ResearchPad - psychosocial-research https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Can autonomy support have an effect on type 2 diabetes glycemic control? Results of a cluster randomized controlled trial]]> https://www.researchpad.co/article/N9c400ac6-5ee2-401e-b2aa-83d4cfaccd7a To assess whether social support or autonomy support intervention for patients with type 2 diabetes can achieve glycemic control at the end of intervention, and to test whether the glycemic control effect can be maintained for a long time.Research design and methodsIn this cluster randomized controlled trial, 18 community healthcare stations (CHSs) were randomized to the following: (1) usual care group (UCG) offering regular public health management services, (2) social support group (SSG) providing 3-month social support intervention based on problem solving principles, and (3) autonomy support group (ASG) offering 3-month autonomy support intervention based on self-determination theory. A total of 364 patients registered in the CHSs were enrolled into either of the three groups. The primary outcome was hemoglobin A1c (HbA1c), and secondary outcomes were diabetes self-management (DSM) behaviors. Assessment was conducted at baseline and at 3 and 6 months.ResultsPatients in ASG achieved better HbA1c reduction at the end of intervention (0.53% or 7.23 mmol/mol, p<0.001) than those in the UCG and successfully maintained it up to 6 months (0.42% or 5.41 mmol/mol, p<0.001). However, patients in SSG did not experience significant change in HbA1c at 3 or 6 months when compared with patients in UCG. Besides, patients in both the SSG (0.12, p<0.05) and ASG (0.22, p<0.001) experienced improvement in exercise at 3 months. Patients in ASG sustained improvement in exercise up to 6 months (0.21, p<0.001), but those in the SSG did not.ConclusionsAutonomy support for patients with type 2 diabetes could help achieve glycemic control at the end of intervention and successfully maintain it up to 6 months. These findings indicate that autonomy support has positive long-term effects on DSM behaviors and glycemic control and can be recommended in future diabetes intervention programs.Trial registration numberChiCTR1900024354. ]]> <![CDATA[Changes in Gut Microbiota–Related Metabolites and Long-term Successful Weight Loss in Response to Weight-Loss Diets: The POUNDS Lost Trial]]> https://www.researchpad.co/article/5c8eeb2dd5eed0c484ef9186

OBJECTIVE

Adiposity and the gut microbiota are both related to the risk of type 2 diabetes. We aimed to comprehensively examine how changes induced by a weight-loss diet intervention in gut microbiota–related metabolites, such as trimethylamine N-oxide (TMAO) and its precursors (choline and l-carnitine), were associated with improvements in adiposity and regional fat deposition.

RESEARCH DESIGN AND METHODS

This study included 510 overweight and obese individuals who were randomly assigned one of four diets varying in macronutrient intake. We examined associations of 6-month changes in blood metabolites (TMAO, choline, and l-carnitine) with improvements in body weight (BW), waist circumference (WC), body fat composition, fat distribution, and resting energy expenditure (REE).

RESULTS

Individuals with a greater reduction of choline (P < 0.0001) and l-carnitine (P < 0.01) rather than TMAO showed significant losses of BW and WC at 6 months. The reduction of choline was significantly predictive of decreases in body fat composition, fat distribution, and REE. Results of sensitivity analysis showed that the baseline diabetes risk status, such as the presence of hyperglycemia (31% of the total participants) and fasting glucose levels, did not modify the associations. Early changes in choline and l-carnitine were significantly predictive of weight loss over 2 years (P < 0.05 for all). Individuals with increases in choline or l-carnitine were 2.35-times (95% CI 1.38, 4.00) or 1.77-times (1.06, 2.95) more likely to fail to lose weight (–5% or more loss) at 2 years.

CONCLUSIONS

Overweight and obese individuals who showed decreases in circulating choline or l-carnitine levels achieved greater improvements of adiposity and energy metabolism by eating a low-calorie weight-loss diet, suggesting that such metabolites are predictive of individuals’ response to the treatment. Further investigations are necessary to confirm our findings, particularly in a population with prediabetes that is more representative of the U.S. population with obesity.

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<![CDATA[Psychometric testing of the Norwegian Diabetes Health Profile (DHP-18) in patients with type 1 diabetes]]> https://www.researchpad.co/article/5c3946d3d5eed0c484a392c1

Objective

The Diabetes Health Profile-18 (DHP-18) was developed to measure disease-specific health-related quality of life. It has been translated into Norwegian but remains invalidated. The purpose of this paper was to examine the psychometric properties of the Norwegian DHP-18.

