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Clinical utility of 30-min plasma glucose for prediction of type 2 diabetes among people with prediabetes: Ancillary analysis of the diabetes community lifestyle improvement program.

ABSTRACT: AIMS:To examine the clinical utility of 30-min plasma glucose (30-min-PG) measurement during an oral glucose tolerance (OGTT) in predicting type 2 diabetes (T2DM). RESEARCH DESIGN AND METHODS:Data from a 3-year, randomized, controlled, primary prevention trial among 548 Asian Indians with prediabetes were analyzed. Participants underwent OGTT with PG measurements at fasting, 30-min, and 2-h at baseline and annually until the end of the study. Multivariable Cox regression models were constructed to calculate the risk of developing diabetes based on 30-min-PG levels. Improvement in prediction performance gained by adding an elevated level of 30-min-PG over prediabetic categories was calculated using the area-under-curve (AUC), net-reclassification (NRI), and integrated discrimination improvement (IDI) statistics. RESULTS:At the end of follow-up, 30.4% of individuals had been diagnosed with T2DM by ADA criteria. Based on the maximally selected log-rank statistics, the optimal 30-min-PG cut point for predicting incident T2DM was >182 mg/dl. Multivariable-adjusted Cox regression models showed an independent association between elevated 30-min-PG (>182 mg/dl) and incident diabetes (hazard ratio (95% CI): 1.85 [1.32, 2.59]; Dxy = 0.353, c-statistic = 0.676). The addition of an elevated 30-min-PG (>182 mg/dl) model significantly improved the prediction of diabetes (?deviance: -15.4; ?AUC: 0.11; NRIcontinuous: 0.51; IDI: 0.08) compared with IFG model alone) in individuals with prediabetes. CONCLUSION:In prediabetic individuals, baseline 30-min-PG independently predicted T2DM and significantly improved reclassification and discrimination. Therefore, 30-min-PG should be considered as part of the routine testing in addition to FPG and 2-h-PG for better risk stratification.

SUBMITTER: Jagannathan R

PROVIDER: S-EPMC7106975 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Clinical utility of 30-min plasma glucose for prediction of type 2 diabetes among people with prediabetes: Ancillary analysis of the diabetes community lifestyle improvement program.

Jagannathan Ram R Weber Mary Beth MB Anjana Ranjit M RM Ranjani Harish H Staimez Lisa R LR Ali Mohammed K MK Mohan Viswanathan V Narayan K M Venkat KMV

Diabetes research and clinical practice 20200211

<h4>Aims</h4>To examine the clinical utility of 30-min plasma glucose (30-min-PG) measurement during an oral glucose tolerance (OGTT) in predicting type 2 diabetes (T2DM).<h4>Research design and methods</h4>Data from a 3-year, randomized, controlled, primary prevention trial among 548 Asian Indians with prediabetes were analyzed. Participants underwent OGTT with PG measurements at fasting, 30-min, and 2-h at baseline and annually until the end of the study. Multivariable Cox regression models we ...[more]

PMID: 32057962

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Project description:BACKGROUND:The Centers for Disease Control and Prevention (CDC) diabetes prevention program (DPP) has formed the foundation for Type 2 Diabetes Mellitus (T2DM) prevention efforts and lifestyle change modifications in multiple care settings. To our knowledge, no randomized controlled trial has verified the efficacy of a fully mobile version of CDC's diabetes prevention program (DPP). OBJECTIVE:This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care. METHODS:Adults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP (Noom) or a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, how to interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A1c (HbA1c) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA1c levels. RESULTS:A total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In the intention-to-treat (ITT) analyses, changes in the participants' weight and BMI were significantly different at 6 months between the intervention and control groups, but there was no difference in HbA1c levels (mean difference 0.004%, SE 0.05; P=.94). Weight and BMI were lower in the intervention group by -2.64 kg (SE 0.71; P<.001) and -0.99 kg/m2 (SE 0.29; P=.001), respectively. These differences persisted at 12 months. However, in the analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; P<.001) at 6 months, maintaining 4.7% (SE 0.88; P<.001) of their weight loss at 12 months. The control group lost -0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA1c level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA1c levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA1c levels. CONCLUSIONS:This novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions. TRIAL REGISTRATION:ClinicalTrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342.

