scholarly journals A Mobile Lifestyle Management Program (GlycoLeap) for People With Type 2 Diabetes: Single-Arm Feasibility Study (Preprint)

2018 ◽  
Author(s):  
David Koot ◽  
Paul Soo Chye Goh ◽  
Robyn Su May Lim ◽  
Yubing Tian ◽  
Teng Yan Yau ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Feasibility Study ◽  
User Satisfaction ◽  
Primary Outcome ◽  
Management Program ◽  
Secondary Outcome ◽  
Lifestyle Management ◽  
Program Engagement

BACKGROUND Singapore’s current prevalence of diabetes exceeds 13.6%. Although lifestyle modification can be effective for reducing the risks for complications of type 2 diabetes mellitus (T2DM), traditional lifestyle interventions are often difficult to administer in the primary care setting due to limited resources. Mobile health apps can address these limitations by offering low-cost, adaptable, and accessible platforms for disseminating lifestyle management interventions. OBJECTIVE Using the RE-AIM evaluation framework, this study assessed the potential effectiveness and feasibility of GlycoLeap, a mobile lifestyle management program for people with T2DM, as an add-on to standard care. METHODS This single-arm feasibility study recruited 100 patients with T2DM and glycated hemoglobin (HbA1c) levels of ≥7.5% from a single community health care facility in Singapore. All participants were given access to a 6-month mobile lifestyle management program, GlycoLeap, comprising online lessons and the Glyco mobile phone app with a health coaching feature. The GlycoLeap program was evaluated using 4 relevant dimensions of the RE-AIM framework: (1) reach (percentage who consented to participate out of all patients approached), (2) effectiveness (percentage point change in HbA1c [primary outcome] and weight loss [secondary outcome]), (3) implementation (program engagement as assessed by various participatory metrics), and (4) maintenance (postintervention user satisfaction surveys to predict the sustainability of GlycoLeap). Participants were assessed at baseline and at follow-up (≥12 weeks after starting the intervention). RESULTS A total of 785 patients were approached of whom 104 consented to participate, placing the reach at 13.2%. Four were excluded after eligibility screening, and 100 patients were recruited. Program engagement (implementation) started out high but decreased with time for all evaluated components. Self-reported survey data suggest that participants monitored their blood glucose on more days in the past week at follow-up compared to baseline (P<.001) and reported positive changes to their diet due to app engagement (P<.001) (implementation). Primary outcome data were available for 83 participants. Statistically significant improvements were observed for HbA1c (–1.3 percentage points, P<.001) with greater improvements for those who logged their weight more often (P=.007) (effectiveness). Participants also had a 2.3% reduction in baseline weight (P<.001) (effectiveness). User satisfaction was high with 74% (59/80) and 79% (63/80) of participants rating the app good or very good and claiming that they would probably or definitely recommend the app to others, respectively (maintenance). CONCLUSIONS Although measures of program engagement decreased with time, clinically significant improvements in HbA1c were achieved with the potential for broader implementation. However, we cannot rule out that these improvements were due to factors unrelated to GlycoLeap. Therefore, we would recommend evaluating the effectiveness and cost effectiveness of GlycoLeap using a randomized controlled trial of at least 12 months. CLINICALTRIAL ClinicalTrials.gov NCT03091517; https://clinicaltrials.gov/ct2/show/NCT03091517 (Archived by WebCite at http://www.webcitation.org/77rNqhwRn)

scholarly journals A Mobile Lifestyle Management Program (GlycoLeap) for People With Type 2 Diabetes: Single-Arm Feasibility Study

10.2196/12965 ◽  
2019 ◽  
Vol 7 (5) ◽  
pp. e12965 ◽  
Author(s):  
David Koot ◽  
Paul Soo Chye Goh ◽  
Robyn Su May Lim ◽  
Yubing Tian ◽  
Teng Yan Yau ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Feasibility Study ◽  
Management Program ◽  
Lifestyle Management

Abstract 018: Association of the Change in Physical Activity and Cardiovascular Disease Outcomes in the Look AHEAD Trial

