: −13.2, −4.77]); BMI (−2.03 kg/m2 [95% CI: −2.92, −1.15] and −3.51 kg/m2 [95% CI: −4.93, −2.08]); and glycated haemoglobin (−0.26% [95% CI: −0.69%, 0.18%] and −0.63% [95% CI: −1.17%, 0.08%]). The control group showed a significant increase in mean leptin level, resulting in a between‐group difference (−27.1 [95% CI: −42.7, −11.5]). Lipids and blood pressure differences were inconclusive, while exploratory analysis showed greater decline in estimated glomerular filtration rate in the control group. The interdisciplinary obesity approach, compared with usual diabetes care, resulted in sustained weight loss and improved diabetes control over 2 years. Trial registration number: ACTRN12622000240741.

Automated Insulin Delivery for Young People with Type 1 Diabetes and Elevated A1c

BackgroundAutomated insulin delivery is the treatment of choice in adults with type 1 diabetes. Data are needed on the efficacy and safety of automated insulin delivery for children and youth with diabetes and elevated glycated hemoglobin levels.MethodsIn this multicenter, open-label randomized controlled trial, we assigned patients with type 1 diabetes in a 1:1 ratio either to use an automated insulin delivery system (MiniMed 780G) or to receive usual diabetes care of multiple daily injections or non-automated pump therapy (control). The patients were children and youth (defined as 7 to 25 years of age) with elevated glycemia (glycated hemoglobin ≥8.5% with no upper limit). The primary outcome was the baseline-adjusted between-group difference in glycated hemoglobin at 13 weeks.ResultsA total of 80 patients underwent randomization (37 to automated insulin delivery and 43 to control) and all patients completed the trial. At 13 weeks, the mean (±SD) glycated hemoglobin decreased from 10.5±1.9% to 8.1±1.8% in the automated insulin delivery group but remained relatively consistent in the control group, changing from 10.4±1.6% to 10.6±1.8% (baseline-adjusted between-group difference, −2.5 percentage points; 95% confidence interval [CI], −3.1 to −1.8; P<0.001). Patients in the automated insulin delivery group spent on average 8.4 hours more in the target glucose range of 70 to 180 mg/dl than those in the control group. One severe hypoglycemia event and two diabetic ketoacidosis events occurred in the control group, with no such events in the automated insulin delivery group.ConclusionsIn this trial of 80 children and youth with elevated glycated hemoglobin, automated insulin delivery significantly reduced glycated hemoglobin compared with usual diabetes care, without resulting in severe hypoglycemia or diabetic ketoacidosis events. (Funded by Lions Clubs New Zealand District 202F and others; Australian New Zealand Clinical Trials Registry number, ACTRN12622001454763.)

Effectiveness of shared decision-making for glycaemic control among type 2 diabetes mellitus adult patients: A systematic review and meta-analysis.

In diabetes care and management guidelines, shared decision-making (SDM) implementation is explicitly recommended to help patients and health care providers to make informed shared decisions that enable informed choices and the selection of treatments. Despite widespread calls for SDM to be embedded in health care, there is little evidence to support SDM in the management and care of diabetes. It is still not commonly utilized in routine care settings because its effects remain poorly understood. Hence, the current systematic review and meta-analysis aimed to evaluate the effectiveness of SDM for glycaemic control among type 2 diabetes adult patients. Literature sources were searched in MEDLINE, PubMed, Cochrane library and HINARI bibliographic databases and Google Scholar. When these records were searched and reviewed, the PICO criteria (P: population, I: intervention, C: comparator, and O: outcome) were applied. The extracted data was exported to RevMan software version 5.4 and STATA 17 for further analysis. The mean differences (MD) of glycated hemoglobin (HbA1c) were pooled using a random effect model (REM), and sub-group analysis were performed to evaluate the effect size differences across the duration of the follow-up period, modes of intervention, and baseline glycated hemoglobin level of patient groups. The sensitivity analysis was performed using a leave-one-out meta-analysis to quantify the impact of each study on the overall effect size in mean difference HbA1c%. Finally, the statistically significant MD of HbA1c% between the intervention groups engaged in SDM and control groups received usual care was declared at P ˂0.05, using a 95% confidence interval (CI). In the database search, 425 records were retrieved, with only 17 RCT studies fulfilling the inclusion criteria and were included in the meta-analysis. A total of 5416 subjects were included, out of which 2782(51.4%) were included in trial arms receiving SDM and 2634(48.6%) were included in usual diabetes care. The Higgins (I2) test statistics were calculated to be 59.1%, P = 0.002, indicating statistically significant heterogeneity was observed among the included studies, and REM was used as a remedial to estimate the pooled MD of HbA1c% level between patients who participated in SDM and received usual care. As a result, the pooled MD showed that the SDM significantly lowered HbA1c by 0.14% compared to the usual care (95% CI = [-0.26, -0.02], P = 0.02). SDM significantly decreased the level of HbA1c by 0.14% (95% CI = -0.28, -0.01, P = 0.00) when shared decisions were made in person or face-to-face at the point of care, but there was no statistically significant reduction in HbA1c levels when patients were engaged in online SDM. In patients with poorly controlled glycaemic level (≥ 8%), SDM significantly reduced level of HbA1c by 0.13%, 95% CI = [-0.29, -0.03], P = 0.00. However, significant reduction in HbA1c was not observed in patients with ˂ 8%, HbA1c baseline level. Overall, statistically significant reduction of glycated hemoglobin level was observed among T2DM adult patients who participated in shared decision-making compared to those patients who received diabetes usual care that could lead to improved long-term health outcomes, reducing the risk of diabetes-related complications. Therefore, we strongly suggest that health care providers and policy-makers should integrate SDM into diabetes health care and management, and further study should focus on the level of patients' empowerment, health literacy, and standardization of decision supporting tools to evaluate the effectiveness of SDM in diabetes patients.