Research design and methods

Participants with type 1 diabetes were recruited from three outpatient clinics in Norway. Clinical and sociodemographic data were collected, and participants completed the DHP-18 and the Short-Form 36 (SF-36). Descriptive analysis, frequencies, t-tests and the chi-squared tests were used. Principal axis factoring (PAF) and confirmatory factor analysis (CFA) were used. Convergent validity was tested using Spearman’s correlation between the DHP-18 and SF-36. Reliability was tested using Cronbach’s alpha and intraclass correlation coefficient.

Results

In total, 288 patients were included. No floor and ceiling effects were found. A forced PAF analysis revealed that three questions had an eigenvalue below 0.40. In the unforced PAF analysis, one question loaded below 0.40, while three questions loaded into a fourth factor. The correlation between the DHP-18 and SF-36 dimensions was low to moderate. Problematic internal consistency was observed for the disinhibited eating dimension in the forced PAF and in the suggested fourth dimension in the unforced PAF. CFA revealed poor fit. The test–retest reliability displayed good to excellent values, but responsiveness was limited.

Conclusions

Problematic issues were identified regarding factor structure, item loadings, internal consistency and responsiveness. Further evaluation of responsiveness is particularly recommended, and using a revised 14-item DHP version is suggested.

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<![CDATA[My Child Is Islet Autoantibody Positive: Impact on Parental Anxiety]]> https://www.researchpad.co/article/5c0d81e9d5eed0c484c06c02

OBJECTIVE

To assess parent anxiety in response to genetic and islet autoantibody (IA) testing in children at increased genetic risk for type 1 diabetes followed from birth in The Environmental Determinants of Diabetes in the Young (TEDDY) study.

RESEARCH DESIGN AND METHODS

Parent anxiety about TEDDY children’s risk was assessed with the State Anxiety Inventory (SAI). Parents completed the SAI when the child was 3, 6, and 15 months old and annually thereafter. Children were tested for IA every 3 months for 4 years and every 6 months thereafter. Parent SAI scores of 6,799 children followed with IA testing for at least 1 and up to 6 years were examined.

RESULTS

At study inception, parents showed high levels of anxiety in response to their child’s increased genetic type 1 diabetes risk; mothers were more anxious than fathers, and parents with diabetes in the family were more anxious than parents with no family history. In response to repeated IA-negative (IA−) test results, parent anxiety declined to normal levels. Anxiety increased in parents faced with an IA-positive (IA+) test result. Parents faced with two or more types of IA+ test results showed particularly high levels of anxiety (all P < 0.001).

CONCLUSIONS

Infant genetic screening for type 1 diabetes raises parent anxiety when the child is at increased risk, but anxiety dissipates over time in cases of repeated IA− results. IA+ results heighten parent anxiety, and parents faced with two or more types of IA+ results may experience considerable anxiety for longer periods.

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<![CDATA[Diabetes in a Large Dementia Cohort: Clinical Characteristics and Treatment From the Swedish Dementia Registry]]> https://www.researchpad.co/article/5c0d81eed5eed0c484c06cfe

OBJECTIVE

We aimed to investigate the differences in clinical characteristics and pharmacological treatment associated with the presence of diabetes in a large cohort of patients with dementia.

RESEARCH DESIGN AND METHODS

A cross-sectional registry-based study was conducted using data from the Swedish Dementia Registry (SveDem). Data on dementia diagnosis, dementia type, and demographic determinants were extracted from SveDem. Data from the Swedish Patient Register and Prescribed Drug Register were combined for the diagnosis of diabetes. Data on antidiabetic, dementia, cardiovascular, and psychotropic medications were extracted from the Swedish Prescribed Drug Register. Logistic regression was used to determine whether the variables were associated with diabetes after adjustment for confounders. In total, 29,630 patients were included in the study, and 4,881 (16.5%) of them received a diagnosis of diabetes.

RESULTS

In the fully adjusted model, diabetes was associated with lower age at dementia diagnosis (odds ratio [OR] 0.97 [99% CI 0.97–0.98]), male sex (1.41 [1.27–1.55]), vascular dementia (1.17 [1.01–1.36]), and mixed dementia (1.21 [1.06–1.39]). Dementia with Lewy bodies (0.64 [0.44–0.94]), Parkinson disease dementia (0.46 [0.28–0.75]), and treatment with antidepressants (0.85 [0.77–0.95]) were less common among patients with diabetes. Patients with diabetes who had Alzheimer disease obtained significantly less treatment with cholinesterase inhibitors (0.78 [0.63–0.95]) and memantine (0.68 [0.54–0.85]).

