scholarly journals Incorporating Post-Cessation Weight-Control Coaching into Smoking Cessation Therapy to Reduce Type 2 Diabetes Risk

Nutrients ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 3360
Author(s):  
Chien-Hsieh Chiang ◽  
Yi-Han Sheu ◽  
Fei-Ran Guo ◽  
Wan-Wan Lin ◽  
Guan-Ru Chen ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Smoking Cessation ◽  
Usual Care ◽  
Weight Control ◽  
Controlled Trial ◽  
Intention To Treat ◽  
Smoking Cessation Therapy

Post-cessation weight gain (PCWG) facilitates short-term type 2 diabetes (T2D) risk in prediabetic smokers in the absence of complementary measures. In this shared decision-making-based non-randomized controlled trial, prediabetic smokers joined the Fight Tobacco and Stay Fit (FIT2) program or received usual care. The 16-week FIT2 program combined smoking cessation therapy with individualized coaching in diet and physical activity strategies for PCWG restriction (NCT01926041 at ClinicalTrials.gov). During a mean follow-up period of 1316 days, 217 participants (36.8%) developed T2D, and 68 (11.5%) regressed to normoglycemia. In the intention-to-treat analysis (n = 589), the FIT2 program was associated with a reduced T2D risk (HR, 0.58; 95% CI, 0.40–0.84) and a higher probability of regression to normoglycemia (HR, 1.91; 95% CI, 1.04–3.53) compared with usual care. The post-program quitters were at lower T2D risk (HR, 0.63; 95% CI, 0.44–0.92) and were more likely to regress to normoglycemia (HR, 1.83; 95% CI, 1.01–3.30) compared with the controls in the time-varying analysis (n = 532). We demonstrated that the FIT2 program was negatively associated with long-term T2D risk and positively associated with the probability of regression to normoglycemia compared with usual care. To prevent T2D development, we recommend simultaneously promoting smoking abstinence and lifestyle coaching for PCWG restriction.

scholarly journals Risk of lower extremity amputations in patients with type 2 diabetes using sodium-glucose co-transporter 2 inhibitors

2021 ◽  
Author(s):  
Spela Zerovnik ◽  
Mitja Kos ◽  
Igor Locatelli
Keyword(s):  
Type 2 Diabetes ◽  
Lower Extremity ◽  
Study Cohort ◽  
Dipeptidyl Peptidase 4 ◽  
Intention To Treat ◽  
Dipeptidyl Peptidase 4 Inhibitors ◽  
History Of

Abstract Aims To compare the influence of sodium-glucose co-transporter 2 inhibitors (SGLT2i) and dipeptidyl peptidase-4 inhibitors (DPP-4i) on the risk of lower extremity amputations in patients with type 2 diabetes in Slovenia. Methods This retrospective cohort study included patients aged 40 years or more who were administered a newly introduced SGLT2i or DPP-4i between June 2014 and June 2018. Patients treated with insulin at baseline and patients with a history of amputation were excluded. Patients were matched in a 1:1 ratio using propensity score matching. Survival analysis was performed; hazard ratio (HR) and ratios of cumulative hazards at 1, 2, 3, and 4 years were estimated. On-treatment and intention-to-treat approaches were used. Results The study cohort (mean age: 64 years) consisted of 2,939 new users of SGLT2i (empagliflozin, 59%; dapagliflozin, 41%) matched to 2,939 new users of DPP-4i. In the on-treatment analysis (median follow-up of 2 years), the incidence of amputations was higher in SGLT2i than in DPP-4i users (4.2 vs. 2.7 per 1,000 patient years), resulting in a HR of 1.58 (95% CI 0.85–2.92; p = 0.145). An intention-to-treat analysis yielded to similar HR of 1.86 (95% CI: 1.10–3.14; p = 0.020). There was no difference in amputation rates in the first two years, but SGLT2i users had a 2.81-fold higher (95% CI: 1.63–4.84; p = 0.007) cumulative hazard of amputation at 4 years than did DPP-4i users. Conclusions Compared with DPP-4i use, SGLT2i use did not result in a statistically significant higher overall risk of lower extremity amputations. However, the results suggest that SGLT2i may increase the risk of amputation with long-term use.