Assessing the Scalability of a Community-Based Self-Management Intervention for Older Adults with Diabetes and other Chronic Conditions – The Aging, Community and Health Research Unit Community Partnership Program (ACHRU-CPP)

Background: A multi-pronged approach was undertaken to assess the scalability of the Aging, Community and Health Research Unit – Community Partnership Program (ACHRU-CPP), a complex, integrated 6-month self-management program for community-living older adults with diabetes and multimorbidity and their caregivers, in two Canadian provinces. The ACHRU-CPP was co-designed by patients, caregivers, home and community-care providers, and researchers, in response to a gap identified by older adults in the self-management of their diabetes and other conditions. The intervention was tested in a feasibility study and an earlier pragmatic trial found that older adults who received the ACHRU-CPP experienced greater improvements in quality of life and self-management, and greater reduction in depressive symptoms, compared to those who received usual diabetes care, at no additional cost to society. Delivered by a collaborative team of primary care providers (registered nurses, registered dietitians) and a community program coordinator, key components include home visits, group wellness sessions, team-based case conferences, caregiver support, interprofessional collaboration, and nurse-led care coordination. Scalability assessment is an integral phase of the current research program, which evaluated the effectiveness and implementation of the ACHRU-CPP in four settings in Ontario (ON) and Prince Edward Island (PEI).&#x0D; Methods: Multiple methods were used to assess scalability of the ACHRU-CPP in ON and PEI: an environmental scan, individual key informant interviews, and qualitative and quantitative data from both the foundational studies and the current trial of ACHRU-CPP implementation and effectiveness. The Intervention Scalability Assessment Tool (ISAT) guided data collection and analysis. The environmental scan was conducted with strategic input from Scalability Working Groups in ON and PEI. These groups were comprised of members of the program’s governance structure, including patient and public research partners, researchers, primary care and community service providers and administrators, and policy- and decision-makers. These partners advised on relevant research and policy documents, identified potential key informants (i.e., policy- and decision-makers at the local, provincial, and national levels), and will participate in scalability assessment workshops in ON and PEI in late 2022, to finalize the scalability assessment, and identify components of the intervention to be strengthened, and barriers to be addressed to enhance the scalability of the program, in each province.&#x0D; &#x0D; Results: To date, the results of the scalability assessment have identified areas of strength and limitations within the program, most notably issues with health human resources, mixed results regarding the effectiveness of the program, and other resource gaps.&#x0D; Conclusion: This study has evaluated the scalability of a community-based program for older adults with diabetes and multiple chronic conditions that integrates primary and community care. It also provides valuable insight on the usefulness and feasibility of the ISAT for assessing scalability, as well as strategies to engage strategic practice, policy, and public partners in the process. &#x0D; Next steps: While scale-up of the ACHRU-CPP may be merited due to the prevalence of diabetes and multimorbidity among older adults, and alignment of this program with health policy, several barriers need to be addressed before scale-up can be recommended.&#x0D;

