Personalized Behavioral Nutrition Intervention in Older Asian Americans with Type 2 Diabetes during COVID-19 Pandemic: Study Protocol for a Pilot, Hybrid, Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Jisook Ko ◽  
Yan Du ◽  
Rozmin Jiwani ◽  
Chengdong Li ◽  
Jing Wang
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Pilot Study ◽  
Glycemic Control ◽  
Asian Americans ◽  
Control Group ◽  
Management Approach ◽  
Self Monitoring ◽  
Behavioral Nutrition

BACKGROUND The COVID-19 pandemic has challenged the in-person-based self-management approach (i.e., face-to-face or group approach) of type 2 diabetes (T2D). Older adults with T2D, including Asian Americans (AAs), have experienced worsening of diabetes control due to various reasons, including uncertainty of continuous access to essential diabetes medications, devices, education, limited health literacy, as well as constant anxiety and stress. Hybrid clinical trials that incorporate virtual elements into the in-person-based study could provide these vulnerable populations with accessible and timely interventions OBJECTIVE The primary aims of this pilot study are to determine (1) the effect of personalized behavioral nutrition (PBN) intervention on glycemic control, weight control, and metabolites profiles; and (2) the acceptability of PBN. to enhance glycemic control using personalized behavioral nutrition. METHODS Participants will be recruited with a web-based registry, advertisements in ethnic newspapers, and social network services popular among AAs. A total of 60 AAs, aged 65 years or older, who are descendants of Chinese, Korean, or South Asian, and have a diagnosis of T2D will be randomized into two groups: a PBN group (n=30) and a control group (n=30). A 4-week PBN intervention comprises three components: 1) digital self-monitoring; 2) personal nutrition change goals and recommendations; and 3) diabetes nutrition educations. All participants will complete digital self-monitoring on diet, physical activity, and blood glucose. In addition, all participants will access an interactive digital platform to track their self-monitoring data and communicate with the research team. The effectiveness and acceptability of implementing the intervention will be assessed. RESULTS Funding support and institutional review board approval for this study have been secured. Data collection started in August 2020 and is ongoing. CONCLUSIONS To our knowledge, this is the first study to determine the effectiveness and acceptability of PBN utilizing a metabolomics approach and digital-assisted intervention with hybrid RCT among older AAs. The findings of this pilot study will inform the development of a full-scale PBN protocol and hybrid clinical trials that can be adapted for people with T2D in the ongoing pandemic.

scholarly journals The effects of professional continuous glucose monitoring as an adjuvant educational tool for improving glycemic control in patients with type 2 diabetes

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Dulce Adelaida Rivera-Ávila ◽  
Alejandro Iván Esquivel-Lu ◽  
Carlos Rafael Salazar-Lozano ◽  
Kyla Jones ◽  
Svetlana V. Doubova
Keyword(s):  
Type 2 Diabetes ◽  
Glycemic Control ◽  
Continuous Glucose Monitoring ◽  
Glucose Monitoring ◽  
Outcome Variable ◽  
Control Group ◽  
Educational Tool ◽  
Study Objective ◽  
Hba1c Levels