Project description:BackgroundMore than 88 million Americans are at risk of developing type 2 diabetes mellitus (T2DM). The National Diabetes Prevention Program's Lifestyle Change Program (DPP LCP) has been shown to be effective in reducing the risk of progressing from prediabetes to T2DM. However, most individuals who could benefit from the program do not enroll.ObjectiveThe aim of this trial is to test the real-world efficacy of 3 mobile phone-based approaches to increasing enrollment in the DPP LCP including a best-practice condition and 2 novel approaches.MethodsWe will conduct a 3-armed randomized clinical trial comparing enrollment and 1-month engagement in the DPP LCP among adults with prediabetes from 2 health care settings. Participants in the best-practice condition will receive SMS-based notifications that they have prediabetes and a link to a website that explains prediabetes, T2DM, and the DPP LCP. This will be followed by a single question survey, "Would you like the DPP LCP to call you to enroll?" Participants in the 2 intervention arms will receive the same best-practice intervention plus either 2 mobile 360° videos or up to 5 brief phone calls from a health coach trained in a motivational coaching approach known as Motivation and Problem Solving (MAPS). We will collect measures of diabetes-related knowledge, beliefs in the controllability of risk for T2DM, risk perceptions for T2DM, and self-efficacy for lifestyle change pre-intervention and 4 weeks later. The primary outcomes of the study are enrollment in the DPP LCP and 4-week engagement in the DPP LCP. In addition, data on the person-hours needed to deliver the interventions as well as participant feedback about the interventions and their acceptability will be collected. Our primary hypotheses are that the 2 novel interventions will lead to higher enrollment and engagement in the DPP LCP than the best-practice intervention. Secondary hypotheses concern the mechanisms of action of the 2 intervention arms: (1) whether changes in risk perception are associated with program enrollment among participants in the mobile 360° video group and (2) whether changes in self-efficacy for lifestyle change are associated with program enrollment among participants in the MAPS coaching group. Finally, exploratory analyses will examine the cost effectiveness and acceptability of the interventions.ResultsThe project was funded in September 2020; enrollment began in February 2021 and is expected to continue through July 2022.ConclusionsWe are conducting a test of 2 novel, scalable, mobile phone-based interventions to increase enrollment in the DPP LCP. If effective, they have tremendous potential to be scaled up to help prevent T2DM nationwide.Trial registrationClinicalTrials.gov NCT04746781; https://clinicaltrials.gov/ct2/show/NCT04746781.International registered report identifier (irrid)DERR1-10.2196/28884.

Project description:BackgroundSingapore'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.ObjectiveUsing 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.MethodsThis 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).ResultsA 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).ConclusionsAlthough 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.Trial registrationClinicalTrials.gov NCT03091517; https://clinicaltrials.gov/ct2/show/NCT03091517 (Archived by WebCite at http://www.webcitation.org/77rNqhwRn).

Project description:BackgroundFatty Liver Index (FLI) is strongly associated with changes in glycemic status and incident Type 2 Diabetes (T2D). The probability of reverting to normoglycemia from a state prediabetes could be determined by FLI, however such relationship remains poorly understood.AimTo determine the clinical interest of using FLI to estimate prediabetes reversion at 5 years in patients with impaired fasting plasma glucose at baseline, and identify those factors associated with changes in FLI, that could contribute to the reversion of prediabetes.MethodsThis 5-year cohort study included 16,648 Spanish working adults with prediabetes. Prediabetes was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dl according to the ADA criteria, while prediabetes reversion was defined as a FPG <100 mg/dL. The population was classified as: FLI <30 (no hepatic steatosis), FLI 30-59 (intermediate status), and FLI ≥60 (hepatic steatosis).ResultsAt 5 years follow-up, 33.7% of subjects reverted to normoglycemia (annual rate of 6.7%). The adjusted binomial logistic regression model showed that scoring FLI <30 (OR 1.544; 95% CI 1.355-1.759), performing at least 150 min/week of physical activity (OR 4.600; 95% CI 4.088-5.177) and consuming fruits and vegetables daily (OR 1.682; 95% CI 1.526-1.855) were associated with the probability of reverting form prediabetes to normoglycemia. The ROC curve for prediction of reversion showed that FLI (AUC 0.774;95% CI 0.767-0.781) was a better predictor than FPG (AUC 0.656; 95% CI 0.648-0.664).ConclusionsRegular physical activity, healthy dietary habits and absence of hepatic steatosis are independently associated with the probability of reversion to normoglycemia in adult workers with prediabetes at baseline. Low FLI values (especially FLI< 30) may be useful to predict the probability of prediabetes reversion, especially in active subjects with healthy eating habits, and thus identify those who might benefit from early lifestyle intervention.