scholarly journals Immediate and Long-Term Effects of an 8-Week Digital Mental Health Intervention on Adults With Poorly Managed Type 2 Diabetes: Protocol for a Randomized Controlled Trial

10.2196/18578 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e18578
Author(s):  
Eliane Boucher ◽  
Judith T Moskowitz ◽  
Gina M Kackloudis ◽  
Julia L Stafford ◽  
Ian Kwok ◽  
...  
Keyword(s):  
Mental Health ◽  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Long Term Effects ◽  
Randomized Controlled ◽  
Short And Long Term ◽  
Therapeutic Platform

Background Diabetes is a leading cause of years of life lost and accounts for approximately one-fourth of health care dollars spent in the United States. Many of these costs are related to poor medication adherence and lack of self-care behaviors and are thus preventable. Depression, which is more prevalent among people with diabetes than in the general population, predicts poorer management of one’s diabetes, whereas positive affect predicts engaging in more positive health behaviors. Consequently, interventions that improve depression and positive affect may also improve diabetes-related outcomes among people with diabetes. Although preliminary research on the impact of such interventions among people with diabetes is promising, these studies focused primarily on in-person interventions, have had small samples, and lack long-term follow-up. Objective This study aims to examine the short- and long-term effects of a digital therapeutic platform focused on mental health among adults with poorly managed type 2 diabetes and elevated levels of depression. Methods This is a randomized controlled trial in which adults with a type 2 diabetes diagnosis, elevated hemoglobin A1c (HbA1c) levels (≧7), and moderate to severe depressive symptoms will be randomly assigned to a positive emotion regulation skills intervention group or a sham digital intervention with only psychoeducational content. The study will take place over 14 months, including the 8-week intervention (or control) delivered via a digital therapeutic platform (Happify Health) and follow-up assessments at 3, 6, and 12 months postintervention. Throughout the intervention and for 1 week at each postintervention follow-up, participants will complete daily assessments of diabetes-related distress, diabetes regimen adherence, and mood. Our primary outcome, HbA1c, will be self-reported every 3 months throughout the study. Secondary and exploratory outcomes will be assessed at baseline; at 8 weeks; and at 3, 6, and 12 months postintervention. Results Recruitment is expected to begin in June 2020. Participants will begin the study as they are recruited and will finish in waves. The final wave of data collection from the 8-week intervention is expected for winter 2020, with the completion of the 12-month follow-up in winter 2021. Conclusions Although previous research suggests that in-person psychological interventions have promising effects on both psychological and physical outcomes among adults with diabetes, digital interventions can be advantageous because they are easily scalable and reduce many barriers that prevent people from seeking treatment. This trial will provide important information about the effects of a digital mental health intervention among adults with type 2 diabetes, assessing both short- and long-term effects of this intervention on HbA1c, depressive symptoms, and other diabetes-specific outcomes. If successful, this may introduce a scalable intervention that would help reduce some of the preventable costs associated with diabetes. Trial Registration ClinicalTrials.gov NCT04068805; https://clinicaltrials.gov/ct2/show/NCT04068805. International Registered Report Identifier (IRRID) PRR1-10.2196/18578

scholarly journals Immediate and Long-Term Effects of an 8-Week Digital Mental Health Intervention on Adults With Poorly Managed Type 2 Diabetes: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Eliane Boucher ◽  
Judith T Moskowitz ◽  
Gina M Kackloudis ◽  
Julia L Stafford ◽  
Ian Kwok ◽  
...  
Keyword(s):  
Mental Health ◽  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Long Term Effects ◽  
Randomized Controlled ◽  
Short And Long Term ◽  
Therapeutic Platform