Circulation ◽  
2018 ◽  
Vol 137 (suppl_1) ◽  
Author(s):  
John M Jakicic ◽  
Janet E Fulton ◽  
Wei Lang ◽  
Michael P Walkup
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Look Ahead ◽  
The Look ◽  
Fatal Myocardial Infarction

Introduction: The Look AHEAD trial examined cardiovascular disease incidence in adults with type 2 diabetes randomly assigned to an intensive lifestyle intervention compared to those randomly assigned to diabetes support and education (control). In a substudy, physical activity was assessed using accelerometry, which provides an opportunity to examine whether the incidence of cardiovascular disease varied by the measured change in physical activity. Hypothesis: There is a beneficial association between the 1- and 4-year change in physical activity and the pre-specified primary and secondary outcomes in participants in the Look AHEAD trial. Methods: Adults (N=1,978; 59.1±6.8 kg; 102.8±19.0 kg) with type 2 diabetes at 8 study sites, who completed physical activity was assessment using accelerometry for 1 week at 0, 1, and 4 years. MET-minutes per week of moderate-to-vigorous physical activity (MVPA) performed in bouts of at least 10 minutes was identified from the accelerometry data. The 1- and 4-year change in MVPA was computed as the difference from baseline. The primary outcome was pre-defined as non-fatal myocardial infarction, stroke, hospitalized angina, and cardiovascular disease death. The first secondary outcome was pre-defined as non-fatal myocardial infarction, stroke, hospitalized angina, CABG/PTCA, hospitalized congestive heart failure, carotid endarterectomy, peripheral vascular disease, and total mortality. The relationships between 1- and 4-year change in physical activity and the primary and secondary outcomes were examined using Cox proportional hazards models with data collapses across the two treatment groups. Hazard ratios (HR) were adjusted for age, sex, history of cardiovascular disease, duration of diabetes, diabetes medication use, baseline weight, change in weight, and baseline physical activity. Results: MVPA [Median (25 th , 75 th percentile)] was 167.6 (0,545.5), 205.4 (0, 700.2), and 91.3 (0, 418.9) MET-minutes per week at 0, 1 and 4 years, respectively. Change in MVPA at 1-year was not significantly associated with the primary outcome [HR per 100 MET-minutes per week = 1.001 (95% CI: 0.985, 1.017)] or secondary outcome [HR per 100 MET-minutes per week = 0.989 (95% CI: 0.966, 1.013)] assessed across 8.8±2.4 years of follow-up. Change in MVPA at 4-years was significantly associated with a reduction in the primary [HR per 100 MET-minutes per week = 0.949 (95% CI: 0.912, 0.987)] and the secondary outcome [HR per 100 MET-minutes per week = 0.897 (95% CI: 0.843, 0.954)] assessed across 9.2±1.8 years of follow-up. Conclusions: Change in physical activity at 4-years is associated with a reduction in incidence of cardiovascular disease in adults with type 2 diabetes. These findings suggest improvements in physical activity may need to be sustained for a relatively long period (4 years) to elicit a beneficial effect on incidence of cardiovascular disease.

Improved Glycemic Control With a Digital Health Intervention in Adults With Type 2 Diabetes: Retrospective Study (Preprint)

2021 ◽  
Author(s):  
Gretchen Zimmermann ◽  
Aarathi Venkatesan ◽  
Kelly Rawlings ◽  
Michael Scahill
Keyword(s):  
Type 2 Diabetes ◽  
Glycemic Control ◽  
Diabetes Management ◽  
Digital Health ◽  
Management Program ◽  
Health Intervention ◽  
Diabetes Management Program ◽  
Program Engagement