CONCLUSIONS

Patients with diabetes were younger at dementia diagnosis and obtained less dementia medication for Alzheimer disease, suggesting less optimal dementia treatment. Future research should evaluate survival and differences in metabolic profile in patients with diabetes and different dementia disorders.

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<![CDATA[Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release]]> https://www.researchpad.co/article/5c047f06d5eed0c48472915b

OBJECTIVE

To assess the ability of medication-assisted weight loss to prevent diabetes as a function of the baseline weighted Cardiometabolic Disease Staging (CMDS) score.

RESEARCH DESIGN AND METHODS

We pooled data from 3,040 overweight and obese participants in three randomized controlled trials—CONQUER, EQUIP, and SEQUEL—assessing efficacy and safety of phentermine/topiramate extended release (ER) for weight loss. In these double-blind phase III trials, overweight/obese adult patients were treated with a lifestyle intervention and randomly assigned to placebo versus once-daily oral phentermine/topiramate ER. The weighted CMDS score was calculated using baseline quantitative clinical data including waist circumference, blood glucose, blood pressure, and blood lipids. Incident diabetes was defined based on serial measures of fasting glucose, 2-h oral glucose tolerance test glucose, and/or HbA1c.

RESULTS

The absolute decrease in 1-year diabetes incidence rates in subjects treated with medication versus placebo was greatest in those with high-risk CMDS scores at baseline (10.43–6.29%), intermediate in those with moderate CMDS risk (4.67–2.37%), and small in the low-risk category (1.51–0.67%). The number of participants needed to treat to prevent one new case of diabetes over a 56-week period was 24, 43, and 120 in those with baseline CMDS scores of ≥60, 30–59, and 0–29, respectively.

CONCLUSIONS

Numbers needed to treat to prevent one case of type 2 diabetes are markedly lower in patients with high-risk scores. CMDS can be used to quantify risk of diabetes in overweight/obese individuals and predict the effectiveness of weight-loss therapy to prevent diabetes.

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<![CDATA[Strengths, Risk Factors, and Resilient Outcomes in Adolescents With Type 1 Diabetes: Results From Diabetes MILES Youth–Australia]]> https://www.researchpad.co/article/5c047f0bd5eed0c4847291d1

OBJECTIVE

Despite the challenges of living with type 1 diabetes, many adolescents achieve “resilient outcomes”: high engagement in self-management behaviors such as self-monitoring of blood glucose (SMBG), good quality of life (QOL), and within-target glycemic outcomes (HbA1c). Adaptive diabetes-related behaviors (i.e., “strengths”) are associated with resilient outcomes, yet the combination of risks and strengths in relation to resilient outcomes is unclear. The aim of this study was to investigate relations among diabetes strengths and resilient outcomes in the context of psychological and family risk factors.

RESEARCH DESIGN AND METHODS

A total of 471 Australian adolescents with type 1 diabetes (mean age 15.7 ± 1.9 years; diabetes duration 6.9 ± 4.2 years; 62% female; 53% using insulin pumps) completed a national cross-sectional survey about their diabetes-related strengths, risk factors (depressive/anxiety symptoms, family conflict), and resilient outcomes (SMBG frequency, general QOL, HbA1c).

RESULTS

Greater diabetes strengths were significantly related to resilient outcomes: more frequent SMBG (r = 0.39), lower HbA1c (r = −0.31), and higher general QOL (r = 0.50), as well as to lower risks: fewer depressive (r = −0.45) and anxiety (r = −0.40) symptoms and less conflict (r = 0.28). In multivariate regressions, diabetes strengths consistently related to all resilient outcomes beyond significant risk factors.

CONCLUSIONS

In a large sample of Australian adolescents, diabetes strengths were strongly related to key resilient outcomes, even in the presence of well-documented psychological and family risk factors. More research is needed to determine whether strengths reduce or buffer other risks. Given the associations with self-management, HbA1c, and general QOL, monitoring and enhancing diabetes strengths may support resilience promotion during a vulnerable developmental period.

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<![CDATA[Predicting and Reducing Driving Mishaps Among Drivers With Type 1 Diabetes]]> https://www.researchpad.co/article/5c01ba8ed5eed0c4841b7bd8

OBJECTIVE

Two aims of this study were to develop and validate A) a metric to identify drivers with type 1 diabetes at high risk of future driving mishaps and B) an online intervention to reduce mishaps among high-risk drivers.

