Search

Aims: To explore the feasibility and potential benefits of a peer support programme for adults with insulin‐treated type 2 diabetes (T2D) starting continuous glucose monitoring (CGM). Methods: This part of the Steno2tech study is an exploratory, single‐centre, open‐labelled, prospective, randomised controlled trial (RCT). A total of 60 participants were randomised 2:1 to 12 months of CGM with or without peer support. All participants received a 3‐h diabetes self‐management education course including a CGM part on how to use the CGM and interpret the CGM‐derived data. Peer support consisted of three 3‐h peer support meetings over the first 6 months of the study period with groups of three to six people. The exploratory outcomes included the acceptability and feasibility of the peer support intervention, and the between‐group difference in change in several glycaemic, metabolic and participant‐reported outcomes measured at baseline, 6 and 12 months. Results: The peer support intervention was found acceptable and feasible. Participants shared their experiences of using and interpreting CGM data and its association with health behaviour. While both groups had improvements in glycaemic, metabolic and participant‐reported outcomes, there were no significant between‐group differences. Conclusions: Although feasible, we found no measured additional benefits when adding a peer support programme after starting CGM in this exploratory RCT including adults with insulin‐treated T2D. Understanding the perceived effect of and preferences for a peer support intervention from the participants' points of view, including why individuals declined to participate, would be of value for future research. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To compare the 12-month effects of continuous glucose monitoring (CGM) versus blood glucose monitoring (BGM) in adults with insulin-treated type 2 diabetes. RESEARCH DESIGN AND METHODS: This is a single-center, parallel, open-label, randomized controlled trial including adults with inadequately controlled, insulin-treated type 2 diabetes from the outpatient clinic at Steno Diabetes Center Copenhagen, Denmark. Inclusion criteria were ≥18 years of age, insulin-treated type 2 diabetes, and HbA1c ≥7.5% (58 mmol/mol). Participants were randomly assigned (1:1) to 12 months of either CGM or BGM. All participants received a diabetes self-management education course and were followed by their usual health care providers. Primary outcome was between-group differences in change in time in range (TIR) 3.9–10.0 mmol/L, assessed at baseline, after 6 and 12 months by blinded CGM. The prespecified secondary outcomes were differences in change in several other glycemic, metabolic, and participant-reported outcomes. RESULTS: The 76 participants had a median baseline HbA1c of 8.3 (7.8, 9.1)% (67 [62–76] mmol/mol), and 61.8% were male. Compared with BGM, CGM usage was associated with significantly greater improvements in TIR (between-group difference 15.2%, 95% CI 4.6; 25.9), HbA1c (−0.9%, −1.4; −0.3 [−9.4 mmol/mol, −15.2; −3.5]), total daily insulin dose (−10.6 units/day, −19.9; −1.3), weight (−3.3 kg, −5.5; −1.1), and BMI (−1.1 kg/m2, −1.8; −0.3) and greater self-rated diabetes-related health, well-being, satisfaction, and health behavior. CONCLUSIONS: In adults with inadequately controlled insulin-treated type 2 diabetes, the 12-month impact of CGM was superior to BGM in improving glucose control and other crucial health parameters. The findings support the use of CGM in the insulin-treated subgroup of type 2 diabetes. [ABSTRACT FROM AUTHOR]

OBJECTIVE--To investigate the effect of flexible intensive insulin therapy (FIIT) and an automated bolus calculator (ABC) in a Danish type 1 diabetes population treated with multiple daily injections. Furthermore, to test the feasibility of teaching FIIT in a 3-h structured course. RESEARCH DESIGN AND METHODS--The BolusCal Study was a 16-week randomized, controlled, open-label, three-arm parallel, clinical study of 51 adults with type 1 diabetes. Patients aged 18-65 years in poormetabolic control (HbA1c 8.0-10.5%) were randomized to the Control (n = 8), CarbCount (n = 21), or CarbCountABC (n = 22) arm. During a 3-h group teaching, the Control arm received FIIT education excluding carbohydrate counting. CarbCount patients were taught FIIT and how to count carbohydrates. CarbCountABC group teaching included FIIT and carbohydrate counting and patients were provided with an ABC. RESULTS--At 16 weeks, the within-group change in HbA1c was20.1% (95% CI21.0 to 0.7%; P = 0.730) in the Control arm, 20.8% (21.3 to 20.3%; P = 0.002) in the CarbCount arm, and 20.7%(21.0 to20.4%; P<0.0001) in the CarbCountABCarm. The difference in change in HbA1c between CarbCount and CarbCountABC was insignificant. Adjusting for baseline HbA1c in a regression model, the relative change in HbA1c was 20.6% (21.2 to 0.1%; P = 0.082) in CarbCount and 20.8% (21.4 to 20.1%; P = 0.017) in CarbCountABC. Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (status version) improved in all study arms, but the improvement was significantly greater in CarbCountABC. CONCLUSIONS--FIIT and carbohydrate counting were successfully taught in 3 h and improved metabolic control and treatment satisfaction. Concurrent use of an ABC improved treatment satisfaction further. [ABSTRACT FROM AUTHOR]