BACKGROUND Traditional lifestyle interventions have shown limited success in improving diabetes related outcomes. Digital interventions with continuously available support and personalized educational content may offer unique advantages for self-management and glycemic control. OBJECTIVE In the present study, we evaluate changes in glycemic control among participants with type 2 diabetes who enrolled in a digital diabetes management program. METHODS The study employed a single-arm, retrospective design. A total of 950 participants with a HbA1c baseline value of at least 7.0% enrolled in the Vida Health Diabetes Management Program. The intervention included one-to-one remote sessions with a Vida provider and structured lessons and tools related to diabetes management. Hemoglobin A1c (HbA1c) was the primary outcome measure. A total of 258 (27.2%) participants had a follow-up HbA1c completed at least 90 days from program start. Paired t-tests were utilized to evaluate changes in HbA1c between baseline and follow-up. Additionally, a cluster-robust multiple regression analysis was employed to evaluate the relationship between high and low program engagement and HbA1c change. A repeated measures ANOVA was used to evaluate difference in HbA1c as a function of measurement period (ie, pre-Vida enrollment, baseline, and post-enrollment follow-up). RESULTS We observed a significant reduction in HbA1c of -0.81 points between baseline (M = 8.68, SD = 1.7) and follow-up (M = 7.88, SD = 1.46), t(257) = 7.71, P = .00). Among participants considered high-risk (baseline HbA1c >= 8), there was an average reduction of -1.44 points between baseline (M = 9.73, SD = 1.68) and follow-up (M = 8.29, SD = 1.64), t(139) = 9.14, P = .00). Additionally, average follow-up HbA1c (M = 7.82, SD = 1.41) was significantly lower than pre-enrollment HbA1c (M = 8.12, SD = 1.46), F(2, 210) = 22.90, P = .00. There was also significant effect of engagement on HbA1c change, β = -.60, P = .00, such that high engagement was associated with a greater decrease in HbA1c (M = -1.02, SD = 1.60) compared to low-engagement, (M = -.61, SD = 1.72). CONCLUSIONS The present study revealed clinically meaningful improvements in glycemic control among participants enrolled in a digital diabetes management intervention. Higher program engagement was associated with greater improvements in HbA1c. The findings of the present study suggest that digital health intervention may represent an accessible, scalable, and effective solution to diabetes management and improved HbA1c. The study was limited by a non-randomized, observational design and limited post-enrollment follow-up data.

scholarly journals Behavioural interventions to promote physical activity in a multiethnic population at high risk of diabetes: PROPELS three-arm RCT

2021 ◽  
Vol 25 (77) ◽  
pp. 1-190
Author(s):  
Kamlesh Khunti ◽  
Simon Griffin ◽  
Alan Brennan ◽  
Helen Dallosso ◽  
Melanie Davies ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Confidence Interval ◽  
Primary Outcome ◽  
Health Technology ◽  
Accelerometer Data ◽  
Ambulatory Activity ◽  
Steps Per Day