BACKGROUND Diabetes is a leading cause of years of life lost and accounts for approximately one-fourth of health care dollars spent in the United States. Many of these costs are related to poor medication adherence and lack of self-care behaviors and are thus preventable. Depression, which is more prevalent among people with diabetes than in the general population, predicts poorer management of one’s diabetes, whereas positive affect predicts engaging in more positive health behaviors. Consequently, interventions that improve depression and positive affect may also improve diabetes-related outcomes among people with diabetes. Although preliminary research on the impact of such interventions among people with diabetes is promising, these studies focused primarily on in-person interventions, have had small samples, and lack long-term follow-up. OBJECTIVE This study aims to examine the short- and long-term effects of a digital therapeutic platform focused on mental health among adults with poorly managed type 2 diabetes and elevated levels of depression. METHODS This is a randomized controlled trial in which adults with a type 2 diabetes diagnosis, elevated hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) levels (≧7), and moderate to severe depressive symptoms will be randomly assigned to a positive emotion regulation skills intervention group or a sham digital intervention with only psychoeducational content. The study will take place over 14 months, including the 8-week intervention (or control) delivered via a digital therapeutic platform (Happify Health) and follow-up assessments at 3, 6, and 12 months postintervention. Throughout the intervention and for 1 week at each postintervention follow-up, participants will complete daily assessments of diabetes-related distress, diabetes regimen adherence, and mood. Our primary outcome, HbA<sub>1c</sub>, will be self-reported every 3 months throughout the study. Secondary and exploratory outcomes will be assessed at baseline; at 8 weeks; and at 3, 6, and 12 months postintervention. RESULTS Recruitment is expected to begin in June 2020. Participants will begin the study as they are recruited and will finish in waves. The final wave of data collection from the 8-week intervention is expected for winter 2020, with the completion of the 12-month follow-up in winter 2021. CONCLUSIONS Although previous research suggests that in-person psychological interventions have promising effects on both psychological and physical outcomes among adults with diabetes, digital interventions can be advantageous because they are easily scalable and reduce many barriers that prevent people from seeking treatment. This trial will provide important information about the effects of a digital mental health intervention among adults with type 2 diabetes, assessing both short- and long-term effects of this intervention on HbA1c, depressive symptoms, and other diabetes-specific outcomes. If successful, this may introduce a scalable intervention that would help reduce some of the preventable costs associated with diabetes. CLINICALTRIAL ClinicalTrials.gov NCT04068805; https://clinicaltrials.gov/ct2/show/NCT04068805. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/18578

A Randomized controlled trial of SMS Intervention in Inner Mongolia with Type 2 Diabetes (Preprint)

2018 ◽  
Author(s):  
Xue Mei Wang ◽  
Dan Liu ◽  
Mao Lin Du ◽  
Rui Qi Hao ◽  
Hui Qiu Zheng ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Blood Glucose ◽  
Weight Control ◽  
Controlled Trial ◽  
Average Score ◽  
Randomized Controlled ◽  
Sms Intervention ◽  
Better Than

BACKGROUND Nonadherence to self-management is common among patients with type 2 diabetes (T2D) and often leads to severe complications. Short messages service (SMS) technology provides a practical medium for delivering content to address patients’ barriers to adherence. OBJECTIVE The aim of this study was to design a series of SMS intervention templates, and to evaluate the feasibility of the SMS through a short message quality evaluation questionnaire and to explore the intervention effect. METHODS 1. The SMS evaluation was assessed through the 10-point scale SMS Quality Assessment Questionnaire. 2. A randomized controlled trial was conducted. The patients in SMS intervention were randomly divided into intervention group (IG) and control group (CG), which received evaluated messages education and regular education, respectively. The intervention was divided into four phases, a telephone interview was conducted to evaluate the effectiveness of the intervention after each phase. The main outcome were changes in blood glucose and blood pressure (BP) and their control rates, and secondary outcomes were changes in diet, physical activity, weight control and other health-related behaviors. RESULTS 1. SMS design: 42 SMS text messages were designed to promote healthy behaviors in different stages of behavior change, covering four key domains: healthy knowledge, diet, physical activity, living habits and weight control. 2. SMS evaluation: The average score for healthy knowledge, diet, physical activity, living habits, weight control were 8.0 (SD 0.7), 8.5 (SD 0.6), 7.9 (SD 1.0), 8.0 (SD 0.7), and 8.4 (SD 0.9), respectively. 3. SMS intervention: A total of 146 people completed the four-phase intervention, including 72 in the CG and 74 in the IG. At the end of the intervention period, in the IG, the decrease in fasting blood glucose (FBG, mean 1.5mg/l [SD 3.0] vs 0.4 mg/l [SD 2.8], P=0.011), postprandial blood glucose (PBG, mean 5.8mg/l [SD 5.1] vs 4.2 mg/l [SD 4.7], P=0.028), systolic blood pressure (SBP, mean 9.1mmHg [SD 15.8] vs 2.2mmHg [SD 13.3], P=0.025), FBG control rate (45.9% vs 31.0%, P=0.046) and PBG control rate (57.8% vs 33.7%, P=0.002) were better than the CG. In self-behavior management, the changes of the weight control, diet and physical activity in the IG were better than those in the CG, and the average score of the IG was greater than that of the CG (1.1 vs [-0.3] ), P0.001). CONCLUSIONS The overall quality of SMS content is higher to meet the needs of patients; Diet, physical activity and weight control message need to be focused on push. SMS interventions contribute to the management of blood glucose and BP, and help to promote a series of healthy-related behaviors.