• Little is known about real-world effects of initiating insulin pump therapy (IPT). • IPT, on average, reduces HbA 1c and HbA 1c variability, compared with injections. • IPT, on average, increases the risk of hospitalised diabetic ketoacidosis. • IPT, on average, does not affect the risk of hospitalised severe hypoglycaemia. • Women, older individuals, and the higher educated benefit most from initiating IPT. We aimed to estimate effects of insulin pump therapy (IPT) on HbA 1c level, HbA 1c variability, and risk of hospitalised diabetic ketoacidosis (DKA) and severe hypoglycaemia (SH), compared with multiple daily insulin injections (MDI). We identified a cohort of all adults with type 1 diabetes in Denmark using national registry data and assigned each individual to either IPT (treatment) or MDI (control) from 2010 to 2020. We estimated average treatment effects on the treated (ATT) and treatment effects among population subgroups using treatment-staggered difference-in-differences. The cohort consisted of 26,687 individuals with a collective 243,601 person-years of observation; 38,823 (16 %) were IPT person-years. We identified an ATT for HbA 1c of −0.33 % (95 % CI −0.39 to −0.27; −3.6 mmol/mol [95 % CI −4.2 to −2.9]). ATTs were larger among women and individuals who were older, had highest baseline HbA 1c , and used continuous glucose monitoring. ATT for HbA 1c variability (−0.016 % [−0.028 to −0.0041); −0.17 mmol/mol [95 % CI −0.30 to −0.045]) corresponded to a 6.5 % decrease in the standard deviation of HbA 1c. ATTs for DKA and SH corresponded to 0.52 additional and 0.11 fewer hospitalisations per 1,000 person-years, respectively. IPT significantly reduced HbA 1c level and variability, compared with MDI. However, it also marginally increased the risk of hospitalised DKA. [ABSTRACT FROM AUTHOR]

Introduction: The study aimed to investigate independent and combined associations between insulin delivery method (insulin pump therapy (IPT) vs multiple daily injections (MDI)), glucose monitoring method (intermittently scanned continuous glucose monitoring (isCGM) and real-time continuous glucose monitoring (rtCGM) vs blood glucose metre (BGM)) and diabetes distress (DD) in adults with type 1 diabetes (T1D)., Research Design and Methods: We combined data from two Danish questionnaire-based surveys, the Steno Tech Survey (n=1591) and the Type 1 Diabetes Distress Scale (T1-DDS) validation survey (n=4205), in which individuals aged ≥18 years with T1D were invited to participate. The 28-item T1-DDS was used to measure DD and DD scores were categorised as little or no distress (score <2.0), moderate distress (2.0-2.9) and high distress (score ≥3.0). Associations between insulin delivery, glucose monitoring methods and DD were assessed using linear regression., Results: Among 2068 adults with T1D who responded to one of the surveys, the use of IPT was associated with a lower total T1-DDS score (-0.09, 95% CI 0.16 to -0.03) compared with MDI and adjusted for glucose monitoring method. The use of CGM was associated with a higher total T1-DDS score (0.11, 95% CI 0.05 to 0.18) compared with BGM and adjusted for the insulin delivery method. IPT was still associated with a lower T1-DDS score, regardless of being combined with BGM (-0.17, 95% CI -0.28 to -0.06) or CGM (-0.13, 95% CI -0.21 to -0.05), compared with MDI with CGM. No association was found between the type of CGM (isCGM vs rtCGM) and DD among either IPT or MDI users when restricting analysis to individuals using CGM., Conclusions: Among Danish adults with T1D, the use of IPT was associated with lower levels of DD, while CGM use was associated with higher levels of DD. DD should be addressed when introducing people with T1D to diabetes technology, CGM in particular., Trial Registration Number: NCT04311164 (Results)., Competing Interests: Competing interests: JTL and KPM own shares in Novo Nordisk. KN own shares in Novo Nordisk, has been a paid consultant for Novo Nordisk and Medtronic, has received speaker’s honorarium and honorarium for Advisory Board to her institution from Medtronic, Novo Nordisk, Convatec and Pharmasens and her institution has received funding from Zealand Pharma, Novo Nordisk, Medtronic and Dexcom. UPB has served on advisory boards for Novo Nordisk, Sanofi and Vertex and has received lecture fees from Novo Nordisk and Sanofi. SS has worked for Novo Nordisk between May 2022 and April 2023 and has received speaker’s honorarium from Novo Nordisk. KR own shares in Novo Nordisk and has received speaker’s honorarium from Medtronic., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Diabetic ketoacidosis (DKA) is a life-threatening but preventable complication in people with type 1 diabetes. We aimed to quantify the incidence of DKA according to age and describe the time trend of DKA among adults with type 1 diabetes in Denmark., Research Design and Methods: Individuals aged ≥18 years with type 1 diabetes were identified from a nationwide Danish diabetes register. Hospital admissions due to DKA were ascertained from the National Patient Register. The follow-up period was from 1996 to 2020., Results: The cohort consisted of 24,718 adults with type 1 diabetes. The incidence rate of DKA per 100 person-years (PY) decreased with increasing age for both men and women. From 20 to 80 years of age, the DKA incidence rate decreased from 3.27 to 0.38 per 100 PY. From 1996 to 2008, the incidence rate of DKA increased for all age-groups, with a subsequent minor decrease in incidence rate until 2020. From 1996 to 2008, the incidence rates increased from 1.91 to 3.77 per 100 PY for a 20-year-old individual and from 0.22 to 0.44 per 100 PY for an 80-year-old individual living with type 1 diabetes. From 2008 to 2020 the incidence rates decreased from 3.77 to 3.27 and from 0.44 to 0.38 per 100 PY, respectively., Conclusions: The incidence rates of DKA are declining for all ages, with an overall decline from 2008 for both men and women. This likely reflects improved diabetes management for individuals with type 1 diabetes in Denmark., (© 2023 by the American Diabetes Association.)