Mobile Health Intervention in Patients With Type 2 Diabetes

Clinical pharmacists and health coaches using mobile health (mHealth) tools, such as telehealth and text messaging, may improve blood glucose levels in African American and Latinx populations with type 2 diabetes. To determine whether clinical pharmacists and health coaches using mHealth tools can improve hemoglobin A1c (HbA1c) levels. This randomized clinical trial included 221 African American or Latinx patients with type 2 diabetes and elevated HbA1c (≥8%) from an academic medical center in Chicago. Adult patients aged 21 to 75 years were enrolled and randomized from March 23, 2017, through January 8, 2020. Patients randomized to the intervention group received mHealth diabetes support for 1 year followed by monitored usual diabetes care during a second year (follow-up duration, 24 months). Those randomized to the waiting list control group received usual diabetes care for 1 year followed by the mHealth diabetes intervention during a second year. The mHealth diabetes intervention included remote support (eg, review of glucose levels and medication intensification) from clinical pharmacists via a video telehealth platform. Health coach activities (eg, addressing barriers to medication use and assisting pharmacists in medication reconciliation and telehealth) occurred in person at participant homes and via phone calls and text messaging. Usual diabetes care comprised routine health care from patients' primary care physicians, including medication reconciliation and adjustment. Outcomes included HbA1c (primary outcome), blood pressure, cholesterol, body mass index, health-related quality of life, diabetes distress, diabetes self-efficacy, depressive symptoms, social support, medication-taking behavior, and diabetes self-care measured every 6 months. Among the 221 participants (mean [SD] age, 55.2 [9.5] years; 154 women [69.7%], 148 African American adults [67.0%], and 73 Latinx adults [33.0%]), the baseline mean (SD) HbA1c level was 9.23% (1.53%). Over the initial 12 months, HbA1c improved by a mean of -0.79 percentage points in the intervention group compared with -0.24 percentage points in the waiting list control group (treatment effect, -0.62; 95% CI, -1.04 to -0.19; P = .005). Over the subsequent 12 months, a significant change in HbA1c was observed in the waiting list control group after they received the same intervention (mean change, -0.57 percentage points; P = .002), while the intervention group maintained benefit (mean change, 0.17 percentage points; P = .35). No between-group differences were found in adjusted models for secondary outcomes. In this randomized clinical trial, HbA1c levels improved among African American and Latinx adults with type 2 diabetes. These findings suggest that a clinical pharmacist and health coach-delivered mobile health intervention can improve blood glucose levels in African American and Latinx populations and may help reduce racial and ethnic disparities. ClinicalTrials.gov Identifier: NCT02990299.

Improving Metabolic Syndrome in Ghanaian Adults with Type 2 Diabetes through a Home-Based Physical Activity Program: A Feasibility Randomised Controlled Trial

There is a high prevalence of metabolic syndrome (MetS) among people with type 2 diabetes mellitus (T2DM). Physical activity has the potential to improve health outcomes for individuals with type 2 diabetes. Our study aim was to determine the effect of a 12-week culturally appropriate home-based physical activity program on metabolic syndrome markers and quality of life in Ghanaian adults with T2DM. A secondary objective was to examine the feasibility of implementing the PA program. A feasibility randomised controlled trial (RCT) was conducted. A purposive sample of 87 adults with T2DM at the Korle-Bu Teaching Hospital, Ghana, were randomized into either the control group (CG) (n = 43) or the intervention group (IG) (n = 44). Participants in the IG received the physical activity program in addition to their usual diabetes care; those in the CG received their usual diabetes care. Measurements for feasibility, MetS markers, and quality of life (SF-12) were performed at baseline and 12-week follow-up. Following the 12-week program, participants in the IG showed a significant improvement in fasting blood glucose (2.4% vs. 0.4%, p < 0.05), waist circumference (5.4% vs. 0.4%, p < 0.05), and systolic blood pressure (9.8% vs. 1.5%, p < 0.05). There were no statistical differences between the IG and CG regarding high-density lipoprotein, triglycerides, and diastolic blood pressure at the 12-week follow-up. Classification of MetS were reduced in the IG compared to the CG (51.2% vs. 83.3%, p < 0.05). The MetS severity score improved in the IG compared to the CG (8.8% vs. 0.5%, p < 0.05). The IG improved in two of the eight SF-12 dimensions (physical function and vitality, p < 0.05) compared to the CG. Thirty-two (72.7%) participants completed all 36 exercise sessions. Another 11 (25%) participants completed 80% of the exercise sessions. No adverse events were reported. In conclusion, a 12-week home-based physical activity program is feasible and safe. The intervention has the potential to improve MetS and quality of life in Ghanaian adults with T2DM. The preliminary findings of this study need to be confirmed in a large-scale multi-centre RCT.

