A Subsidized Healthy Food Prescription Program for Adults With Type 2 Diabetes Who Are Experiencing Food Insecurity: Protocol for a Randomized Controlled Trial

Abstract Objectives It is vital for individuals with type 2 diabetes (T2DM) to adhere to a healthy dietary pattern to maintain optimal blood glucose levels and overall health. Increasing costs of healthy foods, however, are a barrier to maintaining healthful dietary patterns, particularly for individuals with T2DM who are experiencing food insecurity. Poor diet quality may result in difficulties maintaining optimal blood glucose levels, leading to higher rates of diabetes complications, and increased acute care usage and costs. Although the adverse impacts of food insecurity on maintaining optimal blood glucose levels are well documented, effective strategies to this among individuals with T2DM are lacking. One approach is providing subsidies to purchase healthy foods through subsidized healthy food prescription programs. These programs may help reduce food insecurity and improve diet quality, thereby improving blood glucose levels and reducing diabetes complications over time. Methods A parallel group randomized controlled trial will examine the effectiveness of a subsidized healthy food prescription program compared to a healthy food prescription alone in improving average blood glucose levels (primary outcome), and other secondary outcomes among 404 adults who are experiencing food insecurity and persistent hyperglycemia. The subsidized healthy food prescription program consists of two core elements: 1) A one-time healthy food prescription pamphlet that outlines an evidence-based healthy dietary pattern; 2) A healthy food subsidy of $1.50/day/household member to purchase healthy foods in participating supermarkets for 6 months. At baseline and 6-month follow-up, participants will provide responses to sociodemographic and health-related items, and a variety of patient-reported outcomes. Biochemical and physical measurements will also be obtained. Results The study's theory of change posits that reducing food insecurity and improving diet quality will be key mediators in improving blood glucose levels, which may reduce diabetes complications, and healthcare usage and costs over time. Conclusions The results of this study will demonstrate if a subsidized healthy food prescription program results in meaningful changes in average blood glucose levels and other clinically relevant outcomes. Funding Sources Alberta Innovates, Alberta Health Services.

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A Subsidized Healthy Food Prescription Program for Adults with type 2 Diabetes who are Experiencing Food Insecurity: Protocol for a Randomized Controlled Trial, Modelling and Implementation Studies

10.21203/rs.3.rs-180761/v1 ◽

2021 ◽

Author(s):

Dana Lee Olstad ◽

Reed F Beall ◽

Eldon Spackman ◽

Sharlette Dunn ◽

Lorraine Lipscombe ◽

...

Keyword(s):

Food Insecurity ◽

Program Effectiveness ◽

Controlled Trial ◽

Healthy Food ◽

Healthy Foods ◽

Glucose Levels ◽

Randomized Controlled ◽

Blood Glucose Levels ◽

Persistent Hyperglycemia

Abstract Background: The high cost of many healthy foods poses a significant challenge to the maintenance of optimal blood glucose levels for adults with type 2 diabetes (T2DM) who are experiencing food insecurity, leading to diabetes complications and excess acute care usage and costs. Subsidized healthy food prescription programs may help to reduce food insecurity by financially supporting patients to improve their diet quality, prevent diabetes complications and avoid acute care use. This study will use a type 2 hybrid effectiveness-implementation design to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of a subsidized healthy food prescription program for adults who are experiencing food insecurity and persistent hyperglycemia. A randomized controlled trial (RCT) will investigate program effectiveness via impact on blood glucose levels (primary outcome), food insecurity, diet quality and other clinical and patient-reported outcomes. A modelling study will estimate longer-term program effectiveness in reducing diabetes-related complications, resource use and costs. An implementation study will examine all RE-AIM domains, including reasons behind program successes and failures, fidelity, mechanisms of impact, contextual determinants of effective implementation and sustainability. Methods: 404 adults who are experiencing food insecurity and persistent hyperglycemia, including adults who identify as Indigenous, will be randomized to a subsidized healthy food prescription intervention (n=202) or a healthy food prescription comparison group (n=202). Both groups will receive a healthy food prescription. The intervention group will additionally receive $1.50/day/household member to purchase healthy foods in supermarkets for 6 months. The implementation process will follow the Quality Implementation Framework. Outcomes will be assessed at baseline and follow-up (6 months) in the RCT and analyzed using mixed-effects linear and multinomial logistic/ordinal regression models. Longer-term outcomes will be modelled using the validated UK Prospective Diabetes Study outcomes simulation model-2. Implementation processes and outcomes will be continuously measured via quantitative and qualitative data and analyzed using descriptive statistics and theory-informed directed content analysis, respectively. Discussion: This research will provide a comprehensive body of data with high internal and external validity to assist policymakers and practitioners to effectively and rapidly translate the evidence generated into programs and policies to support patients with T2DM who are experiencing food insecurity. Trial registration: ClinicalTrials.gov NCT04725630 (January 25, 2021; https://www.clinicaltrials.gov/ct2/show/NCT04725630?term=Subsidized+Healthy+Food+Prescription+Program&cond=Diabetes+Mellitus%2C+Type+2&draw=2&rank=1).