scholarly journals How Family Physicians Practice the Principle of Remission Along the Glycemic Continuum

2020 ◽  
Vol 11 ◽  
pp. 215013272097774
Author(s):  
Stephanie T. Fulleborn ◽  
Paul F. Crawford ◽  
Jeremy T. Jackson ◽  
Christy J.W. Ledford
Keyword(s):  
Type 2 Diabetes ◽  
Medical Record ◽  
The United States ◽  
Case Scenario ◽  
Cross Sectional ◽  
Normal Glucose ◽  
Normal Glucose Regulation

Introduction Recent evidence reveals that diabetes and prediabetes (preDM) can be reversed to normal glucose regulation (NGR) through significant weight loss, but how physicians clinically identify the principles of partial and complete remission of diabetes is largely unknown. Methods As part of the cross-sectional omnibus survey conducted in March 2019 at a professional annual meeting in the United States, physician participants answered case scenario questions about the diagnosis and documentation of patients with preDM and type 2 diabetes (T2DM). Results Of the registered conference attendees, 387 (72.7%) responded. When presented with the initial case of preDM, 201 physicians (70.8%) selected R73.03 Prediabetes. In a follow-up encounter with improved lab results, 118 physicians (58.7%) indicated that they would not chart any diabetes-related code and 62 (30.8%) would chart preDM again. When presented with the case of T2DM, 256 physicians (90.1%) indicated E11.0–E11.9 Type 2 Diabetes. In the follow-up encounter, only 38 (14.8%) coded a diagnosis reflecting remission from T2DM to prediabetes and 211 (82.4%) charted T2DM. Conclusion Physicians may be reluctant to document diabetes regression as there is little evidence for long-term outcomes and “downgrading” the diagnosis in the medical record may cause screenings to be missed. Documenting this regression in the medical record should communicate the accurate point on the continuum of glucose intolerance with both the patient and the care team.

scholarly journals Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT)

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040117
Author(s):  
Carole Clair ◽  
Aurélie Augsburger ◽  
Priska Birrer ◽  
Isabella Locatelli ◽  
Joelle Schwarz ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Smoking Cessation ◽  
Smoking Cessation Intervention ◽  
Randomised Control Trial ◽  
Primary Study ◽  
Smoking Abstinence ◽  
Open Label ◽  
Cessation Intervention

IntroductionFew studies have assessed the efficacy of smoking cessation interventions in individuals with type 2 diabetes, but interventions adapted to the specific needs of this population are warranted. The aim of this study is to assess the efficacy of a smoking cessation intervention in a population of smokers with type 2 diabetes and to measure the metabolic impact of smoking cessation.Methods and analysisThe study is an open-label, randomised control trial. Participants recruited from a sanitary region of Switzerland will be randomly allocated to either the intervention or the control arm. The intervention group will have four individual counselling sessions over 12 weeks. Trained research nurses will conduct the behavioural intervention, using motivational interviews and addressing diabetes and gender specificities. The control group will have one short counselling session at baseline and will be given written information on smoking cessation. Both groups will have a follow-up visit at 26 and 52 weeks. Demographic and medical data will be collected at baseline and follow-up, along with blood and urine samples. The primary study outcome is continuous smoking abstinence validated by expired-air carbon monoxide from week 12 to week 52. Secondary study outcomes are continuous and 7-day point prevalence smoking abstinence at 12 and 26 weeks; change in motivation to quit and cigarette consumption; and change in glycosylated haemoglobin levels, body weight, waist circumference and renal function after smoking cessation. In a subsample of 80 participants, change in stool microbiota from baseline will be measured at 3, 8 and 26 weeks after smoking cessation.Ethics and disseminationEthical approval has been obtained by the competent ethics committee (Commission cantonale d’éthique de la recherche sur l’être humain, CER-VD 2017–00812). The results of the study will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numbersClinicalTrials.gov NCT03426423 and SNCTP000002762; Pre-results.