Residual β-cell function in Brazilian Type 1 diabetes after 3 years of diagnosis: prevalence and association with low presence of nephropathy

BackgroundPersistence of β cell-function in Type 1 diabetes (T1D) is associated with glycaemia stability and lower prevalence of microvascular complications. We aimed to assess the prevalence of residual C- peptide secretion in long-term Brazilian childhood onset T1D receiving usual diabetes care and its association to clinical, metabolic variables and microvascular complications.MethodsA cross-sectional observational study with 138 T1D adults with ≥ 3 years from the diagnosis by routine diabetes care. Clinical, metabolic variables and microvascular complications were compared between positive ultra-sensitive fasting serum C-peptide (FCP +) and negative (FCP-) participants.ResultsT1D studied had ≥ 3 yrs. of diagnosis and 60% had FCP > 1.15 pmol/L. FCP + T1D were older at diagnosis (10 vs 8 y.o; p = 0.03) and had less duration of diabetes (11 vs 15 y.o; p = 0.002). There was no association between the FCP + and other clinical and metabolic variable but there was inversely association with microalbuminuria (28.6% vs 13.4%, p = 0.03), regardless of HbA1c. FCP > 47 pmol/L were associated with nephropathy protection but were not related to others microvascular complications.ConclusionResidual insulin secretion is present in 60% of T1D with ≥ 3 years of diagnosis in routine diabetes care. FCP + was positively associated with age of diagnosis and negatively with duration of disease and microalbuminuria, regardless of HbA1c.

Diabetes Technology and the Human Factor.

Diabetes Technology and the Human Factor.

Stories for change protocol: A randomized controlled trial of a digital storytelling intervention for Hispanic/Latino individuals with type 2 diabetes

BackgroundHispanic/Latino adults are disproportionately impacted by type 2 diabetes mellitus (T2D). The Stories for Change (S4C) Diabetes digital storytelling intervention promotes T2D self-management among Hispanic/Latino people. We describe the S4C protocol and participant baseline characteristics. MethodsStudy eligibility criteria: Hispanic or Latino, age 18–70 years, ≥1 office visit within a year at a participating clinic, T2D diagnosis for ≥6 months, HbA1c ≥ 8%, and intention to continue care at the recruitment clinic. We used a two-group, parallel randomized controlled trial design and an intervention derived through a community-based participatory research approach. All participants received usual diabetes care and two cards describing how to engage healthcare teams and access diabetes-related resources. At baseline, the intervention group additionally viewed the 12-min, intervention video (four stories about diabetes self-management). To encourage subsequent video viewing, participants received five monthly text messages. The messages prompted them to self-rate their motivation and self-efficacy for T2D management. The control group received no additional intervention. Bilingual (English/Spanish) staff collected data at baseline, six weeks, three months, and six months including biometric measurements and a survey on diabetes self-management outcomes, theory-based measures, and the number of video views. We reviewed the number of diabetes-related appointments attended using electronic medical record data. ResultsParticipants (n = 451; 70% women, mean age = 53 years) had an average HbA1C ≥9%. Intervention participants reported identifying with the storytellers and engaging with the stories. ConclusionWe present a digital storytelling intervention protocol that provides a template for future health promotion interventions prioritizing health disparity populations.ClinicalTrial.gov#NCT03766438

Participants' and Health Care Providers' Insights Regarding a Web-Based and Mobile-Delivered Healthy Eating Program for Disadvantaged People With Type 2 Diabetes: Descriptive Qualitative Study.