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Role of Digital Engagement in Diabetes Care Beyond Measurement: Retrospective Cohort Study (Preprint)

10.2196/preprints.24030 ◽

2020 ◽

Author(s):

Yifat Fundoiano-Hershcovitz ◽

Abigail Hirsch ◽

Sharon Dar ◽

Eitan Feniger ◽

Pavel Goldstein

Keyword(s):

Type 2 Diabetes ◽

Blood Glucose ◽

Glucose Levels ◽

Monthly Average ◽

Diabetes Outcomes ◽

Blood Glucose Levels ◽

Average Blood Glucose ◽

Tagging Behavior ◽

Digital Engagement

BACKGROUND The use of remote data capture for monitoring blood glucose and supporting digital apps is becoming the norm in diabetes care. One common goal of such apps is to increase user awareness and engagement with their day-to-day health-related behaviors (digital engagement) in order to improve diabetes outcomes. However, we lack a deep understanding of the complicated association between digital engagement and diabetes outcomes. OBJECTIVE This study investigated the association between digital engagement (operationalized as tagging of behaviors alongside glucose measurements) and the monthly average blood glucose level in persons with type 2 diabetes during the first year of managing their diabetes with a digital chronic disease management platform. We hypothesize that during the first 6 months, blood glucose levels will drop faster and further in patients with increased digital engagement and that difference in outcomes will persist for the remainder of the year. Finally, we hypothesize that disaggregated between- and within-person variabilities in digital engagement will predict individual-level changes in blood glucose levels. METHODS This retrospective real-world analysis followed 998 people with type 2 diabetes who regularly tracked their blood glucose levels with the Dario digital therapeutics platform for chronic diseases. Subjects included “nontaggers” (users who rarely or never used app features to notice and track mealtime, food, exercise, mood, and location, n=585) and “taggers” (users who used these features, n=413) representing increased digital engagement. Within- and between-person variabilities in tagging behavior were disaggregated to reveal the association between tagging behavior and blood glucose levels. The associations between an individual’s tagging behavior in a given month and the monthly average blood glucose level in the following month were analyzed for quasicausal effects. A generalized mixed piecewise statistical framework was applied throughout. RESULTS Analysis revealed significant improvement in the monthly average blood glucose level during the first 6 months (t=−10.01, P<.001), which was maintained during the following 6 months (t=−1.54, P=.12). Moreover, taggers demonstrated a significantly steeper improvement in the initial period relative to nontaggers (t=2.15, P=.03). Additional findings included a within-user quasicausal nonlinear link between tagging behavior and glucose control improvement with a 1-month lag. More specifically, increased tagging behavior in any given month resulted in a 43% improvement in glucose levels in the next month up to a person-specific average in tagging intensity (t=−11.02, P<.001). Above that within-person mean level of digital engagement, glucose levels remained stable but did not show additional improvement with increased tagging (t=0.82, P=.41). When assessed alongside within-person effects, between-person changes in tagging behavior were not associated with changes in monthly average glucose levels (t=1.30, P=.20). CONCLUSIONS This study sheds light on the source of the association between user engagement with a diabetes tracking app and the clinical condition, highlighting the importance of within-person changes versus between-person differences. Our findings underscore the need for and provide a basis for a personalized approach to digital health.