RESEARCH DESIGN AND METHODS

To achieve aim A, in study 1, 371 drivers with type 1 diabetes from three U.S. regions completed a series of established questionnaires about diabetes and driving. They recorded their driving mishaps over the next 12 months. Questionnaire items that uniquely discriminated drivers who did and did not have subsequent driving mishaps were assembled into the Risk Assessment of Diabetic Drivers (RADD) scale. In study 2, 1,737 drivers with type 1 diabetes from all 50 states completed the RADD online. Among these, 118 low-risk (LR) and 372 high-risk (HR) drivers qualified for and consented to participate in a 2-month treatment period followed by 12 monthly recordings of driving mishaps. To address aim B, HR participants were randomized to receive either routine care (RC) or the online intervention “DiabetesDriving.com” (DD.com). Half of the DD.com participants received a motivational interview (MI) at the beginning and end of the treatment period to boost participation and efficacy. All of the LR participants were assigned to RC. In both studies, the primary outcome variable was driving mishaps.

RESULTS

Related to aim A, in study 1, the RADD demonstrated 61% sensitivity and 75% specificity. Participants in the upper third of the RADD distribution (HR), compared with those in the lower third (LR), reported 3.03 vs. 0.87 mishaps/driver/year, respectively (P < 0.001). In study 2, HR and LR participants receiving RC reported 4.3 and 1.6 mishaps/driver/year, respectively (P < 0.001). Related to aim B, in study 2, MIs did not enhance participation or efficacy, so the DD.com and DD.com + MI groups were combined. DD.com participants reported fewer hypoglycemia-related driving mishaps than HR participants receiving RC (P = 0.01), but more than LR participants receiving RC, reducing the difference between the HR and LR participants receiving RC by 63%. HR drivers differed from LR drivers at baseline across a variety of hypoglycemia and driving parameters.

CONCLUSIONS

The RADD identified higher-risk drivers, and identification seemed relatively stable across time, samples, and procedures. This 11-item questionnaire could inform patients at higher risk, and their clinicians, that they should take preventive steps to reduce driving mishaps, which was accomplished in aim B using DD.com.

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<![CDATA[Curcumin Extract for Prevention of Type 2 Diabetes]]> https://www.researchpad.co/article/5b9fbc7740307c778d1392e7

OBJECTIVE

To assess the efficacy of curcumin in delaying development of type 2 diabetes mellitus (T2DM) in the prediabetic population.

RESEARCH DESIGN AND METHODS

This randomized, double-blinded, placebo- controlled trial included subjects (n = 240) with criteria of prediabetes. All subjects were randomly assigned to receive either curcumin or placebo capsules for 9 months. To assess the T2DM progression after curcumin treatments and to determine the number of subjects progressing to T2DM, changes in β-cell functions (homeostasis model assessment [HOMA]-β, C-peptide, and proinsulin/insulin), insulin resistance (HOMA-IR), anti-inflammatory cytokine (adiponectin), and other parameters were monitored at the baseline and at 3-, 6-, and 9-month visits during the course of intervention.

RESULTS

After 9 months of treatment, 16.4% of subjects in the placebo group were diagnosed with T2DM, whereas none were diagnosed with T2DM in the curcumin-treated group. In addition, the curcumin-treated group showed a better overall function of β-cells, with higher HOMA-β (61.58 vs. 48.72; P < 0.01) and lower C-peptide (1.7 vs. 2.17; P < 0.05). The curcumin-treated group showed a lower level of HOMA-IR (3.22 vs. 4.04; P < 0.001) and higher adiponectin (22.46 vs. 18.45; P < 0.05) when compared with the placebo group.

CONCLUSIONS

A 9-month curcumin intervention in a prediabetic population significantly lowered the number of prediabetic individuals who eventually developed T2DM. In addition, the curcumin treatment appeared to improve overall function of β-cells, with very minor adverse effects. Therefore, this study demonstrated that the curcumin intervention in a prediabetic population may be beneficial.

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<![CDATA[Randomized Crossover Study to Examine the Necessity of an Injection-to-Meal Interval in Patients With Type 2 Diabetes and Human Insulin]]> https://www.researchpad.co/article/5ba4fee340307c6e82cb779f

OBJECTIVE

Patients with diabetes and insulin therapy with human insulin were usually instructed to use an interval of 20–30 min between the injection and meal. We examined the necessity of the injection-to-meal interval (IMI) in patients with type 2 diabetes mellitus (T2DM) and flexible insulin therapy with human insulin.

RESEARCH DESIGN AND METHODS

In this randomized, open crossover trial, 100 patients with T2DM (47% men, mean age = 66.7 years) were randomized to the IMI first group (phase 1, IMI 20 min; phase 2, no IMI) or IMI last group (phase 1, no IMI; phase 2, IMI 20 min). The main outcome measures were HbA1c, blood glucose profile, incidence of hypoglycemia, quality of life, treatment satisfaction, and patient preference.