Healthy eating is a key element of type 2 diabetes (T2D) self-management. Digital interventions offer new avenues to reach broad audiences to promote healthy eating behaviors. However, acceptance of these interventions by socioeconomically disadvantaged people (eg, those with lower levels of education and income or from ethnic minority groups) has not yet been fully evaluated. This study aimed to investigate the acceptability and usability of EatSmart, a 12-week web-based and mobile-delivered healthy eating behavior change support program, from the perspective of intervention participants living with T2D and health care providers (HCPs) involved in diabetes care. This study used a qualitative descriptive design. Overall, 60 disadvantaged adults with T2D, as determined by receipt of either a HealthCare Card or a pension or benefit as the main source of income, were recruited. Data from participants regarding their experiences with and perceptions of the program and longer-term maintenance of any behavior or attitudinal changes were collected through a web-based self-report survey with open-ended questions administered 12 weeks after baseline (54/60, 90%) and semistructured telephone interviews administered 36 weeks after baseline (16/60, 27%). Supplementary semistructured interviews with 6 HCPs involved in diabetes care (endocrinologists, accredited practicing dietitians, and diabetes nurse educators) were also conducted 36 weeks after baseline. These interviews aimed to understand HCPs' views on successful and unsuccessful elements of EatSmart as a technology-delivered intervention; any concerns or barriers regarding the use of these types of interventions; and feedback from their interactions with patients on the intervention's content, impact, or observed benefits. All data from the surveys and interviews were pooled and thematically analyzed. In total, 5 key themes emerged from the data: program impact on food-related behaviors and routines, satisfaction with the program, reasons for low engagement and suggestions for future programs, benefits and challenges of digital interventions, and cultural considerations. Results showed that EatSmart was acceptable to participants and contributed positively to improving food-related behaviors. Most participants (27/43, 63%) mentioned that they enjoyed their experience with EatSmart and expressed high satisfaction with its content and delivery. The educational and motivational content was considered the most useful part of the program. Benefits discussed by intervention participants included gaining health knowledge and skills, positive changes in their food purchasing and cooking, and eating greater quantities and varieties of fruits and vegetables. HCPs also described the intervention as beneficial and persuasive for the target audience and had specific suggestions for future tailoring of such programs. The findings suggested that this digitally delivered intervention with supportive educational modules and SMS text messages was generally appealing for both participants and HCPs. This intervention medium shows promise and could feasibly be rolled out on a broader scale to augment usual diabetes care. RR2-10.2196/19488.

Effectiveness of Diabetes Self-Management Education on Distress and HbA1C among Indian Type 2 Diabetes Mellitus Patients: A Randomized Controlled Trial.

The interrelationship of diabetes with mental illness has increased in recent years. Diabetes-related distress is the emotional burden, stress, and worries associated with diabetes, which does not reach the threshold for depressive disorder. A diabetes self-management education (DSME) is a structured educational approach to improve glycemic control and diabetes-related distress. This study aimed to assess the effectiveness of DSME in comparison with usual diabetes care in improving glycemic control and diabetes-related distress. This is a single-center, parallel randomized controlled trial. A total of 106 participants were recruited for both intervention and control groups with 53 participants each. The control group received only routine outpatient department (OPD) care. The intervention group received DSME in addition to routine OPD care. Diabetes-related distress and HbA1C were assessed after 3 months. The data were analyzed using IBM Statistical Package for the Social Sciences (SPSS) version 25. Per-protocol analysis was done. Of 127 patients screened, 106 met the eligibility criteria and were randomized. At 3-month follow-up, the reduction in mean HbA1C, fasting blood sugar (FBS), postprandial blood sugar (PPBS), and diabetes distress were significant in the intervention group compared with the control group (p 0.001). The mean HbA1C reduction in the intervention group was significant (mean difference: -1.3, SD: 0.4). The mean DDS had decreased significantly in the intervention group from 2 to 1.2 (mean difference: -0.8, SD: 0.1). The DSME was effective in improving the glycemic control, diabetes-related distress, and self-care among type 2 diabetes (T2DM) mellitus patients.

Telemedicine for Diabetes in Norway.

Telemedicine can be useful for diabetes patients living remotely, especially during pandemic times. We aimed to identify current knowledge of the use of telemedicine for diabetes in Norway by conducting a review of the literature. Telemedicine is mostly beneficial, and it seems that it can be adopted into the usual diabetes care in Norway as a low-cost alternative.

The Long-Term Effects of Non-Pharmacological Interventions on Diabetes and Chronic Complication Outcomes in Patients With Hyperglycemia: A Systematic Review and Meta-Analysis.