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Association between blood glucose levels and Glasgow Outcome Score in patients with traumatic brain injury: secondary analysis of a randomized trial

Trials ◽

10.1186/s13063-022-06005-5 ◽

2022 ◽

Vol 23 (1) ◽

Author(s):

Tao Yuan ◽

Hongyu He ◽

Yuepeng Liu ◽

Jianwei Wang ◽

Xin Kang ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Blood Glucose ◽

Brain Injury ◽

Blood Glucose Level ◽

Glucose Level ◽

Threshold Effect ◽

Glasgow Outcome Score ◽

Glucose Levels ◽

Blood Glucose Levels ◽

Average Blood Glucose

Abstract Background Blood glucose levels that are too high or too low after traumatic brain injury (TBI) negatively affect patient prognosis. This study aimed to demonstrate the relationship between blood glucose levels and the Glasgow Outcome Score (GOS) in TBI patients. Methods This study was based on a randomized, dual-center, open-label clinical trial. A total of 208 patients who participated in the randomized controlled trial were followed up for 5 years. Information on the disease, laboratory examination, insulin therapy, and surgery for patients with TBI was collected as candidate variables according to clinical importance. Additionally, data on 5-year and 6-month GOS were collected as primary and secondary outcomes, respectively. For multivariate analysis, a generalized additive model (GAM) was used to investigate relationships between blood glucose levels and GOS. The results are presented as odds ratios (ORs) with 95% confidence intervals (95% CIs). We further applied a two- piecewise linear regression model to examine the threshold effect of blood glucose level and GOS. Results A total of 182 patients were included in the final analysis. Multivariate GAM analysis revealed that a bell-shaped relationship existed between average blood glucose level and 5-year GOS score or 6-month GOS score. The inflection points of the average blood glucose level were 8.81 (95% CI: 7.43–9.48) mmol/L considering 5-year GOS as the outcome and were 8.88 (95% CI 7.43−9.74) mmol/L considering 6-month GOS score as the outcome. The same analysis revealed that there was also a bell relationship between average blood glucose levels and the favorable outcome group (GOS score ≥ 4) at 5 years or 6 months. Conclusion In a population of patients with traumatic brain injury, blood glucose levels were associated with the GOS. There was also a threshold effect between blood glucose levels and the GOS. A blood glucose level that is either too high or too low conveys a poor prognosis. Trial registration ClinicalTrials.gov NCT02161055. Registered on 11 June 2014.

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Prevalence of hypoglycemia in diarrheal dehydration at hospitalization in severe acute malnutrition

International Journal of Contemporary Pediatrics ◽

10.18203/2349-3291.ijcp20181549 ◽

2018 ◽

Vol 5 (3) ◽

pp. 1092 ◽

Cited By ~ 1

Author(s):

Rameshwar Ninama ◽

Chakshu Chaudhry ◽

Rameshwar Lal Suman ◽

Suresh Goyal ◽

Ramprakash Prakash Bairwa ◽

...

Keyword(s):