Abstract Background The study objective was to evaluate the effects of professional continuous glucose monitoring (CGM) as an adjuvant educational tool for improving glycemic control in patients with type 2 diabetes (T2D). Methods We conducted a three-month quasi-experimental study with an intervention (IGr) and control group (CGr) and ex-ante and ex-post evaluations in one family medicine clinic in Mexico City. Participants were T2D patients with HbA1c > 8% attending a comprehensive diabetes care program. In addition to the program, the IGr wore a professional CGM sensor (iPro™2) during the first 7 days of the study. Following this period, IGr participants had a medical consultation for the CGM results and treatment adjustments. Additionally, they received an educational session and personalized diet plan from a dietitian. After 3 months, the IGr again wore the CGM sensor for 1 week. The primary outcome variable was HbA1c level measured at baseline and 3 months after the CGM intervention. We analyzed the effect of the intervention on HbA1c levels by estimating the differences-in-differences treatment effect (Diff-in-Diff). Additionally, baseline and three-month CGM and dietary information were recorded for the IGr and analyzed using the Student’s paired t-test and mixed-effects generalized linear models to control for patients’ baseline characteristics. Results Overall, 302 T2D patients participated in the study (IGr, n = 150; control, n = 152). At the end of the three-month follow-up, we observed 0.439 mean HbA1C difference between groups (p = 0.004), with an additional decrease in HbA1c levels in the IGr compared with the CGr (Diff-in-Diff HbA1c mean of − 0.481% points, p = 0.023). Moreover, compared with the baseline, the three-month CGM patterns showed a significant increase in the percentage of time in glucose range (+ 7.25; p = 0.011); a reduction in the percentage of time above 180 mg/dl (− 6.01; p = 0.045), a decrease in glycemic variability (− 3.94, p = 0.034); and improvements in dietary patterns, shown by a reduction in total caloric intake (− 197.66 Kcal/day; p = 0.0001). Conclusion Professional CGM contributes to reducing HbA1c levels and is an adjuvant educational tool that can improve glycemic control in patients with T2D. Trial registration ClinicalTrials.gov: NCT04667728. Registered 16/12/2020

Effect of Type 2 Diabetes Mellitus and diabetic medication on Pulmonary Function

2021 ◽  
Vol 17 ◽  
Author(s):  
Alaa M. Hammad ◽  
Waleed Qirim ◽  
Ameen Alassi ◽  
Dana Hyassat
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Glycemic Control ◽  
Pulmonary Function ◽  
Disease Duration ◽  
Linear Regression Analysis ◽  
Forced Expiratory Volume ◽  
Control Group

Background: Type 2 diabetes mellitus (T2DM) is a chronic condition with an impairing effect on multiple organs. Numerous respiratory disorders have been observed in patients with T2DM. However, T2DM e ect on pulmonary function is ff inconclusive. Aims: In this study, we investigated the effect of T2DM on respiratory function and the correlation of glycemic control, diabetes duration and insulin intake. Methods: 1500 patients were recruited for this study, 560 having T2DM for at least a year were included in the final data, in addition to 540 healthy volunteers. Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), forced expiratory flow at 25-75% (FEF 25-75%), as well as FEV1/FVC ratio values were measured. Results: A two-sample t-test showed that z-scores produced by Al-Qerem et al.’s equations for FEV1, FVC, and FEF 25-75% were significantly lower for the T2DM group than the control group (p < 0.01). FEV1/FVC ratio in T2DM group were significantly higher (p < 0.01). Multiple linear regression analysis found that glycemic control represented by HbA1c as well as disease duration were negatively associated with pulmonary function (p < 0.01). However, insulin intake was found to have no significant correlation with the pulmonary function. Conclusion: T2DM was linked to reduced pulmonary function and was consistent with a restrictive ventilation pattern. HbA1c as well as disease duration were independent risk factors for reduced pulmonary function.

Self-Monitoring of Blood glucose(SMBG), Utilization of SMBG, Hypoglycemia Frequency and Glycemic Control in Type 2 Diabetes

2020 ◽  
Vol 32 (2) ◽  
pp. 51-60
Author(s):  
Minja Cho ◽  
Changkwan Lee ◽  
Eunjeong Lee ◽  
Miyoung Kim
Keyword(s):  
Type 2 Diabetes ◽  
Blood Glucose ◽  
Glycemic Control ◽  
Self Monitoring

Recommendations for improving clinical trial design to facilitate the study of youth-onset type 2 diabetes

2019 ◽  
Vol 17 (1) ◽  
pp. 87-98
Author(s):  
Muhammad Yazid Jalaludin ◽  
Margarita Barrientos-Pérez ◽  
Mona Hafez ◽  
Jane Lynch ◽  
Naim Shehadeh ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Control Group ◽  
Onset Type ◽  
Therapeutic Choice ◽  
Glycemic Targets ◽  
Definition Of

