Guided self-determination intervention versus attention control for people with type 2 diabetes in outpatient clinics: a protocol for a randomised clinical trial

IntroductionIn the management of type 2 diabetes, autonomy-supporting interventions may be a prerequisite to achieving more long-term improvement. Preliminary evidence has shown that the guided self-determination (GSD) method might have an effect on haemoglobin A1c and diabetes distress in people with type 1 diabetes. Previous trials were at risk of uncertainty. Thus, the objective is to investigate the benefits and harms of a GSD intervention versus an attention control group intervention in adults with type 2 diabetes.Methods and analysisThis trial protocol is guided by the The Standard Protocol Items: Recommendations for International Trials Statement. We describe the protocol for a pragmatic randomised, dual-centre, parallel-group, superiority clinical trial testing a GSD intervention versus an attention control for people with type 2 diabetes in outpatient clinics. The participants (n=224) will be recruited from two diverse regions of Denmark. The experimental stepped-care intervention will consist of three to five GSD sessions lasting up to 1 hour with a trained GSD facilitator. The sessions will be conducted face to face, by video conference or over the telephone. The attention controls will receive three to five sessions lasting up to an hour with a communication-trained healthcare professional provided face to-face, by video conference, or over the telephone. Participants will be included if they have type 2 diabetes,>18 years old, are not pregnant. Participants will be assessed before randomisation, at 5-month, and 12-month follow-up, the latter being the primary. The primary outcome is diabetes distress. Secondary outcomes are quality of life, depressive symptoms and non-serious adverse events. Exploratory outcomes are haemoglobin A1c, motivation and serious adverse events. Data will be collected using REDCap and analysed using Stata V.16.Ethics and disseminationThe trial will be conducted in compliance with the protocol, the Helsinki Declaration in its latest form, International Harmonisation of Good Clinical Practice guidelines and the applicable regulatory requirement(s). The trial has been approved by the Danish Data Protection Agency (P-2020-864). The Ethics Committee of the Capital Region of Denmark reviewed the trial protocol, but exempted the trial protocol from full review (H-20003638). The results of the trial will be presented at the outpatient clinics treating people with type 2 diabetes, at national and international conferences as well as to associations for people with diabetes and their relatives.Trial registration numberClinicalTrials.gov identifier: NCT04601311.

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The effectiveness of an emotion-focused educational programme in reducing diabetes distress in adults with type 2 diabetes mellitus at 12-month follow-up: a cluster randomized controlled trial

Therapeutic Advances in Endocrinology and Metabolism ◽

10.1177/2042018819853761 ◽

2019 ◽

Vol 10 ◽

pp. 204201881985376

Author(s):

Boon-How Chew ◽

Rimke C. Vos ◽

Aaron Fernandez ◽

Sazlina Shariff Ghazali ◽

Nurainul Hana Shamsuddin ◽

...

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Clinical Medicine ◽

Controlled Trial ◽

Control Program ◽

Attention Control ◽

Diabetes Distress ◽

Control Group

Background: Diabetes distress (DD) is an increasingly important part of clinical medicine, diabetes self-management and research topic in people with diabetes mellitus. The present study evaluated the effectiveness of a value-based emotion-focused educational program in Malay adults with type 2 diabetes (VEMOFIT) at 12-month follow-up compared with a program with systematic attention to participants’ emotions (attention-control). Methods: VEMOFIT consisted of four biweekly group sessions and a booster session after 3 months; the attention-control program consisted of three sessions over the same period. Intention-to-treat analysis with multilevel mixed modelling was done to estimate the intervention effect. Results: Participants ( n = 124) randomized to VEMOFIT ( n = 53) or attention-control ( n = 71). Mean (SD) age 55.7 (9.7) years, median diabetes duration 7.0 (8.0) years and mean HbA1c level 9.7% (82 mmol/mol). The mean DD (DDS-17 scale) level decreased in both groups (from 3.4 to 3.3 versus 3.1–2.5, respectively), significantly more in the attention-control group [adjusted difference −0.6, 95% confidence interval (CI) −1.1, −0.2]. The VEMOFIT group had a significant improvement in self-efficacy (DMSES, range 0–200; adjusted difference 16.4, 99.4% CI 1.9, 30.9). Other outcomes did not differ. Conclusions: Because the attention-control program resulted in a decreased DD 1 year later, its implementation on a larger scale seems justified. Trial registration: NCT02730078; NMRR-15-1144-24803

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Feasibility and acceptance of a virtual multidisciplinary care programme for patients with type 2 diabetes during the COVID-19 pandemic

Therapeutic Advances in Endocrinology and Metabolism ◽

10.1177/20420188211059882 ◽

2021 ◽

Vol 12 ◽

pp. 204201882110598

Author(s):

Sergio Hernández-Jiménez ◽

Ana Cristina García-Ulloa ◽

María Teresa Alcántara-Garcés ◽

Luz Elena Urbina-Arronte ◽

Carolina Lara-Sánchez ◽

...