Blood Glucose ◽

Acute Diarrhea ◽

Severe Acute Malnutrition ◽

Cross Sectional Study ◽

Acute Malnutrition ◽

Severe Dehydration ◽

Cross Sectional ◽

Glucose Levels ◽

Blood Glucose Levels ◽

Average Blood Glucose

Background: Diarrhea is the major cause of death in children below five years of age. Hypoglycemia has been a potential fatal complication of infectious diarrhea in both well-nourished and poorly nourished children. But prevalence of hypoglycemia in diarrheal dehydration is not exactly known. This study was done to evaluate the glycemic status in children having acute diarrhea with dehydration and specifically associated with severe acute malnutrition (SAM).Methods: This descriptive cross-sectional study was conducted during July 2017 to December 2017 at Bal Chikitsalaya Udaipur, Rajasthan, India. Blood glucose levels were assessed in 150 children of acute diarrhea with dehydration, comprising of 100 SAM and 50 Non SAM children.Results: Average blood glucose of SAM children was 89 mg/dl and of non-SAM, it was 120 mg/dl. Average blood glucose was low in SAM as compared to non-SAM in both some dehydration (116.08±21.26) and severe dehydration (66.69±19.80) as well as with or without ORS intake. Overall 18 (12%) of children had hypoglycemia and all were in severe dehydration and not taking ORS. Blood glucose levels were statistically low in severe dehydration and those who were not taking ORS at the time of hospitalization (p = 0.001). In severe dehydration 25% of children had hypoglycemia means every fourth child had low blood glucose <54 mg/dl.Conclusions: Overall prevalence of hypoglycemia is 12% in diarrheal dehydration and 20% in SAM with dehydration. Twenty five percent of severe dehydration children had hypoglycemia, and all have not started ORS. None of the child started ORS developed hypoglycaemia.

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Effectiveness of acarbose in treating elderly patients with diabetes with postprandial hypotension

Journal of Investigative Medicine ◽

10.1136/jim-2016-000295 ◽

2017 ◽

Vol 65 (4) ◽

pp. 772-783 ◽

Cited By ~ 5

Author(s):

Jie Zhang ◽

Lixin Guo

Keyword(s):

Blood Pressure ◽

Blood Glucose ◽

Elderly Patients ◽

Controlled Trial ◽

Clinical Trial Registry ◽

Postprandial Hypotension ◽

Glucose Levels ◽

Blood Glucose Levels ◽

Patients With Diabetes ◽

Group B

Postprandial hypotension (PPH) is a common condition that occurs primarily in elderly patients with type 2 diabetes mellitus (T2DM). This study aimed to assess the effectiveness of acarbose for PPH; it also investigated possible mechanisms behind PPH development. This single-blind, randomized controlled trial included 91 elderly patients with T2DM, aged between 60 and 80 years, who were inpatients at Beijing Hospital between March 2012 and November 2014. The patients were included into one of three groups: Group A, patients with T2DM without PPH; Group B, patients with T2DM with PPH receiving placebo; and Group C, patients with T2DM with PPH receiving acarbose. After an overnight fast, patients received a single dose of acarbose (100 mg) or placebo and then consumed a standardized 450 kcal meal. Blood pressure, glucose levels, heart rate (HR), and catecholamine levels were evaluated. Acarbose ameliorated PPH as determined by significant improvements in the duration and maximal fall in blood pressure (both p<0.001); however, no differences in HR and blood glucose levels were observed. In patients with PPH, blood pressure was correlated with blood glucose and HR variability values (p<0.05). Correlations between epinephrine and glucagon-like peptide-1 with blood pressure in groups A and C were largely lost in group B. Acarbose reduced postprandial blood pressure fluctuations in elderly patients with diabetes. PPH may be related to impaired autonomic nervous system function, reduced catecholamine secretion, and postprandial fluctuations in blood glucose levels.Trial registration numberChinese Clinical Trial Registry ChiCTR-IPR-15006177.

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A randomized controlled trial evaluating the effects of tai chi training on indicators of glycaemic control and insulin resistance in adults with raised blood glucose levels

Journal of Science and Medicine in Sport ◽

10.1016/j.jsams.2009.10.441 ◽

2010 ◽

Vol 12 ◽

pp. e210-e211

Author(s):

L. Xin ◽

N. Burton ◽

W. Brown

Keyword(s):

Insulin Resistance ◽

Randomized Controlled Trial ◽

Blood Glucose ◽

Glycaemic Control ◽

Tai Chi ◽

Controlled Trial ◽

Glucose Levels ◽

Randomized Controlled ◽

Blood Glucose Levels

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Gambaran Kadar Glukosa Darah Sewaktu Pada Penderita Hipertensi di Puskesmas II Mendoyo

Jurnal Analis Kesehatan ◽

10.26630/jak.v10i2.2956 ◽

2021 ◽

Vol 10 (2) ◽

pp. 75

Author(s):

I Gusti Agung Dewi Sarihati ◽

Putu Dita Pratiwi ◽

I Gusti Agung Ayu Putu Swastini

Keyword(s):