scholarly journals Long-term outcome of two forms of randomised benzodiazepine discontinuation

2006 ◽  
Vol 188 (2) ◽  
pp. 188-189 ◽  
Author(s):  
R. C. Oude Voshaar ◽  
W. J. M. J. Gorgels ◽  
A. J. J. Mol ◽  
A. J. L. M. Van Balkom ◽  
J. Mulder ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Randomised Controlled

SummaryAbouttwo-thirds of long-term users of benzodiazepines in the population are able to discontinue this drug with the aid of supervised programmes for tapering off. Little is known about the long-term outcome of such programmes, and they have never been compared with usual care. After a 15-month follow-up of a randomised controlled trial comparing such a programme with and without psychotherapy with usual care, we found significantly higher longitudinal abstinence rates in long-term benzodiazepine users who received a benzodiazepine tapering-off programme without psychotherapy (25 out of 69, 36%) compared with those who received usual care (5 out of 33, 15%; P=0.03).

564-P: Long-Term Follow-up of Glycemic Excursion Minimization (GEM) Compared with Weight Loss in Management of Type 2 Diabetes (T2D)

Diabetes ◽  
2021 ◽  
Vol 70 (Supplement 1) ◽  
pp. 564-P
Author(s):  
DANIEL COX ◽  
MATTHEW A. MONCRIEF ◽  
ANTHONY L. MCCALL
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Long Term Follow Up

scholarly journals Relative effectiveness of a full versus reduced version of the ‘Smoke Free’ mobile application for smoking cessation: a randomised controlled trial

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 1524 ◽  
Author(s):  
David Crane ◽  
Harveen Kaur Ubhi ◽  
Jamie Brown ◽  
Robert West
Keyword(s):  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Relative Effectiveness ◽  
Behaviour Change Techniques ◽  
Full Version ◽  
Intention To Treat ◽  
Support Programmes ◽  
Randomised Controlled

Background: Smartphone applications (apps) are popular aids for smoking cessation. Smoke Free is an app that delivers behaviour change techniques used in effective face-to-face behavioural support programmes. The aim of this study was to assess whether the full version of Smoke Free is more effective than the reduced version. Methods:  This was a two-arm randomised controlled trial. Smokers who downloaded Smoke Free were randomly offered the full or reduced version; 28,112 smokers aged 18+ years who set a quit date were included. The full version provided updates on benefits of abstinence, progress (days smoke free), virtual ‘badges’ and daily ‘missions’ with push notifications aimed at preventing and managing cravings. The reduced version did not include the missions. At baseline the app recorded users’: device type (iPhone or Android), age, sex, daily cigarette consumption, time to first cigarette of the day, and educational level. The primary outcome was self-reported complete abstinence from the quit date in a 3-month follow-up questionnaire delivered via the app. Analyses conducted included logistic regressions of outcome on to app version (full versus reduced) with adjustment for baseline variables using both intention-to-treat/missing-equals smoking (MES) and follow-up-only (FUO) analyses. Results: The 3-month follow-up rate was 8.5% (n=1,213) for the intervention and 6.5% (n=901) for the control. A total of 234 participants reported not smoking in the intervention versus 124 in the control, representing 1.6% versus 0.9% in the MES analysis and 19.3% versus 13.8% in the FUO analysis. Adjusted odds ratios were 1.90, 95%CI=1.53-2.37 (p<0.001) and 1.50, 95%CI=1.18-1.91 (p<0.001) in the MES and FUO analyses respectively. Conclusions: Despite very low follow-up rates using in-app follow up, both intention-to-treat/missing equals smoking and follow-up only analyses showed the full version of the Smoke Free app to result in higher self-reported 3-month continuous smoking abstinence rates than the reduced version.

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