Background Type 2 diabetes is a leading cause of mortality globally and accounts for significant health resource expenditure. Increased physical activity can reduce the risk of diabetes. However, the longer-term clinical effectiveness and cost-effectiveness of physical activity interventions in those at high risk of type 2 diabetes is unknown. Objectives To investigate whether or not Walking Away from Diabetes (Walking Away) – a low-resource, 3-hour group-based behavioural intervention designed to promote physical activity through pedometer use in those with prediabetes – leads to sustained increases in physical activity when delivered with and without an integrated mobile health intervention compared with control. Design Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with follow-up conducted at 12 and 48 months. Setting Primary care and the community. Participants Adults whose primary care record included a prediabetic blood glucose measurement recorded within the past 5 years [HbA1c ≥ 42 mmol/mol (6.0%), < 48 mmol/mol (6.5%) mmol/mol; fasting glucose ≥ 5.5 mmol/l, < 7.0 mmol/l; or 2-hour post-challenge glucose ≥ 7.8 mmol/l, < 11.1 mmol/l] were recruited between December 2013 and February 2015. Data collection was completed in July 2019. Interventions Participants were randomised (1 : 1 : 1) using a web-based tool to (1) control (information leaflet), (2) Walking Away with annual group-based support or (3) Walking Away Plus (comprising Walking Away, annual group-based support and a mobile health intervention that provided automated, individually tailored text messages to prompt pedometer use and goal-setting and provide feedback, in addition to biannual telephone calls). Participants and data collectors were not blinded; however, the staff who processed the accelerometer data were blinded to allocation. Main outcome measures The primary outcome was accelerometer-measured ambulatory activity (steps per day) at 48 months. Other objective and self-reported measures of physical activity were also assessed. Results A total of 1366 individuals were randomised (median age 61 years, median body mass index 28.4 kg/m2, median ambulatory activity 6638 steps per day, women 49%, black and minority ethnicity 28%). Accelerometer data were available for 1017 (74%) and 993 (73%) individuals at 12 and 48 months, respectively. The primary outcome assessment at 48 months found no differences in ambulatory activity compared with control in either group (Walking Away Plus: 121 steps per day, 97.5% confidence interval –290 to 532 steps per day; Walking Away: 91 steps per day, 97.5% confidence interval –282 to 463). This was consistent across ethnic groups. At the intermediate 12-month assessment, the Walking Away Plus group had increased their ambulatory activity by 547 (97.5% confidence interval 211 to 882) steps per day compared with control and were 1.61 (97.5% confidence interval 1.05 to 2.45) times more likely to achieve 150 minutes per week of objectively assessed unbouted moderate to vigorous physical activity. In the Walking Away group, there were no differences compared with control at 12 months. Secondary anthropometric, biomechanical and mental health outcomes were unaltered in either intervention study arm compared with control at 12 or 48 months, with the exception of small, but sustained, reductions in body weight in the Walking Away study arm (≈ 1 kg) at the 12- and 48-month follow-ups. Lifetime cost-effectiveness modelling suggested that usual care had the highest probability of being cost-effective at a threshold of £20,000 per quality-adjusted life-year. Of 50 serious adverse events, only one (myocardial infarction) was deemed possibly related to the intervention and led to the withdrawal of the participant from the study. Limitations Loss to follow-up, although the results were unaltered when missing data were replaced using multiple imputation. Conclusions Combining a physical activity intervention with text messaging and telephone support resulted in modest, but clinically meaningful, changes in physical activity at 12 months, but the changes were not sustained at 48 months. Future work Future research is needed to investigate which intervention types, components and features can help to maintain physical activity behaviour change over the longer term. Trial registration Current Controlled Trials ISRCTN83465245. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 77. See the NIHR Journals Library website for further project information.

scholarly journals Assessment of a Clinical Case for A Female Patient with Type 2 Diabetes Using the 2021 Consensus Report on Type 2 Diabetes Remission Discussions Sponsored by American Diabetes Association Based on GH-Method: math-physical medicine (No. 506)

2021 ◽  
Vol 6 (6) ◽  
Keyword(s):  
Type 2 Diabetes ◽  
Female Patient ◽  
Hba1c Level ◽  
Clinical Case ◽  
American Diabetes Association ◽  
Management Program ◽  
Lifestyle Management ◽  
One Year ◽  
Consensus Report

This 73-year-old female patient has suffered from type 2 diabetes (T2D), hypertension, and hyperlipidemua for over 20 years. She started taking Metformin in 1999 and ceased taking it on 1/7/2019. As of 4/3/2019, her HbA1C level was at 6.6%. Since 4/4/2019, she implemented a lifestyle management program which not only focuses on diet and exercise but also factors in sleep, stress, life routines and habits, as well as environmental factors. In this article, the author applies the final conclusions from the American Diabetes Association (ADA) 2021 consensus report regarding “T2D Remission”. For this clinical case, he analyzes the patient’s present conditions to determine if she satisfies the criteria of “T2D remission” or not. The defined criteria of “remission” include timespan of at least one year, HbA1C level less than 6.5%, fasting plasma glucose (FPG) level less than 126 mg/dL, and estimated HbA1C (eA1C) values based on the mean continuous glucose monitoring (CGM) glucose data less than 6.5%. In conclusion, according to the ADA 2021 consensus report, this female patient is in “remission” for T2D. In summary, over the past year from 9/5/2020 to 9/5/2021, her average lab-A1C is 6.3%, mean CGM FPG value is 102 mg/dL, and CGM eAG is 5.7%. First, the selected one year satisfies the timespan requirement cited in the 2021 consensus report. Her set of glucose data has been collected over ~3 years, after post-Metformin (started on 1/7/2019) and her initiation of lifestyle management program that began on 4/4/2019. Second, all of her A1C values, both lab-tested and CGM eA1C, are less than 6.5% and her mean CGM FPG level is less than 126 mg/dL. Finally, she keeps a regular routine with quarterly medical examinations to monitor various diabetes complications, including macrovascular, micro- vascular, neural, and hormonal systems. The author understands and agrees with the consensus report that diabetes is non-curable and at most is “controllable” or “partially reversible”. Nevertheless, this female patient has also adopted a similar lifestyle improvement program as the author in order to deal with the root causes of her multiple metabolic disorders, particularly T2D, instead of suppressing the external symptoms of diabetes through medication intervention.