Diabetes Mellitus ◽

Insulin Resistance ◽

Blood Glucose ◽

Data Collection ◽

Quantitative Method ◽

Sampling Technique ◽

Glucose Levels ◽

Blood Glucose Levels ◽

Average Blood Glucose ◽

Diabetes Melitus

Description of Blood Glucose Levels in Hypertension Patients in Mendoyo Public Health Center Abstract Hypertension is a degenerative disease that still affects many people in Bali Province. Hypertension occurs due to many factors where it can start from genetics and lifestyle. Hypertension can lead to insulin resistance which is the main cause of increased blood glucose, so that people who suffer from hypertension have the risk of suffering from diabetes mellitus. The purpose of this study is to describe the current blood glucose levels in patients with hypertension at Puskesmas II Mendoyo. Method this research uses descriptive quantitative method involving 30 respondents through purposive sampling technique. The research was conducted in March - April 2021. Data collection was carried out by filling out questionnaires and examining blood glukose level with POCT EasyTouch GCU. The results showed that (13.3%) patients with hypertension had blood glucose levels in the non-DM category, (80%) with the uncertain DM category, and (6.7%) in the DM category. The average blood glucose level is 120.7 mg/dl with the lowest level is 84 mg/dl and the highest level up to 273 mg/dl. In conclusion, most patients with hypertension have blood glucose levels during the uncertain DM category.Keywords: blood glucose levels; hypertension; diabetes melitus

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Association Between Exercise and Blood Glucose Levels In Diabetic Patients

Jurnal Berkala Epidemiologi ◽

10.20473/jbe.v4i22016.188-199 ◽

2017 ◽

Vol 4 (2) ◽

pp. 188

Author(s):

Eryna Laili Putri

Keyword(s):

Diabetes Mellitus ◽

Blood Glucose ◽

Control Group ◽

Case Group ◽

Diabetic Patients ◽

Design Data ◽

Glucose Levels ◽

Blood Glucose Levels ◽

Average Blood Glucose ◽

Intensity Of Exercise

Diabetes Mellitus (DM) is a chronic disease with high prevalence, associated with various debilitating complications and can decreases the quality of life in people with it. It is important for people with DM to doing exercise to control the stability of their blood glucose levels. The purpose of this study was to finding out the association between frequency, duration, and intensity of exercise with average blood glucose levels in people with DM. This was an observational study that used case control design. Data obtained from interview with 20 samples from case group and 20 samples from control group, that had been chosen with systematic random sampling technique. Dependent variable of this study was the average blood glucose levels and independents variables were frequency, duration, intensity, and the kind of exercise. This study used Chi Square test 3 × 2 contingency tables to finding out the association and risk of dependent variable with independent variables,. The results showed that exercise factors that associated to average blood glucose levels were duration of exercise (p = 0.022) and intensity of exercise (p = 0.021). The frequency of exercise does not associated to average blood glucose levels (p = 0.340). Diabetic patients who did not do any exercise have the risk of having uncontrolled blood glucose levels. The conclusion was duration and intensity of exercise related significantly to blood glucose levels. By doing exercise three times a week for 30 minutes or more can decreases the risk of uncontrolled blood glucose levels in people with DM.Keywords: Diabetes mellitus, exercise, average blood glucose levels

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Mobile-based insulin dose adjustment for type 2 diabetes in community and rural populations: study protocol for a pilot randomized controlled trial

Therapeutic Advances in Endocrinology and Metabolism ◽

10.1177/2042018819836647 ◽

2019 ◽

Vol 10 ◽

pp. 204201881983664 ◽

Cited By ~ 2

Author(s):

Anish Menon ◽

Leonard Gray ◽

Farhad Fatehi ◽

Dominique Bird ◽

Darsy Darssan ◽

...