ObjectiveThis study aimed at examining the long-term effects of non-pharmacological interventions on reducing the diabetes incidence among patients with prediabetes and chronic complications events among patients with hyperglycemia (pre-diabetes and diabetes) by performing a systematic review and meta-analysis of randomized controlled trials (RCTs).MethodsPubMed, MEDLINE, EMBASE, the Cochrane Library, and the Web of Science Core Collection were searched for studies published between January 1990 and November 2021, looking for RCTs to evaluate the effects of non-pharmacological interventions on preventing the incidence of diabetes and chronic complications in comparison with medical therapy, placebo, or usual diabetes care. Two independent reviews extracted relevant data and quality assessment. Any discrepancies were resolved by a third reviewer.ResultsIn total, 20 articles involved 16 RCTs (follow-up ranged from 2 to 30 years) were included. Pooled analysis of intervention studies demonstrated clearly that non-pharmacological interventions have a significant effect on reducing the diabetes events in patients with prediabetes (RR 0.62; 95% CI 0.54, 0.71). Pooled analysis of extended follow-up studies showed that non-pharmacological interventions could effectively reduce the diabetes incidence in patients with prediabetes (RR 0.78; 95% CI 0.63, 0.96). Meta-regression and subgroup analysis indicates that the diabetes incidence of the long-term group (duration > 3 years) was clearly reduced by 0.05% compared with the relatively short-term group (duration ≤ 3 years). The incidence of microvascular complications in patients with hyperglycemia was effectively lowered by non-pharmacological interventions (RR 0.60; 95% CI 0.43, 0.83).ConclusionNon-pharmacological interventions have a long-term effect on reducing the diabetes incidence among prediabetic patients and effectively preventing microvascular complications on hyperglycemia.Systematic Review Registration https://www.crd.york.ac.uk/prospero/.

The effect of do-it-yourself real-time continuous glucose monitoring on psychological and glycemic variables in children with type 1 diabetes: A randomized crossover trial.

BackgroundContinuous glucose monitoring (CGM) decreases fear of hypoglycemia (FOH) and improves glycemic control among those affected by type 1 diabetes (T1D). No studies to date have examined the impact of using do‐it‐yourself real‐time continuous glucose monitoring (DIY RT‐CGM) on psychological and glycemic outcomes.MethodsChild–parent dyads were recruited for a multicentre randomized crossover trial. Children with T1D were current intermittently scanned CGM (isCGM) users and aged 2–13 years. Families received either 6 weeks of DIY RT‐CGM with parental remote monitoring (intervention) or 6 weeks of isCGM plus usual diabetes care (control), followed by a 4‐week washout period, then crossed over. The primary outcome was parental FOH. Secondary outcomes were glycemic control using traditional CGM metrics, as well as a range of other psychosocial measures.FindingsFifty five child–parent dyads were recruited. The child mean age was 9.1 ± 2.8 years. Although, there was no effect on parental FOH, −0.1 (95%CI: −0.3, 0.1, p = 0.4), time‐in‐range (TIR) (%3.9‐10 mmol/L) was significantly higher with DIY RT‐CGM over isCGM (54.3% ± 13.7 vs. 48.1% ± 13.6), mean difference, 5.7% (95%CI 1.8, 9.6, p <0.004). There was no difference for time spent in hypoglycemia. Parent diabetes treatment satisfaction was significantly higher following DIY RT‐CGM compared to isCGM, mean difference 5.3 (95%CI: 2.3, 8.2, p <0.001).ConclusionThe use of DIY RT‐CGM versus isCGM did not improve parental FOH; however, TIR and parental satisfaction with diabetes treatment were significantly improved. This suggests in the short term, DIY RT‐CGM appears safe and may offer families some clinically important advantages over isCGM.

Effects of an integrated mindfulness intervention for veterans with diabetes distress: a randomized controlled trial.

IntroductionUS military veterans have disproportionately high rates of diabetes and diabetes-related morbidity in addition to being at risk of comorbid stress-related conditions. This study aimed to examine the effects of a technology-supported mindfulness intervention integrated into usual diabetes care and education on psychological and biobehavioral outcomes.Research design and methodsVeterans (N=132) with type 1 or 2 diabetes participated in this two-arm randomized controlled efficacy trial. The intervention arm received a one-session mindfulness intervention integrated into a pre-existing program of diabetes self-management education and support (DSMES) plus one booster session and 24 weeks of home practice supported by a mobile application. The control arm received one 3-hour comprehensive DSMES group session. The primary outcome was change in diabetes distress (DD). The secondary outcomes were diabetes self-care behaviors, diabetes self-efficacy, post-traumatic stress disorder (PTSD), depression, mindfulness, hemoglobin A1C (HbA1C), body weight, and blood pressure. Assessments were conducted at baseline, 12 weeks, and 24 weeks. Participant satisfaction and engagement in home practice were assessed in the intervention group at 12 and 24 weeks.ResultsIntention-to-treat group by time analyses showed a statistically significant improvement in DD in both arms without significant intervention effect from baseline to 24 weeks. Examination of distal effects on DD between weeks 12 and 24 showed significantly greater improvement in the intervention arm. Improvement in DD was greater when baseline HbA1C was <8.5%. A significant intervention effect was also shown for general dietary behaviors. The secondary outcomes diabetes self-efficacy, PTSD, depression, and HbA1C significantly improved in both arms without significant intervention effects. Mindfulness and body weight were unchanged in either group.ConclusionsA technology-supported mindfulness intervention integrated with DSMES showed stronger distal effects on DD compared with DSMES control. Examination of longer-term outcomes, underlying mechanisms, and the feasibility of virtual delivery is warranted.Trial registration numberNCT02928952.