Background The prevalence of type 2 diabetes is increasing in youths and differs from adult-onset type 2 diabetes in its characteristics and progression. Currently, only two drugs are approved for youth-onset type 2 diabetes and many patients are not meeting glycemic targets. Clearly, there is an urgent need to complete clinical trials in youths with type 2 diabetes to increase the therapeutic choice for these patients. However, factors such as limited patient numbers, unwillingness of patients to participate in trials, failure to meet strict inclusion and exclusion criteria, and poor clinic attendance have limited the size and number of trials in this complicated patient demographic. Recommendations This is a narrative opinion piece on the design of clinical trials in youth-onset type 2 diabetes prepared by researchers who undertake this type of study in different countries. The review addresses possible ways to enhance trial designs in youth-onset type 2 diabetes to meet regulatory requirements, while minimizing the barriers to patients’ participation. The definition of adolescence, recruitment of sufficient patient numbers, increasing flexibility in selection criteria, improving convenience of trial visits, requirements of a control group, possible endpoints, and trial compliance are all considered. The authors recommend allowing extrapolation from adult data, using multiple interventional arms within future trials, broadening inclusion criteria, and focusing on endpoints beyond glucose control, among others, in order to improve the successful completion of more trials in this population. Conclusions Improvements in trial design will enable better recruitment and retention and thereby more evidence for treatment outcomes for youth-onset type 2 diabetes.

scholarly journals Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial

2020 ◽  
Vol 8 (1) ◽  
pp. e001115 ◽  
Author(s):  
Eri Wada ◽  
Takeshi Onoue ◽  
Tomoko Kobayashi ◽  
Tomoko Handa ◽  
Ayaka Hayase ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Blood Glucose ◽  
Glycemic Control ◽  
Glucose Monitoring ◽  
Analysis Of Covariance ◽  
Self Monitoring ◽  
Flash Glucose Monitoring ◽  
Baseline Values ◽  
The Mean

IntroductionThe present study aimed to evaluate the effects of flash glucose monitoring (FGM) and conventional self-monitoring of blood glucose (SMBG) on glycemic control in patients with non-insulin-treated type 2 diabetes.Research design and methodsIn this 24-week, multicenter, open-label, randomized (1:1), parallel-group study, patients with non-insulin-treated type 2 diabetes at five hospitals in Japan were randomly assigned to the FGM (n=49) or SMBG (n=51) groups and were provided each device for 12 weeks. The primary outcome was change in glycated hemoglobin (HbA1c) level, and was compared using analysis of covariance model that included baseline values and group as covariates.ResultsForty-eight participants in the FGM group and 45 in the SMBG group completed the study. The mean HbA1c levels were 7.83% (62.1 mmol/mol) in the FGM group and 7.84% (62.2 mmol/mol) in the SMBG group at baseline, and the values were reduced in both FGM (−0.43% (−4.7 mmol/mol), p<0.001) and SMBG groups (−0.30% (−3.3 mmol/mol), p=0.001) at 12 weeks. On the other hand, HbA1c was significantly decreased from baseline values in the FGM group, but not in the SMBG group at 24 weeks (FGM: −0.46% (−5.0 mmol/mol), p<0.001; SMBG: −0.17% (−1.8 mmol/mol), p=0.124); a significant between-group difference was also observed (difference −0.29% (−3.2 mmol/mol), p=0.022). Diabetes Treatment Satisfaction Questionnaire score was significantly improved, and the mean glucose levels, SD of glucose, mean amplitude of glycemic excursions and time in hyperglycemia were significantly decreased in the FGM group compared with the SMBG group.ConclusionsGlycemic control was better with FGM than with SMBG after cessation of glucose monitoring in patients with non-insulin-treated type 2 diabetes.Trial registration numberUMIN000026452, jRCTs041180082.

scholarly journals Acute Effect of Acupuncture on Glycemic Control in Type 2 Diabetes Measured by Continuous Glucose Monitoring: A Pilot Study

2020 ◽  
Author(s):  
Sérgio Vencio ◽  
Isabela Caiado-Vencio ◽  
Adriana Caiado ◽  
Douglas Morgental ◽  
Luisa Soares Dantas ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Pilot Study ◽  
Glycemic Control ◽  
Continuous Glucose Monitoring ◽  
Glucose Monitoring ◽  
Acute Effect
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