Keyword(s):

Blood Glucose ◽

Dose Adjustment ◽

Controlled Trial ◽

Insulin Dose ◽

Community Outreach ◽

Routine Care ◽

Glucose Levels ◽

Blood Glucose Levels ◽

Pilot Randomized Controlled Trial

Background: Insulin initiation and/or titration for type 2 diabetes (T2DM) is often delayed as it is a resource-intensive process, often requiring frequent exchange of information between a patient and their diabetes healthcare professional, such as a credentialed diabetes educator (CDE) for insulin dose adjustment (IDA). Existing models of IDA are unlikely to meet the increasing service demand unless efficiencies are increased. Mobile health (mHealth), a subset of Ehealth, has been shown to improve glycaemic control through enhanced self-management and feedback leading to improved patient satisfaction and could simultaneously reduce costs. Considering the potential benefits of mHealth, we have developed an innovative mHealth-based care model to support patients and clinicians in diabetes specialist community outreach and telehealth clinics, that is, REthinking Model of Outpatient Diabetes care utilizing EheaLth – Insulin Dose Adjustment (REMODEL-IDA). This model primarily aims to improve the glycaemic management of patients with T2DM on insulin, with the secondary aims of improving healthcare service delivery efficiency and the patients’ experience. Methods/Design: A two-arm pilot randomized controlled trial (RCT) will be conducted for 3 months with 44 participants, randomized at a 1:1 ratio to receive either the mHealth-based model of care (intervention) or routine care (control), in diabetes specialist community outreach and telehealth clinics. The intervention arm will exchange information related to blood glucose levels via the Mobile Diabetes Management System developed for outpatients with T2DM. They will receive advice on insulin titration from the CDE via the mobile-app and receive automated text-message prompts for better self-management based on their blood glucose levels and frequency of blood glucose testing. The routine care arm will be followed up via telephone calls by the CDE as per usual practice. The primary outcome is change in glycated haemoglobin, a marker of glycaemic management, at 3 months. Patient and healthcare provider satisfaction, and time required to perform IDA by healthcare providers in both arms will be collected. This pilot study will guide the conduct of a large-scale pragmatic RCT in regional Australia.

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A randomized, controlled trial of oral versus intravenous fluids for lowering blood glucose in emergency department patients with hyperglycemia

CJEM ◽

10.2310/8000.2013.131082 ◽

2014 ◽

Vol 16 (03) ◽

pp. 214-219 ◽

Cited By ~ 3

Author(s):

Sanjay Arora ◽

Marc A. Probst ◽

Laura Andrews ◽

Marissa Camilion ◽

Andrew Grock ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Blood Glucose ◽

Adverse Events ◽

Controlled Trial ◽

Fluid Administration ◽

Intravenous Fluids ◽

Glucose Levels ◽

Randomized Controlled ◽

Blood Glucose Levels ◽

The Mean

ABSTRACT Objectives: Blood glucose can be lowered via insulin and/or fluid administration. Insulin, although efficacious, can cause hypoglycemia and hypokalemia. Fluids do not cause hypoglycemia or hypokalemia, but the most effective route of fluid administration has not been well described. This study compared the efficacy and safety of oral versus intravenous fluids for reducing blood glucose in patients with hyperglycemia. Methods: We conducted a prospective, nonblinded, randomized, controlled trial. Inclusion criteria were blood glucose > 13.9 mmol/L, age > 18 years, and ability to tolerate oral fluids. Subjects were excluded for critical illness, contraindication to fluids, and/or hyperglycemia therapy prior to enrolment. Subjects were randomized to receive oral bottled water or intravenous normal saline (maximum 2 L) over 2 hours. The primary outcome of interest was a change in blood glucose at 2 hours across treatment arms. Results: The 48 subjects were randomized. Baseline blood glucose levels and total amount of fluid received were similar between the two groups. The mean decrease in blood glucose at 2 hours was similar for both treatment arms: a mean decrease of 3.4 mmol/L (20.2 mmol/L to 16.8 mmol/L) in the oral fluid group versus a mean decrease of 4.0 mmol/L (19.7 mmol/L to 15.7 mmol/L) in the intravenous fluid group. The mean difference between groups was −0.6 mmol/L (95% confidence interval −2.3–1.2; p = 0.51). No adverse events were observed in either group. Conclusion: In this unblinded randomized trial, oral and intravenous fluids were equally efficacious in lowering blood glucose levels in stable hyperglycemic patients and no adverse events were noted. Physicians should be mindful that, although similar, the reduction in blood glucose was modest in both groups.

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