The prevention of adverse pregnancy outcomes by periodontal treatment during pregnancy (PROBE) intervention study-A controlled intervention study: Protocol paper.

INTRODUCTION: Pregnancy increases the risk of periodontitis due to the increase in progesterone and estrogen. Moreover, periodontitis during pregnancy is associated with development of pregnancy and birth related complications. The aim of this study is to determine, whether periodontal treatment during pregnancy can reduce systemic inflammation and lower the risk of adverse pregnancy and birth related outcomes. METHODS AND ANALYSIS: The PROBE study is a non-randomized controlled intervention study conducted among 600 pregnant women with periodontitis. The women will be recruited among all pregnant women at two Danish hospitals in Region Zealand during their nuchal translucency scan and will subsequently be screened for periodontitis. The intervention group includes 300 pregnant women, who will be offered state-of-the-art periodontal treatment during pregnancy. The control group includes additional 300 pregnant women, who will be offered periodontal treatment after giving birth. Outcome measures include periodontal measures, inflammatory, hormonal and glycaemic markers as well as the prevalence of preterm birth risk, low birth weight and risk markers of gestational diabetes mellitus (GDM) and preeclampsia that will be collected from all screened women and further during pregnancy week 20 and pregnancy week 35 for women enrolled in the intervention. ETHICS AND DISSEMINATION: The study's findings will be published in peer reviewed journals and disseminated at national and international conferences and through social media. The PROBE study is designed to provide important new knowledge as to whether periodontal treatment during pregnancy can reduce the prevalence of complications related to pregnancy and birth. CLINICAL TRIALS REGISTRATION: The study was registered on clinicaltrials.gov (NCT06110143).

Loneliness and the risk of type 2 diabetes.

INTRODUCTION: The incidence of type 2 diabetes is increasing globally. Recent research suggests that loneliness could be a potential risk factor for the development of type 2 diabetes. We aimed to investigate the association between loneliness and type 2 diabetes and the modifying effect of mental disorders. RESEARCH DESIGN AND METHODS: We conducted a prospective study including 465 290 adults (aged ≥16 years) who participated in either the Danish Health and Morbidity Survey or the Danish National Health Survey between 2000 and 2017. Loneliness was based on self-report, while type 2 diabetes was measured using an algorithm combining several health registers including type 2 diabetes patients treated both within the hospital sector and general practice. Cox proportional hazards regressions were used to estimate hazard ratios (HRs) and 95% confidence intervals (95% CIs). RESULTS: During a mean follow-up time of 6.3 years, 13 771 individuals (3%) developed type 2 diabetes. Feeling lonely once in a while was associated with a 14% increased risk of type 2 diabetes (95% CI 1.09 to 1.20), while feeling lonely often was associated with a 24% increased risk (95% CI 1.14 to 1.34), independent of sociodemographic factors and body mass index. The association was stronger among individuals without a mental disorder (HR 1.21, 95% CI 1.10 to 1.34 among those feeling lonely often) compared with those with a mental disorder (HR 1.07, 95% CI 0.93 to 1.23). CONCLUSIONS: Loneliness independently increased the risk of type 2 diabetes. The effect was more pronounced in individuals without a mental disorder, as having a mental disorder itself likely increases the risk of type 2 diabetes. These findings emphasize the importance of addressing loneliness as a modifiable risk factor in preventing type 2 diabetes.

The Fusion Clinic: Integrating the care of people with severe mental illness and diabetes.

AIM: People with coexisting severe mental illness (SMI) and type 2 diabetes have a shorter life expectancy and poorer diabetes outcomes than those without SMI. This is partly explained by the separate treatment of diabetes and SMI, which occurs in parallel silos in many healthcare systems. The Steno Diabetes Center Sjaelland and Region Zealand established the Fusion Clinic to offer combined psychiatric and diabetes care delivered by both diabetes and mental healthcare professionals. This study describes how the clinic was established and the initial diabetes outcomes. METHODS: The Fusion Clinic was co-designed by people with diabetes and SMI and healthcare professionals to improve the care of adults with diabetes and SMI. The clinic approach utilised the F-ACT model. The 63 people referred to the Fusion Clinic between 01.02.2020 and 01.01.2022 who attended the clinic for more than 6 months were included in this study. Diabetes outcomes were recorded in the electronic medical records (Sundhedsplatformen EPIC). RESULTS: There was a high prevalence of diabetes complications at baseline. Furthermore, 70% had one or more additional concomitant diseases, as well as SMI and diabetes. Assessment of diabetes complications and measurements of HbA1c and lipid profile improved after referral to the clinic. HbA1c declined during the first 6 months of attendance at the clinic. CONCLUSIONS: This model of service delivery has the potential to improve the quality of care for people with SMI and type 2 diabetes.

Diabetic complications and risk of depression and anxiety among adults with type 2 diabetes.

AIMS: To investigate if diabetic complications increase the risk of depression and/or anxiety among adults with type 2 diabetes. METHODS: This register-based, prospective study included 265,799 adult individuals diagnosed with type 2 diabetes between 1997 and 2017 without a recent history of depression or anxiety. Diabetic complications included cardiovascular disease, amputation of lower extremities, neuropathy, nephropathy and retinopathy. Both diabetic complications and depression and anxiety were defined by hospital contacts and prescription-based medication. All individuals were followed from the date of type 2 diabetes diagnosis until the date of incident depression or anxiety, emigration, death or 31 December 2018, whichever occurred first. RESULTS: The total risk time was 1,915,390 person-years. The incidence rate of depression and/or anxiety was 3368 per 100,000 person-years among individuals with diabetic complications and 1929 per 100,000 person-years among those without. Having or developing any diabetic complication was associated with an increased risk of depression and/or anxiety (HR 1.77, 95% CI 1.73-1.80). The risk for depression and/or anxiety was increased for all types of diabetic complications. The strongest association was found for amputation of lower extremities (HR 2.16, 95% CI 2.01-2.31) and the weakest for retinopathy (HR 1.13, 95% CI 1.09-1.17). CONCLUSION: Individuals with type 2 diabetes and diabetic complications are at increased risk of depression and anxiety. This points towards the importance of an increased clinical focus on mental well-being among individuals with type 2 diabetes and complications.