RESULTS

Forty-nine patients were randomized to the IMI first group and 51 patients to the IMI last group. Omitting the IMI only slightly increases HbA1c (average intraindividual difference = 0.08% [95% CI 0.01–0.15]). Since the difference is not clinically relevant, a therapy without IMI is noninferior to its application (P < 0.001). In the secondary outcomes, the incidence of mild hypoglycemia also did not differ between no IMI and IMI significantly (mean of differences = −0.10, P = 0.493). No difference in the blood glucose profile of both groups was found. Treatment satisfaction increased markedly, by 8.08, if IMI was omitted (P < 0.001). The total score of the quality of life measure did not show differences between applying an IMI or not. Insulin therapy without IMI was preferred by 86.5% of patients (P < 0.001).

CONCLUSIONS

An IMI for patients with T2DM and preprandial insulin therapy is not necessary.

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<![CDATA[A Learner-Centered Diabetes Management Curriculum]]> https://www.researchpad.co/article/5b9fbc5a40307c778d1392d8

OBJECTIVE

Diabetes errors, particularly insulin administration errors, can lead to complications and death in the pediatric inpatient setting. Despite a lecture-format curriculum on diabetes management at our children’s hospital, resident diabetes-related errors persisted. We hypothesized that a multifaceted, learner-centered diabetes curriculum would help reduce pathway errors.

RESEARCH DESIGN AND METHODS

The 8-week curricular intervention consisted of 1) an online tutorial addressing residents’ baseline diabetes management knowledge, 2) an interactive diabetes pathway discussion, 3) a learner-initiated diabetes question and answer session, and 4) a case presentation featuring embedded pathway errors for residents to recognize, resolve, and prevent. Errors in the 9 months before the intervention, as identified through an incident reporting system, were compared with those in the 10 months afterward, with errors classified as relating to insulin, communication, intravenous fluids, nutrition, and discharge delay.

RESULTS

Before the curricular intervention, resident errors occurred in 28 patients (19.4% of 144 diabetes admissions) over 9 months. After the intervention, resident errors occurred in 11 patients (6.6% of 166 diabetes admissions) over 10 months, representing a statistically significant (P = 0.0007) decrease in patients with errors from before intervention to after intervention. Throughout the study, the errors were distributed into the categories as follows: insulin, 43.8%; communication, 39.6%; intravenous fluids, 14.6%; nutrition, 0%; and discharge delay, 2.1%.

CONCLUSIONS

An interactive learner-centered diabetes curriculum for pediatric residents can be effective in reducing inpatient diabetes errors in a tertiary children’s hospital. This educational model promoting proactive learning has implications for decreasing errors across other medical disciplines.

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<![CDATA[Efficacy of Metabolic and Psychological Screening for Mood Disorders Among Children With Type 1 Diabetes]]> https://www.researchpad.co/article/5b9fbc7e40307c778d1392eb

OBJECTIVE

To compare the diagnostic accuracy and time expenditure of screening models based on glycated hemoglobin (HbA1c) level and psychometric measures for mood disorder (MD) among children with type 1 diabetes.

RESEARCH DESIGN AND METHODS

With semistructured clinical interviews (Schedule for Affective Disorders and Schizophrenia for Children–Present and Lifetime version, 120 min/patient) as a reference for diagnosing MD, including major depressive disorder (MDD), we tested 163 subjects, aged 8 to 18 years, with type 1 diabetes. We evaluated four screening approaches: 1) Children’s Depression Inventory (CDI) at 30 min/patient, 2) HbA1c level, 3) HbA1c level plus CDI, and 4) HbA1c level plus Children's Depression Rating Scale (CDRS) at 40 min/patient. These tests were conducted with all participants, and the total time expenditure for all four approaches was calculated as the total time needed to implement successfully the screening for MD or MDD in the center.

RESULTS

HbA1c performed on par with individual psychometric tests in diagnosing MD or MDD. The HbA1c plus CDRS model was the best screening procedure for both MD and MDD, with diagnostic thresholds for HbA1c established at 8.7% and 9.0%, respectively. Cutoff points for CDRS assessed after filtering by HbA1c were 26 (MD) and 30 (MDD) points. Center-wide application of this procedure would result in an 83% reduction of the examination time necessary for the psychiatrist for MD screening and a 91% reduction for MDD screening, as compared with standard screening with CDI.

CONCLUSIONS

Use of HbA1c level followed by CDRS is a time-efficient procedure to screen for MD in children with type 1 diabetes.