scholarly journals Prognostic Value of Secreted Frizzled-Related Protein 5 in Heart Failure Patients With and Without Type 2 Diabetes Mellitus

2020 ◽  
Vol 13 (9) ◽  
Author(s):  
Jiandi Wu ◽  
Haoxiao Zheng ◽  
Xinyue Liu ◽  
Peisong Chen ◽  
Yunlong Zhang ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Risk Factors ◽  
Heart Failure ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Prognostic Value ◽  
Primary Outcome ◽  
Related Protein

Background: Patients with heart failure (HF) with diabetes mellitus have distinct biomarker profiles compared with those without diabetes mellitus. SFRP5 (secreted frizzled-related protein 5) is an anti-inflammatory adipokine with an important suppressing role on the development of type 2 diabetes mellitus (T2DM). This study aimed to evaluate the prognostic value of SFRP5 in patients with HF with and without T2DM. Methods: The study included 833 consecutive patients with HF, 312 (37.5%) of whom had T2DM. Blood samples were collected at presentation, and SFRP5 levels were measured. The primary outcome was the composite end points of first occurrence of HF rehospitalization or all-cause mortality during follow-up. Results: During median follow-up of 2.1 years, 335 (40.2%) patients in the cohort experienced the composite primary outcome. After adjustment for multiple risk factors, each doubling of SFRP5 level was associated with a 21% decreased risk of primary outcomes in the overall study population ( P <0.001). Subgroup analyses showed that the association between level of SFPR5 and primary outcomes may be stronger in patients with T2DM (hazard ratio, 0.69 [95% CI, 0.61–0.79]) than in patients without T2DM (hazard ratio, 0.89 [95% CI, 0.79–1.01]; interaction P =0.006). Similar associations were observed when taking SFRP5 as a categorical variable. Addition of SFRP5 significantly improved discrimination and reclassification of the incident primary outcomes beyond clinical risk factors and N-terminal pro-B-type natriuretic peptide in all patients with HF and those with T2DM (all P <0.01). Conclusions: SFRP5 is an independent novel biomarker for risk stratification in HF, especially in HF with T2DM.

scholarly journals The effect of menaquinone-7 supplementation on vascular calcification in patients with diabetes: a randomized, double-blind, placebo-controlled trial

2019 ◽  
Vol 110 (4) ◽  
pp. 883-890 ◽  
Author(s):  
S R Zwakenberg ◽  
P A de Jong ◽  
J W Bartstra ◽  
R van Asperen ◽  
J Westerink ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Vascular Calcification ◽  
Vitamin K ◽  
Controlled Trial ◽  
Matrix Gla Protein ◽  
Arterial Calcification ◽  
Secondary Outcome ◽  
Double Blind