Keyword(s):

Type 2 Diabetes ◽

Self Care ◽

Comprehensive Care ◽

Metabolic Parameters ◽

Diabetes Distress ◽

Foot Care ◽

Care Programme ◽

Face To Face ◽

Emotional Factors

Background and aims: Type 2 diabetes mellitus is one of the major public health concerns. The current lifestyle and advances in technology resulted in the development of a virtual mode of professional healthcare, which is an effective alternative method of management of patients. This study aimed to assess the feasibility of implementation of a virtual comprehensive care programme during the COVID-19 pandemic, patients’ acceptance and the changes in self-care behaviours, metabolic parameters and emotional factors. Methods: The programme employed in this study included nine health interventions in 1 day. Due to the COVID-19 pandemic, the mode of interventions, including questionnaires, patient evaluations and a satisfaction survey, was modified to the virtual form in 2020. This study assessed the changes in self-care behaviours, metabolic parameters and emotional factors and compared the data pertaining to patients who received virtual healthcare in 2020 with those who received face-to-face modality of medical care in 2019. Results: During June to November 2020, 130 patients received healthcare by means of the virtual modality. The change in modality of healthcare was feasible and 75% of the patients displayed good acceptance of the same. The evaluation of self-care behaviours included self-monitoring blood glucose (SMBG) levels, foot care and regular exercise. The duration of exercise decreased from 120 to 0 min/week ( p < 0.001). However, there was no change in metabolic parameters. Regarding the mental health parameters, we observed an increase in the proportion of patients with anxiety (21.5% versus 11.1%), depressive symptoms (10.8% versus 4.3%), diabetes distress (18.5% versus 11.1%) and prescription of psychotropic drugs (32.8% versus 18.2%) ( p < 0.05) in virtual versus face-to-face, respectively. Conclusion: The virtual comprehensive care programme for the management of patients with diabetes is a feasible approach that allows healthcare professionals to provide an adequate care during the COVID-19 pandemic.

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Comparison of E-Consults and Face-to-Face Care on Costs and Glycemic Control among Veterans with Type 2 Diabetes Mellitus

Diabetes ◽

10.2337/db18-137-lb ◽

2018 ◽

Vol 67 (Supplement 1) ◽

pp. 137-LB ◽

Cited By ~ 1

Author(s):

NEHA KARAJGIKAR ◽

KARLA B. DETOYA ◽

JANICE N. BEATTIE ◽

STACEY J. LUTZ-MCCAIN ◽

MONIQUE Y. BOUDREAUX-KELLY ◽

...

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Glycemic Control ◽

Face To Face

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Outcomes of a digitally delivered, culturally-sensitive behaviour change platform for BAME adults with type 2 diabetes: 1 year health and engagement outcomes (Preprint)

10.2196/preprints.18674 ◽

2020 ◽

Author(s):

Charlotte Summers

Keyword(s):