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<![CDATA[Insulin Requirements in Type 1 Diabetic Pregnancy]]> https://www.researchpad.co/article/5b9523f540307c6d945defb4

OBJECTIVE

To evaluate the insulin requirements in women with type 1 diabetes during twin pregnancy compared with singleton pregnancy.

RESEARCH DESIGN AND METHODS

At 8, 14, 21, 27, and 33 gestational weeks, insulin requirements and HbA1c were compared between 15 twin pregnant women from 2000 to 2011 and 108 singleton pregnant women from 2004 to 2006.

RESULTS

In twin pregnancies, the weekly increase in daily insulin dose between 14 and 27 weeks was higher than in singleton pregnancies (median 3.0 international units [IU] [range 0.9–4.9] versus 1.5 IU [−1.5 to 5.9]; P = 0.008) and remained stable from 27 to 33 weeks. The increment in total insulin requirement from before pregnancy until 33 weeks tended to be higher in twin pregnancies (103% [36–257%] versus 71% [−20 to 276%]; P = 0.07). Throughout pregnancy, HbA1c was similar in twin and singleton pregnancies.

CONCLUSIONS

In twin pregnancies, the weekly increase in insulin dose between 14 and 27 weeks was doubled compared with singleton pregnancies.

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<![CDATA[Surgical Site Infections After Foot and Ankle Surgery]]> https://www.researchpad.co/article/5ac61983463d7e2c1af8ab08

OBJECTIVE

This prospective study was designed to evaluate the rate of surgical site infection (SSI) after foot and ankle surgery in patients with and without diabetes.

RESEARCH DESIGN AND METHODS

The study prospectively evaluated 1,465 consecutive foot and ankle surgical cases performed by a single surgeon.

RESULTS

The overall SSI rate in this study was 3.5%, with significantly more infections occurring in individuals with diabetes than in those without (9.5 vs. 2.4%, P < 0.001). Peripheral neuropathy, Charcot neuroarthropathy, current or past smoking, and increasing length of surgery were significantly associated with SSI on multivariate analysis.

CONCLUSIONS

This study demonstrates significant associations between the development of SSI and chronic complications of diabetes. We confirm previous findings that it is peripheral neuropathy and not diabetes itself that most strongly determines the development of postoperative infections in these surgical patients.

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<![CDATA[An Automated Internet Behavioral Weight-Loss Program by Physician Referral: A Randomized Controlled Trial]]> https://www.researchpad.co/article/5af6b7a3463d7e6b832ebbe4

OBJECTIVE

To evaluate 3- and 6-month weight-loss outcomes achieved when physicians refer overweight/obese patients to an automated 3-month Internet-based behavioral weight-loss intervention.

RESEARCH DESIGN AND METHODS

A total of 154 patients age 18–70 years with a BMI between 25 and 45 kg/m2 and access to a personal computer and the Internet were randomly assigned to 3 months of Internet behavioral intervention (IBI; n = 77) with 12 weekly videos teaching behavioral weight-loss skills, a platform for submitting self-monitored data, and automated feedback or an education-only Internet-delivered eating and activity control group (IDEA; n = 77). Outcome measures were weight loss after 3 months (primary outcome) and 6 months and changes in weight-control behaviors (secondary outcomes).

RESULTS

In intent-to-treat analyses with baseline weight carried forward for missing data, IBI produced significantly larger mean (SD) weight losses than IDEA at 3 months (5.5 kg [4.4] vs. 1.3 kg [2.1]) and 6 months (5.4 kg [5.6] vs. 1.3 kg [4.1]) (P < 0.001). Participants in IBI compared with IDEA were also more likely to achieve a clinically significant weight loss of 5% of initial body weight at 3 months (53.3 vs. 9.1%) and 6 months (48.1 vs. 15.6%) (P < 0.001) and reported more frequent use of weight control–related strategies.

CONCLUSIONS

Physician referral to an Internet-based behavioral weight-loss intervention produced clinically significant weight loss for over half of the patients studied. Further research is needed to determine the effectiveness of implementing this intervention more broadly within diverse health care settings.

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<![CDATA[Insulin Resistance and Inflammation in Hypogonadotropic Hypogonadism and Their Reduction After Testosterone Replacement in Men With Type 2 Diabetes]]> https://www.researchpad.co/article/5bd2ee12d5eed0c484f93581

OBJECTIVE

One-third of men with type 2 diabetes have hypogonadotropic hypogonadism (HH). We conducted a randomized placebo-controlled trial to evaluate the effect of testosterone replacement on insulin resistance in men with type 2 diabetes and HH.