Project description:BACKGROUND:People with prediabetes have an increased risk of developing type 2 diabetes (T2D). Few studies have evaluated the influence of lifestyle factors on the risk of progression to diabetes and reversion to normoglycemia. The aim of this study was to determine the incidence of T2D in a large cohort of workers with prediabetes, and to evaluate the influence of sociodemographic, clinical, metabolic, and lifestyle factors that affect the persistence of prediabetes and the progression to T2D. METHODS:A cohort study of 27,844 adult workers (aged 20 to 65 years) from Spain who had prediabetes based on an occupational medical examination from 2012 to 2013. Prediabetes was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL. At the baseline evaluation, sociodemographic, anthropometric, metabolic, and lifestyle data were collected. At the 5-year follow-up, incident T2D was defined as an FPG of at least 126 mg/dL or initiation of an antidiabetic medication. RESULTS:Among 235,995 initially screened workers, the prevalence of T2D was 14.19% (95% confidence interval (CI) 14.05 to 14.33) and the prevalence of prediabetes was 11.85% (95% CI 11.71 to 11.99). Follow-up data were available for 23,293 individuals with prediabetes. Among them, 36.08% (95% CI 35.46 to 36.70) returned to normoglycemia, 40.92% (95% CI 40.29 to 41.55) had persistent prediabetes, and 23.00% (95% CI 22.46 to 23.54) progressed to T2D. The risk for persistence of prediabetes and for progression to T2D increased with age, body mass index (BMI), triglyceride level, and less than 150 min/week of physical activity. An HbA1c level of 6% or greater was the strongest individual predictor of progression to T2D. CONCLUSIONS:Physical activity, diet, smoking, and BMI are modifiable factors that are associated with the persistence of prediabetes and the progression to T2D. The workplace is a feasible setting for the early detection of prediabetes and the promotion of lifestyles that can prevent progression to T2D.

Project description:BackgroundLifestyle interventions can delay the onset of type 2 diabetes in people with impaired glucose tolerance, but whether this leads subsequently to fewer complications or to increased longevity is uncertain. We aimed to assess the long-term effects of lifestyle interventions in people with impaired glucose tolerance on the incidence of diabetes, its complications, and mortality.MethodsThe original study was a cluster randomised trial, started in 1986, in which 33 clinics in Da Qing, China, were randomly assigned to either be a control clinic or provide one of three interventions (diet, exercise, or diet plus exercise) for 6 years for 577 adults with impaired glucose tolerance who usually receive their medical care from the clinics. Subsequently, participants were followed for up to 30 years to assess the effects of intervention on the incidence of diabetes, cardiovascular disease events, composite microvascular complications, cardiovascular disease death, all-cause mortality, and life expectancy.FindingsOf the 577 participants, 438 were assigned to an intervention group and 138 to the control group (one refused baseline examination). After 30 years of follow-up, 540 (94%) of 576 participants were assessed for outcomes (135 in the control group, 405 in the intervention group). During the 30-year follow-up, compared with control, the combined intervention group had a median delay in diabetes onset of 3·96 years (95% CI 1·25 to 6·67; p=0·0042), fewer cardiovascular disease events (hazard ratio 0·74, 95% CI 0·59-0·92; p=0·0060), a lower incidence of microvascular complications (0·65, 0·45-0·95; p=0·025), fewer cardiovascular disease deaths (0·67, 0·48-0·94; p=0·022), fewer all-cause deaths (0·74, 0·61-0·89; p=0·0015), and an average increase in life expectancy of 1·44 years (95% CI 0·20-2·68; p=0·023).InterpretationLifestyle intervention in people with impaired glucose tolerance delayed the onset of type 2 diabetes and reduced the incidence of cardiovascular events, microvascular complications, and cardiovascular and all-cause mortality, and increased life expectancy. These findings provide strong justification to continue to implement and expand the use of such interventions to curb the global epidemic of type 2 diabetes and its consequences.FundingUS Centers for Disease Control and Prevention, WHO, Chinese Center for Disease Control and Prevention, World Bank, Ministry of Public Health of the People's Republic of China, Da Qing First Hospital, China-Japan Friendship Hospital, and National Center for Cardiovascular Diseases & Fuwai Hospital.

Dataset Information

Clinical utility of 30-min plasma glucose for prediction of type 2 diabetes among people with prediabetes: Ancillary analysis of the diabetes community lifestyle improvement program.

Publications

Clinical utility of 30-min plasma glucose for prediction of type 2 diabetes among people with prediabetes: Ancillary analysis of the diabetes community lifestyle improvement program.

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