Real-time continuous glucose monitoring versus self-monitoring of blood glucose in adults with insulin-treated type 2 diabetes: a protocol for a randomised controlled single-centre trial.

INTRODUCTION: Medical treatment options for type 2 diabetes (T2D) have increased over the last decade and enhance the possibility of individualised treatment strategies where insulin is still one of them. In spite of the advancements in treatment options, less than one-third of the population with T2D obtain their optimal glycaemic goal. In persons with type 1 diabetes, continuous glucose monitoring (CGM) has shown to be the most important driver for improvement in glycaemic control, even more than insulin-pump therapy. The use of technology in T2D has only been investigated in few studies.The overall objective of the research study is to examine the effectiveness of the use of CGM versus self-monitoring of blood glucose (SMBG) in persons with insulin-treated T2D on glycaemic variables and patient-reported outcomes on treatment satisfaction, health behaviour and well-being. The independent effect of peer support will also be studied. METHODS AND ANALYSIS: The study is a single centre, prospective, randomised, open-labelled, three-armed study with the randomisation 2:1:2 in group A with CGM, group B with CGM and peer support, and group C as a control group with SMBG. The participants receive a training course unique for the allocation group. The study runs for 12 months and includes 100 adult participants with insulin-treated T2D, treated at the outpatient clinic at Steno Diabetes Center Copenhagen. Primary outcome is difference in change in time in range. Recruitment begins in August 2020 and ends in July 2021. Final 12-month follow-up is anticipated to be in August 2022. ETHICS AND DISSEMINATION: The study will be carried out in accordance with the Helsinki Declaration and is approved by the Scientific Ethics Committee of the Capital Region (H-20000843). Data collection and handling will be performed in accordance with the General Data Protection Regulation and is approved by the Danish Data Protection Agency (J-2020-100). Dissemination will be in international peer-reviewed journals, conferences and a plain-language summary for participants. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04331444). PROTOCOL VERSION: V.3, 11 December 2020.

Genetic markers of abdominal obesity and weight loss after gastric bypass surgery.

BACKGROUND: Weight loss after bariatric surgery varies widely between individuals, partly due to genetic differences. In addition, genetic determinants of abdominal obesity have been shown to attenuate weight loss after dietary intervention with special attention paid to the rs1358980-T risk allele in the VEGFA locus. Here we aimed to test if updated genetic risk scores (GRSs) for adiposity measures and the rs1358980-T risk allele are linked with weight loss following gastric bypass surgery. METHODS: Five hundred seventy six patients with morbid obesity underwent Roux-en-Y gastric bypass. A GRS for BMI and a GRS for waist-hip-ratio adjusted for BMI (proxy for abdominal obesity), respectively, were constructed. All patients were genotyped for the rs1358980-T risk allele. Associations between the genetic determinants and weight loss after bariatric surgery were evaluated. RESULTS: The GRS for BMI was not associated with weight loss (ß = -2.0 kg/100 risk alleles, 95% CI -7.5 to 3.3, p = 0.45). Even though the GRS for abdominal obesity was associated with an attenuated weight loss response adjusted for age, sex and center (ß = -14.6 kg/100 risk alleles, 95% CI -25.4 to -3.8, p = 0.008), it was not significantly associated with weight loss after adjustment for baseline BMI (ß = -7.9 kg/100 risk alleles, 95% CI -17.5 to 1.6, p = 0.11). Similarly, the rs1358980-T risk allele was not significantly associated with weight loss (ß = -0.8 kg/risk allele, 95% CI -2.2 to 0.6, p = 0.25). DISCUSSION: GRSs for adiposity derived from large meta-analyses and the rs1358980-T risk allele in the VEGFA locus did not predict weight loss after gastric bypass surgery. The association between a GRS for abdominal obesity and the response to bariatric surgery may be dependent on the association between the GRS and baseline BMI.

"Mental Health Professionals Have Never Mentioned My Diabetes, They Don't Get Into That": A Qualitative Study of Support Needs in Adults With Type 1 and Type 2 Diabetes and Severe Mental Illness.

OBJECTIVES: People with severe mental illness (SMI) have a 2- to 3-fold higher risk of developing type 2 diabetes (DM), an increased risk of subsequent DM complications, higher mortality and poorer health-related quality of life. Although mental health professionals have an important role in supporting people with SMI in diabetes management, their primary focus is often on mental health, not physical conditions. Few studies have investigated patients' experiences of living with coexisting SMI and DM to identify their needs for diabetes support from mental health professionals. METHODS: Semistructured interviews were conducted with 15 adults with SMI and DM. Interviews were transcribed and analyzed using systematic text condensation. RESULTS: Five themes emerged from the data: 1) mental illness overshadows diabetes management, 2) mental state substantially influences diabetes care, 3) daily diabetes routines are challenging to maintain, 4) diabetes is burdensome and 5) dialogue about diabetes with mental health professionals is infrequent. CONCLUSIONS: Self-managing DM is extremely complex for patients who also live with SMI. Diabetes care is strongly influenced by emotional and mental states and the ability to establish daily routines. A need exists to enhance support from mental health professionals to improve DM self-management among people with mental illness. The present findings can inform the development of tailored interventions to support people with mental illness in DM self-management.