Feasibility of Virtual Simulation-Based Diabetes Foot Care Education in Patients with Diabetes in Ethiopia: Protocol for a Randomized Controlled Trial.

IntroductionDiabetes mellitus is a rapidly growing global public health problem; the number of adults with diabetes is expected to increase from 424.9 million in 2017 to 628.6 million in 2045. Approximately 80% of diabetic patients live in low- and middle-income countries where access to care may be limited. For example, in Ethiopia, diabetes care is often rudimentary, and formal, structured diabetes education is almost non-existent. One potential solution to the lack of diabetes management education for patients could be virtual simulation-based diabetes education incorporating the contextual realities of patients in Ethiopia. Despite its great potential to improve glycemic control, delay diabetes-related complications and reduce mortality associated with diabetes, the feasibility of virtual simulation-based diabetes self-management education has not been studied in low- and middle-income settings.ObjectiveThe purpose of the current study is to evaluate the feasibility of a virtual simulation-based Diabetes Foot Care Education (DFCE) program among adult patients with diabetes in Ethiopia.MethodsA randomized controlled feasibility study including participants from University of Gondar Referral Hospital (UoGRH) will be conducted. A sample of 40 participants will be recruited, of which 20 participants will receive the virtual simulation-based education program, and the other 20 participants will continue with their usual diabetes care. After the education program, a questionnaire and structured interview will be used to explore the feasibility (acceptability, practicality) and the potential impact of virtual simulation-based DFCE intervention in patients with diabetes. Data will be analyzed using SPSS version 25 using descriptive statistics, independent t-tests, paired sample t-test, and factorial ANOVA at significance levels of less than 0.05.DiscussionOur study seeks to understand the perceived usefullness and usability of virtual simulation-based diabetes foot care education on behavioural (diabetes foot-care knowledge, foot self-care practices, and foot self-care efficacy). Furthermore, the study will provide insight to assist in the development of technologically assisted and contextually designed DFCE programs.Trial Registration NumberNCT04841291 (ClinicalTrials.gov Identifier).

Patient, physician, and health system factors associated with five types of inadequate care during management of type-2 diabetes mellitus in the United States

AimsNon-adherence to evidence-based guidelines is major issue when managing type 2 diabetes mellitus (T2DM) that can result in increased risk of diabetes-related complications. This study aims to examine the predictors of inadequate T2DM care, incorporating patient, physician, and health system factors. MethodsA retrospective longitudinal analysis using year 2016–2018 Medical Expenditure Panel Survey data was conducted. Inadequate Care was defined using American Diabetes Association (ADA) Standards of Diabetes guidelines, resulting in five categories: immunization, pharmacologic therapy, lifestyle management, laboratory evaluation, and physical examination. A logistic regression model was used to estimate effects of patient, physician, and health systems factors on inadequate care. ResultsThe study cohort consisted of 1,491 individuals, representing 14,379,304 individuals. Prevalence of inadequate care was estimated at 27%, 44%, 24%, 31%, and 25% of inadequate care for metrics immunization, pharmacologic therapy, lifestyle management, laboratory evaluation, and physical examination, respectively. Fourteen out of 19 of the predictors measured were associated with at least one category of inadequate care. ConclusionsInadequate T2DM care is an extensive issue, with a variety of associated factors, including patient, physician, and health system factors. Some characteristics, including diabetes complications severity index, insurance type, poverty level, and usual diabetes care facility were associated with over a 100% increase in inadequate care received. The study findings may inform the development of intervention programs to improve adherence to ADA guidelines on T2D management.