RESEARCH DESIGN AND METHODS

A total of 94 men with type 2 diabetes were recruited into the study; 50 men were eugonadal, while 44 men had HH. Insulin sensitivity was calculated from the glucose infusion rate (GIR) during hyperinsulinemic-euglycemic clamp. Lean body mass and fat mass were measured by DEXA and MRI. Subcutaneous fat samples were taken to assess insulin signaling genes. Men with HH were randomized to receive intramuscular testosterone (250 mg) or placebo (1 mL saline) every 2 weeks for 24 weeks.

RESULTS

Men with HH had higher subcutaneous and visceral fat mass than eugonadal men. GIR was 36% lower in men with HH. GIR increased by 32% after 24 weeks of testosterone therapy but did not change after placebo (P = 0.03 for comparison). There was a decrease in subcutaneous fat mass (−3.3 kg) and increase in lean mass (3.4 kg) after testosterone treatment (P < 0.01) compared with placebo. Visceral and hepatic fat did not change. The expression of insulin signaling genes (IR-β, IRS-1, AKT-2, and GLUT4) in adipose tissue was significantly lower in men with HH and was upregulated after testosterone treatment. Testosterone treatment also caused a significant fall in circulating concentrations of free fatty acids, C-reactive protein, interleukin-1β, tumor necrosis factor-α, and leptin (P < 0.05 for all).

CONCLUSIONS

Testosterone treatment in men with type 2 diabetes and HH increases insulin sensitivity, increases lean mass, and decreases subcutaneous fat.

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<![CDATA[HbA1c After a Short Period of Monotherapy With Metformin Identifies Durable Glycemic Control Among Adolescents With Type 2 Diabetes]]> https://www.researchpad.co/article/5bd1ad6640307c7d3c921753

OBJECTIVE

To determine whether clinically accessible parameters early in the course of youth-onset type 2 diabetes predict likelihood of durable control on oral therapy.

RESEARCH DESIGN AND METHODS

TODAY was a randomized clinical trial of adolescents with type 2 diabetes. Two groups, including participants from all three treatments, were defined for analysis: 1) those who remained in glycemic control for at least 48 months of follow-up and 2) those who lost glycemic control before 48 months. Outcome group was analyzed in univariate and multivariate models as a function of baseline characteristics (age, sex, race/ethnicity, socioeconomic status, BMI, waist circumference, Tanner stage, disease duration, depressive symptoms) and biochemical measures (HbA1c, C-peptide, lean and fat body mass, insulin inverse, insulinogenic index). Receiver operating characteristic curves were used to analyze HbA1c cut points.

RESULTS

In multivariate models including factors significant in univariate analysis, only HbA1c and insulinogenic index at randomization remained significant (P < 0.0001 and P = 0.0002, respectively). An HbA1c cutoff of 6.3% (45 mmol/mol) (positive likelihood ratio [PLR] 3.7) was identified that optimally distinguished the groups; sex-specific cutoffs were 6.3% (45 mmol/mol) for females (PLR 4.4) and 5.6% (38 mmol/mol) for males (PLR 2.1).

CONCLUSIONS

Identifying youth with type 2 diabetes at risk for rapid loss of glycemic control would allow more targeted therapy. HbA1c is a clinically accessible measure to identify high risk for loss of glycemic control on oral therapy. Adolescents with type 2 diabetes unable to attain a non–diabetes range HbA1c on metformin are at increased risk for rapid loss of glycemic control.

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<![CDATA[LOGIC-Insulin Algorithm–Guided Versus Nurse-Directed Blood Glucose Control During Critical Illness]]> https://www.researchpad.co/article/5ad1e256463d7e1d54a195f6

OBJECTIVE

Tight blood glucose control (TGC) in critically ill patients is difficult and labor intensive, resulting in poor efficacy of glycemic control and increased hypoglycemia rate. The LOGIC-Insulin computerized algorithm has been developed to assist nurses in titrating insulin to maintain blood glucose levels at 80–110 mg/dL (normoglycemia) and to avoid severe hypoglycemia (<40 mg/dL). The objective was to validate clinically LOGIC-Insulin relative to TGC by experienced nurses.

RESEARCH DESIGN AND METHODS

The investigator-initiated LOGIC-1 study was a prospective, parallel-group, randomized, controlled clinical trial in a single tertiary referral center. A heterogeneous mix of 300 critically ill patients were randomized, by concealed computer allocation, to either nurse-directed glycemic control (Nurse-C) or algorithm-guided glycemic control (LOGIC-C). Glycemic penalty index (GPI), a measure that penalizes both hypoglycemic and hyperglycemic deviations from normoglycemia, was the efficacy outcome measure, and incidence of severe hypoglycemia (<40 mg/dL) was the safety outcome measure.