ABSTRACT Background Vitamin K occurs in the diet as phylloquinone and menaquinones. Observational studies have shown that both phylloquinone and menaquinone intake might reduce cardiovascular disease (CVD) risk. However, the effect of vitamin K on vascular calcification is unknown. Objectives The aim of this study was to assess if menaquinone supplementation, compared to placebo, decreases vascular calcification in people with type 2 diabetes and known CVD. Methods In this double-blind, randomized, placebo-controlled trial, we randomly assigned men and women with type 2 diabetes and CVD to 360 µg/d menaquinone-7 (MK-7) or placebo for 6 mo. Femoral arterial calcification at baseline and 6 mo was measured with 18sodium fluoride positron emission tomography (18F-NaF PET) scans as target-to-background ratios (TBRs), a promising technique to detect active calcification. Calcification mass on conventional computed tomography (CT) scan was measured as secondary outcome. Dephosphorylated–uncarboxylated matrix Gla protein (dp-ucMGP) concentrations were measured to assess compliance. Linear regression analyses were performed with either TBR or CT calcification at follow-up as the dependent variable, and treatment and baseline TBR or CT calcification as independent variables. Results We randomly assigned 35 patients to the MK-7 group (33 completed follow-up) and 33 to the placebo group (27 completed follow-up). After the 6-mo intervention, TBR tended to increase in the MK-7 group compared with placebo (0.25; 95% CI: −0.02, 0.51; P = 0.06), although this was not significant. Log-transformed CT calcification mass did not increase in the intervention group compared with placebo (0.50; 95% CI: −0.23, 1.36; P = 0.18). MK-7 supplementation significantly reduced dp-ucMGP compared with placebo (−205.6 pmol/L; 95% CI: −255.8, −155.3 pmol/L). No adverse events were reported. Conclusion MK-7 supplementation tended to increase active calcification measured with 18F-NaF PET activity compared with placebo, but no effect was found on conventional CT. Additional research investigating the interpretation of 18F-NaF PET activity is necessary. This trial was registered at clinicaltrials.gov as NCT02839044.

scholarly journals Muscle strength, an independent determinant of glycemic control in older adults with long-standing type 2 diabetes: a prospective cohort study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Bo Kyung Koo ◽  
Seoil Moon ◽  
Min Kyong Moon
Keyword(s):  
Insulin Resistance ◽  
Type 2 Diabetes ◽  
Older Adults ◽  
Glycemic Control ◽  
Muscle Mass ◽  
Older Patients ◽  
Primary Outcome ◽  
Muscle Quality

Abstract Background Although the proportion of older patients with type 2 diabetes mellitus (T2DM) has increased, few studies have reported the factors affecting glucose levels in older patients with long-standing T2DM. This study assessed the determinants of glycemic control in older adults with T2DM of a duration of ≥10 years, including muscle mass, muscle quality, and β-cell function. Methods This was a prospective study of older patients aged ≥60 years with a T2DM duration of ≥10 years. The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index, handgrip strength (HGS), and body composition through bioelectrical impedance analysis were assessed. The primary outcome was a composite of: (i) increment of glycated hemoglobin (HbA1c) from the baseline ≥0.6% and (ii) HbA1c ≥ 9% at any time point during the follow-up period. To find the predicting determinants of the outcome, we performed the Cox proportional hazard analysis. Results Among 100 patients (mean age, 64.0 ± 8.6 years; median duration of diabetes, 20 [interquartile range (IQR), 17–23] years; median HbA1c at baseline, 7.1 [IQR, 6.7–7.4] %), the primary outcome was observed in 40 (40.0%) patients during 4.0 (IQR 2.3–5.0) years of follow-up. A Cox proportional hazards model adjusted for age, sex, baseline HbA1c, obesity, duration of DM and anti-diabetic medication at baseline showed that low HGS and insulin resistance at the baseline were independent determinants of the primary outcome (hazard ratio [HR] = 2.23 [95% confidence interval (CI), 1.06–4.72] and 2.39 [95% CI, 1.18–4.83], respectively). Sex stratification confirmed that HGS and muscle mass were independent determinants of the primary outcome only in women (HR per quartile, 0.58 [95% CI, 0.37–0.93] and 0.46 [95% CI, 0.25–0.85], respectively). `. Conclusions Low HGS and insulin resistance were independent risk factors for aggravated glycemic control among older patients with long standing T2DM.

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