Design of a randomized controlled trial of digital health and community health worker support for diabetes management among low-income patients

BackgroundInsulin-dependent diabetes is a challenging disease to manage and involves complex behaviors, such as self-monitoring of blood glucose. This can be especially challenging in the face of socioeconomic barriers and in the wake of the COVID-19 pandemic. Digital health self-monitoring interventions and community health worker support are promising and complementary best practices for improving diabetes-related health behaviors and outcomes. Yet, these strategies have not been tested in combination. This protocol paper describes the rationale and design of a trial that measures the combined effect of digital health and community health worker support on glucose self-monitoring and glycosylated hemoglobin. MethodsThe study population was uninsured or publicly insured; lived in high-poverty, urban neighborhoods; and had poorly controlled diabetes mellitus with insulin dependence. The study consisted of three arms: usual diabetes care; digital health self-monitoring; or combined digital health and community health worker support. The primary outcome was adherence to blood glucose self-monitoring. The exploratory outcome was change in glycosylated hemoglobin. ConclusionThe design of this trial was grounded in social justice and community engagement. The study protocols were designed in collaboration with frontline community health workers, the study aim was explicit about furthering knowledge useful for advancing health equity, and the population was focused on low-income people. This trial will advance knowledge of whether combining digital health and community health worker interventions can improve glucose self-monitoring and diabetes-related outcomes in a high-risk population.

Study protocol: behaviour change intervention to promote healthy diet and physical activity in overweight/obese adults with diabetes attending health care facilities in Muscat: a cluster rendomised control trial

BackgroundHealthy behavior is an essential component in type 2 diabetes (T2D) management. Promoting healthy lifestyle is one of the priorities of primary health care in Oman. This study aims to evaluate the effectiveness of a multi-component intervention in promoting physical activity (PA) and healthy diet and its implications on body mass index and glycemic control in adults with diabetes attending primary care.MethodsA one year 1:1 cluster randomized controlled trial will be utilized to compare the use of phone consultations, a multi component interactive phone application and pedometers with the usual diabetes care on promoting PA and healthy diet. Participants will be screened for inactivity and should be T2D, aged18–65 years, and overweight or obese. Eight primary centers will be randomly selected in each arm (n = 375). The primary outcome is the between arms differences in PA and diet scores, BMI and HbA1c over 12 months from baseline. Additionally, secondary outcomes will include cardiovascular outcomes (BP, and lipids).The trial has received ethical approval from the Omani Research and Ethical Review and Approval Committee. All eligible participants will be invited to their respected health centers to provide informed consent.DiscussionThis study will contribute to the integration of healthy lifestyle approach using artificial intelligence to primary diabetes care. Results from this study will be disseminated through workshops, policy briefs, and peer-reviewed publications, local and international conferences.Trial registrationTrial registration number ISRCTN71889430. Date applied: 28/11/2020. Date assigned: 01/12/2020.

Effects of a low-carbohydrate diet in adults with type 1 diabetes: an interventional study protocol

&lt;p&gt;&lt;strong&gt;Background:&lt;/strong&gt; Type 1 diabetes (T1D) is an autoimmune condition characterised by pancreatic beta cell destruction and absolute insulin deficiency. The varying impact of dietary factors on blood glucose levels is well-known, yet there remains a lack of consensus surrounding the optimal dietary approaches to achieve glycaemic control in T1D. The aim of this research is to assess the efficacy of a low-carbohydrate (LC) diet in adults with T1D. We will set out to determine whether significant differences in T1D management outcomes exist between a LC diet and habitual diets higher in carbohydrate. Our primary hypothesis is that a LC diet will result in improved T1D management compared to habitual diets higher in carbohydrates. &lt;strong&gt;&lt;/strong&gt;&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods:&lt;/strong&gt; This is a 28-week single arm within-participant intervention study involving a 4-week control period, a 12-week intervention period and a 12-week follow-up. We plan to recruit 20 adults (18-60 years) with T1D (duration ≥6 months) who have suboptimal glycaemic control (HbA1c&amp;gt;7.0%). The primary outcome is haemoglobin A1c (HbA1c) and secondary outcomes include glycaemic variability, frequency of hypoglycaemia, total daily insulin, and quality of life. This LC diet will start at 50 g of digestible carbohydrate per day and then there will be opportunity to increase or decrease within a broader range of 25-75 g/day according to individual blood glucose levels and personal preference. Participants will meet individually with the study dietitian for a total of six fortnightly sessions to receive dietary instruction, strategies, and education. Participants will continue to work with a member of their usual diabetes care team for specific advice regarding insulin management.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt;&lt;em&gt; &lt;/em&gt;Current dietary management strategies for T1D appear to be lacking in effect and additional dietary therapies, including LC diets, require urgent consideration. Therefore, an interventional study investigating a patient-led LC dietary approach will be of important clinical relevance for healthcare practitioners and may help to better inform clinical practice guidelines for T1D management.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial Registration&lt;em&gt;: &lt;/em&gt;&lt;/strong&gt;https://www.anzctr.org.au/ACTRN12621000764831.aspx &lt;em&gt;&lt;/em&gt;&lt;/p&gt;