Men's Experiences With Managing Type 2 Diabetes and Their Encounters With Health Professionals: A Scoping Review.

Type 2 diabetes is on the rise globally, and previous research has identified gender as one known risk factor for developing this disease. Gender has also been reported to affect patients' experiences of managing type 2 diabetes. However, little is known of men's specific experiences with type 2 diabetes, as research with a gendered focus has concentrated more on women's experiences with the disease. This scoping review explores how research has addressed men's experiences of managing type 2 diabetes and their encounters with health professionals. The review consists of an iterative process, involving six steps: identification of the research questions, identification of relevant studies, study selection, charting the data, collating and summarizing results, and consultation with external stakeholders. Through the process, 28 publications were identified, which indicate a gap in research on patients' experiences with type 2 diabetes. The majority of the identified studies focuses on men from an ethnic minority due to their poorer health outcomes. However, a knowledge gap regarding men belonging to an ethnic or racial majority warrants further attention, as studies indicate that men who share similar social economic status face similar barriers to improving the management of type 2 diabetes. There is little discussion of how the gendered dynamics in encounters between patients and health professionals affect the management of type 2 diabetes. This review suggests a need for further research that explores how practices of masculinities, that is, the normative practices guiding men's behavior, intersect with men's experiences with type 2 diabetes in a broader perspective.

What do persons with diabetes want from community pharmacies? A qualitative study.

Background: Diabetes is a demanding disease with a complex treatment regimen. Many persons with diabetes have difficulty managing their disease and taking medication as prescribed, possibly because they lack knowledge and sometimes misinterpret medical benefits. Community pharmacies continuously provide professional counselling to persons with diabetes. Objective: This study aimed to explore 1) which services adults with type 1 and type 2 diabetes want from community pharmacies and 2) how pharmacies can meet these wishes. Methods: A qualitative, explorative study design using focus group interviews was chosen. Informants were recruited from Region Zealand in Denmark. Data were digitally recorded, transcribed verbatim and analyzed by means of thematic analysis. Results: Thirteen adults (11 female) with the mean age of 66.2 years (range 49-81 years) participated in one physical (n=6) or one online (n=7) focus group interview. Ten had type 2 diabetes, three had type 1 diabetes. The average duration of participants' diabetes was 13.4 years (range 2.3-33.0 years). The analysis revealed three overall themes of the functions which the informants would like community pharmacies to fulfil: 1) raise awareness of pharmacies' counselling service and competences; 2) act as a dialogue partner; 3) be a source of information and guidance about local activities and support. Conclusion: The informants did not regard community pharmacies as a natural part of the healthcare system or as a place where they would expect counselling. They would like the community pharmacy to make their medical competences and services obvious and the community pharmacy staff to act as a dialogue partner and provide competent counselling. The informants would like to have a contact person with diabetes competences with whom they can book an appointment to complement over-the-counter counselling. They experience a gap in their care between routine visits in the healthcare system and suggest that community pharmacies counselling services become a natural supplement and that healthcare professionals in the primary and secondary sectors inform patients about the services - especially for patients newly diagnosed with diabetes. Finally, they would like a formal collaboration between diabetes associations and community pharmacies to make their competences, services and information visible.

What do persons with diabetes want from community pharmacies? A qualitative study

Background: Diabetes is a demanding disease with a complex treatment regimen. Many persons with diabetes have difficulty managing their disease and taking medication as prescribed, possibly because they lack knowledge and sometimes misinterpret medical benefits. Community pharmacies continuously provide professional counselling to persons with diabetes. Objective: This study aimed to explore 1) which services adults with type 1 and type 2 diabetes want from community pharmacies and 2) how pharmacies can meet these wishes. Methods: A qualitative, explorative study design using focus group interviews was chosen. Informants were recruited from Region Zealand in Denmark. Data were digitally recorded, transcribed verbatim and analyzed by means of thematic analysis. Results: Thirteen adults (11 female) with the mean age of 66.2 years (range 49–81 years) participated in one physical (n=6) or one online (n=7) focus group interview. Ten had type 2 diabetes, three had type 1 diabetes. The average duration of participants’ diabetes was 13.4 years (range 2.3–33.0 years). The analysis revealed three overall themes of the functions which the informants would like community pharmacies to fulfil: 1) raise awareness of pharmacies’ counselling service and competences; 2) act as a dialogue partner; 3) be a source of information and guidance about local activities and support. (AU)

Reimbursement of glitazones in treatment of type 2 diabetes patients in Denmark in the context of a voluntary system for submitting pharmacoeconomic studies.

In 1998, guidelines for pharmacoeconomic evaluation were issued in Denmark. It was left to the discretion of the industry for which products to submit a pharmacoeconomic study. The impact of this voluntary system is illustrated by a case study on reimbursement of two types of glitazones. A review is presented of the evidence on safety, effectiveness and cost-effectiveness of glitazones that was available in the public domain at the time of reimbursement decision making, which was matched to the Danish criteria for general reimbursement of new pharmaceuticals. The study concludes that the voluntary system has not supported the inclusion of efficiency considerations in reimbursement decision making on glitazones. The decision-making process may be improved by mandatory pharmacoeconomic evaluations for selected products such as glitazones, which potentially represent a benefit to patients and potentially improve the cost-effectiveness of care, while at the same time having a considerable budget impact.