Type 2 Diabetes ◽

Body Weight ◽

Health Outcomes ◽

Behavioural Change ◽

Culturally Sensitive ◽

Lifestyle Changes ◽

Haemoglobin A1c ◽

Central Asian ◽

Increased Risk

BACKGROUND People from Black, Asian and Minority Ethnic (BAME) groups are known to have an increased risk of developing type 2 diabetes and face greater barriers to accessing healthcare resources compared to their “white British” counterparts. The main mediators of lifestyle behavioural change are gender, generation, geography, genes, God/religion, and gaps in knowledge and economic resources. Dietary and cultural practices of these individuals significantly vary according to gender, generation, geographical origin and religion. Recognition of these factors and implementing culturally sensitive interventions for type 2 diabetes prevention and management is essential in increasing knowledge of healthy eating, engagement in physical activity and improving health outcomes in BAME communities. Few health apps are tailored for BAME populations, and BAME communities are considered hard-to-reach. OBJECTIVE Our objective was to establish whether the Low Carb Program is a viable scalable solution that can be used as an effective tailored type 2 diabetes intervention for BAME communities. We hypothesized that by taking into account cultural sensitivities, providing the platform in native languages and personalising the platform in accordance with known barriers to health disparities including gender, generation, dietary preferences and religion, the app would engage BAME communities and improve type 2 diabetes related health outcomes. METHODS The study used a quasi-experimental research design comprised of an open-label, single-arm, pre-post intervention using a sample of convenience. All 705 adults with type 2 diabetes who had activated their referral to the Low Carb Program as a result of an NHS consultation between September 2018 and March 2019 were followed for a period of 12 months; mean age 54.61 (SD 16.69) years; 58.2% (410/705) women; 45.1% (318/705) white, 28.5% (201/705) Indian/Pakistani/Bangladeshi/Other Central Asian, 10.8% (76/705) Arab, 6.2% (44/705) Mixed/Multiple ethnic groups, 6% (43/705) black, 1.8% (13/705) other, (7/705) 1% Chinese/Japanese/Other East Asian. Mean starting glycated haemoglobin A1c (HbA1c) 7.99% (SD 2.05%); mean body weight 88.96kg (SD 23.25kg). RESULTS Of the 705 study participants, 513 (72.76%) had completed the Low Carb Program at 12 months. There were statistically significant reductions in body weight and HbA1c in white, Indian/Pakistani/Bangladeshi/Other Central Asian, Arabic and black participants with the most significant differences in the Indian/Pakistani/Bangladeshi/Other Central Asian population HbA1c -1.18% (SD 1.49%) and weight 8.03kg (SD 10.65kg). 82.9% of all participants (419/705) of all participants lost at least 5% of their body weight. CONCLUSIONS Offering the culturally tailored Low Carb Program that empowers members to make dietary and lifestyle changes to different BAME groups is an effective and engaging tool in the management of type 2 diabetes. Most importantly, BAME populations in particular people from Indian/Pakistani/Bangladeshi and Arabic groups who achieve better health outcomes than their white counterparts.

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Effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes: a systematic review protocol

BMJ Open ◽

10.1136/bmjopen-2020-044888 ◽

2021 ◽

Vol 11 (3) ◽

pp. e044888

Author(s):

Rita McMorrow ◽

Barbara Hunter ◽

Christel Hendrieckx ◽

Dominika Kwasnicka ◽

Leanne Cussen ◽

...

Keyword(s):

Systematic Review ◽

Type 2 Diabetes ◽

Outcome Measures ◽

Study Design ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Diabetes Distress ◽

Controlled Trials ◽

Patient Reported

IntroductionType 2 diabetes is a global health priority. People with diabetes are more likely to experience mental health problems relative to people without diabetes. Diabetes guidelines recommend assessment of depression and diabetes distress during diabetes care. This systematic review will examine the effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes.Methods and analysisMEDLINE, Embase, CINAHL Complete, PsycInfo, The Cochrane Library and Cochrane Central Register of Controlled Trials will be searched using a prespecified strategy using a prespecified Population, Intervention, Comparator, Outcomes, Setting and study design strategy. The date range of the search of all databases will be from inception to 3 August 2020. Randomised controlled trials, interrupted time-series studies, prospective and retrospective cohort studies, case–control studies and analytical cross-sectional studies published in peer-reviewed journals in the English language will be included. Two review authors will independently screen abstracts and full texts with disagreements resolved by a third reviewer, if required, using Covidence software. Two reviewers will undertake risk of bias assessment using checklists appropriate to study design. Data will be extracted using prespecified template. A narrative synthesis will be conducted, with a meta-analysis, if appropriate.Ethics and disseminationEthics approval is not required for this review of published studies. Presentation of results will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidance. Findings will be disseminated via peer-reviewed publication and conference presentations.PROSPERO registration numberCRD42020200246.

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A study on diabetes-related distress among type 2 diabetes mellitus patients using the diabetes distress scale in a tertiary care center in Telangana

International Journal of Diabetes in Developing Countries ◽

10.1007/s13410-021-00937-5 ◽

2021 ◽

Author(s):

K. Sumana ◽

Shehzad Ruman ◽

M. Beatrice Anne ◽

Shiva Krishna Katkam

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Care Center ◽

Tertiary Care ◽

Diabetes Distress ◽

Tertiary Care Center ◽

Distress Scale ◽

Diabetes Distress Scale

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Sex differences and correlates of poor glycaemic control in type 2 diabetes: a cross-sectional study in Brazil and Venezuela

BMJ Open ◽

10.1136/bmjopen-2018-023401 ◽

2019 ◽

Vol 9 (3) ◽

pp. e023401 ◽

Cited By ~ 5

Author(s):

Fernanda G Duarte ◽

Sandra da Silva Moreira ◽

Maria da Conceição C Almeida ◽

Carlos A de Souza Teles ◽

Carine S Andrade ◽

...