RESULTS

Baseline characteristics of 151 Nurse-C patients and 149 LOGIC-C patients and study times did not differ. The GPI decreased from 12.4 (interquartile range 8.2–18.5) in Nurse-C to 9.8 (6.0–14.5) in LOGIC-C (P < 0.0001). The proportion of study time in target range was 68.6 ± 16.7% for LOGIC-C patients versus 60.1 ± 18.8% for Nurse-C patients (P = 0.00016). The proportion of severe hypoglycemic events was decreased in the LOGIC-C group (Nurse-C 0.13%, LOGIC-C 0%; P = 0.015) but not when considered as a proportion of patients (Nurse-C 3.3%, LOGIC-C 0%; P = 0.060). Sampling interval was 2.2 ± 0.4 h in the LOGIC-C group versus 2.5 ± 0.5 h in the Nurse-C group (P < 0.0001).

CONCLUSIONS

Compared with expert nurses, LOGIC-Insulin improved efficacy of TGC without increasing rate of hypoglycemia.

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<![CDATA[Health Care Transition Preparation and Experiences in a U.S. National Sample of Young Adults With Type 1 Diabetes]]> https://www.researchpad.co/article/5bf90714d5eed0c4841c49cb

OBJECTIVE

Young adults with type 1 diabetes transitioning from pediatric to adult care are at risk for adverse outcomes. We developed a survey to evaluate transition experiences in two groups of young adults with type 1 diabetes, before (PEDS) and after (ADULT) transition to adult care.

RESEARCH DESIGN AND METHODS

We fielded an electronic survey to young adults (18 to <30 years) at 60 T1D Exchange Clinic Registry centers.

RESULTS

Surveys were completed by 602 young adults, 303 in the PEDS group (60% female, age 20 ± 2 years) and 299 in the ADULT group (62% female, age 24 ± 3 years). In the PEDS group, mean anticipated transition age was 22 ± 2 years; 64% remained in pediatric care because of emotional attachment to the provider. The ADULT group transitioned at age 19 ± 2 years, mainly after pediatric provider recommendation. More than 80% of respondents reported receiving counseling on type 1 diabetes self-management and screening tests from pediatric providers, but less than half (43% PEDS and 33% ADULT) reported discussing reproductive health. In the PEDS group, half had discussed transfer with pediatric providers. Of the ADULT participants, 63% received an adult provider referral, and 66% felt mostly/completely prepared to transition. ADULT participants with fewer pretransition pediatric visits or who felt unprepared for transition had increased odds of gaps >6 months between pediatric and adult care. Receipt of transition preparation counseling was not associated with self-reported hemoglobin A1c <7.0% in either group.

CONCLUSIONS

These results support the need for intensive efforts to integrate transition preparation counseling and care coordination into pediatric type 1 diabetes care.

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<![CDATA[Health Care Transition in Young Adults With Type 1 Diabetes: Perspectives of Adult Endocrinologists in the U.S.]]> https://www.researchpad.co/article/5bd6f6d5d5eed0c4847412c5

OBJECTIVE

Young adults with type 1 diabetes transitioning from pediatric to adult care are at risk for adverse outcomes. Our objective was to describe experiences, resources, and barriers reported by a national sample of adult endocrinologists receiving and caring for young adults with type 1 diabetes.

RESEARCH DESIGN AND METHODS

We fielded an electronic survey to adult endocrinologists with a valid e-mail address identified through the American Medical Association Physician Masterfile.

RESULTS

We received responses from 536 of 4,214 endocrinologists (response rate 13%); 418 surveys met the eligibility criteria. Respondents (57% male, 79% Caucasian) represented 47 states; 64% had been practicing >10 years and 42% worked at an academic center. Only 36% of respondents reported often/always reviewing pediatric records and 11% reported receiving summaries for transitioning young adults with type 1 diabetes, although >70% felt that these activities were important for patient care. While most respondents reported easy access to diabetes educators (94%) and dietitians (95%), fewer (42%) reported access to mental health professionals, especially in nonacademic settings. Controlling for practice setting and experience, endocrinologists without easy access to mental health professionals were more likely to report barriers to diabetes management for young adults with depression (odds ratio [OR] 5.3; 95% CI 3.4, 8.2), substance abuse (OR 3.5; 95% CI 2.2, 5.6), and eating disorders (OR 2.5; 95% CI 1.6, 3.8).

CONCLUSIONS

Our findings underscore the need for enhanced information transfer between pediatric and adult providers and increased mental health referral access for young adults with diabetes post-transition.

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