Keyword(s):

Type 2 Diabetes ◽

Glycaemic Control ◽

Treatment Guidelines ◽

Specific Treatment ◽

Nationwide Survey ◽

Haemoglobin A1c ◽

Cross Sectional ◽

Factors Associated ◽

Adherence To Diet

ObjectiveExamine whether glycaemic control varies according to sex and whether the latter plays a role in modifying factors associated with inadequate glycaemic control in patients with type 2 diabetes (T2D) in Brazil and Venezuela.Design, setting and participantsThis was a cross-sectional, nationwide survey conducted in Brazil and Venezuela from February 2006 to June 2007 to obtain information about glycaemic control and its determinants in patients with diabetes mellitus attending outpatient clinics.Main outcome measuresHaemoglobin A1c (HbA1c) level was measured by liquid chromatography, and patients with HbA1c ≥7.0% (53 mmol/mol) were considered to have inadequate glycaemic control. The association of selected variables with glycaemic control was analysed by multivariate linear regression, using HbA1c as the dependent variable.ResultsA total of 9418 patients with T2D were enrolled in Brazil (n=5692) and in Venezuela (n=3726). They included 6214 (66%) women and 3204 (34%) men. On average, HbA1c levels in women were 0.13 (95% CI 0.03 to 0.24; p=0.015) higher than in men, after adjusting for age, marital status, education, race, country, body mass index, duration of disease, complications, type of healthcare, adherence to diet, adherence to treatment and previous measurement of HbA1c. Sex modified the effect of some factors associated with glycaemic control in patients with T2D in our study, but had no noteworthy effect in others.ConclusionsWomen with T2D had worse glycaemic control than men. Possible causes for poorer glycaemic control in women compared with men include differences in glucose homeostasis, treatment response and psychological factors. In addition, sex modified factors associated with glycaemic control, suggesting the need to develop specific treatment guidelines for men and women.

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Validity of the Finnish Diabetes Risk Score for Detecting Undiagnosed Type 2 Diabetes among General Medical Outpatients in Botswana

Journal of Diabetes Research ◽

10.1155/2016/4968350 ◽

2016 ◽

Vol 2016 ◽

pp. 1-7 ◽

Cited By ~ 11

Author(s):

Bernard Omech ◽

Julius Chacha Mwita ◽

Jose-Gaby Tshikuka ◽

Billy Tsima ◽

Oathokwa Nkomazna ◽

...

Keyword(s):

Type 2 Diabetes ◽

Risk Score ◽

Predictive Value ◽

Total Population ◽

Diabetes Risk ◽

Undiagnosed Diabetes ◽

Haemoglobin A1c ◽

Diabetes Risk Score ◽

Medical Outpatients

This was a cross-sectional study designed to assess the validity of the Finnish Diabetes Risk Score for detecting undiagnosed type 2 diabetes among general medical outpatients in Botswana. Participants aged ≥20 years without previously diagnosed diabetes were screened by (1) an 8-item Finnish diabetes risk assessment questionnaire and (2) Haemoglobin A1c test. Data from 291 participants were analyzed (74.2% were females). The mean age of the participants was 50.1 (SD = ±11) years, and the prevalence of undiagnosed diabetes was 42 (14.4%) with no significant differences between the gender (20% versus 12.5%,P=0.26). The area under curve for detecting undiagnosed diabetes was 0.63 (95% CI 0.55–0.72) for the total population, 0.65 (95% CI: 0.56–0.75) for women, and 0.67 (95% CI: 0.52–0.83) for men. The optimal cut-off point for detecting undiagnosed diabetes was 17 (sensitivity = 48% and specificity = 73%) for the total population, 17 (sensitivity = 56% and specificity = 66%) for females, and 13 (sensitivity = 53% and specificity = 77%) for males. The positive predictive value and negative predictive value were 20% and 89.5%, respectively. The findings indicate that the Finnish questionnaire was only modestly effective in predicting undiagnosed diabetes among outpatients in Botswana.

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