Introduction: Patients receiving haemodialysis are at increased risk of arrhythmias and sudden cardiac death, but data on arrhythmia burden and the pathophysiology remain limited. Among potential risk factors, hypoglycaemia is proposed as a possible trigger of lethal arrhythmias. The development of implantable loop recorders (ILR) and continuous glucose monitoring (CGM) enables long-term continuous ECG and glycaemic monitoring. The current article presents the protocol of a study aiming to increase the understanding of arrhythmias and risk factors in patients receiving haemodialysis. The findings will provide a detailed exploration of the burden and nature of arrhythmias in these patients including the potential association between hypoglycaemia and arrhythmias., Methods and Analysis: The study is an investigator-initiated, prospective, multicentre cohort study recruiting 70 patients receiving haemodialysis: 35 with diabetes and 35 without diabetes. Participants are monitored with ILRs and CGM for 18 months follow-up. Data collection further includes a monthly collection of predialysis blood samples and dialysis parameters. The primary outcome is the presence of clinically significant arrhythmias defined as a composite of bradycardia, ventricular tachycardia, or ventricular fibrillation. Secondary outcomes include the characterisation of clinically significant arrhythmias and other arrhythmias, glycaemic characteristics, and mortality. The data analyses include an assessment of the association between arrhythmias and hypoglycaemia and hyperglycaemia, baseline clinical variables, and parameters related to kidney failure and the haemodialysis procedure., Ethics and Dissemination: The study has been approved by the Ethics Committee of the Capital Region of Denmark (H-20069767). The findings will be presented at national and international congresses as well as in international peer-reviewed scientific journals., Trial Registration Number: NCT04841304., Competing Interests: Competing interests: DHK has received speaker honoraria from Bayer A/S outside the submitted work. SZD is a consultant to Cortrium and Vital Beats and a member of Bristol Myers Squibb/Pfizer advisory board and has received speaker honoraria from Bristol Myers Squibb/Pfizer and Bayer. TB is a member of Medtronic and AstraZeneca advisory board and has received speaker honoraria from AstraZeneca outside the submitted work. ML is a member of advisory board at AstraZeneca, Bayer A/S Denmark, Boehringer Ingelheim, GlaxoSmithKline and received speaker honoraria from AstraZeneca, Bayer A/S Denmark and Boehringer Ingelheim. KN holds stocks in Novo Nordisk; has been a paid consultant for Novo Nordisk and Medtronic; has received speaker honorarium and honorarium for Advisory Board to her institution from Medtronic, Novo Nordisk, Convatec, and her institution has received research funding from Zealand Pharma, Novo Nordisk, Medtronic and Dexcom. TPA holds stocks in Novo Nordisk A/S. JHS is a member of Medtronic advisory board and has received speaker honoraria and research grants from Medtronic outside the submitted work. MH has served on scientific advisory boards for the following companies outside the scope of this study: Astra Zeneca A/S, Boehringer Ingelheim A/S, GSK A/S and CSL Vifor Pharma A/S; has served as moderator of a symposium and an educational meeting for Astra Zeneca A/S; has received research grants from the A.P. Møller Foundation, Augustinus Foundation, Helen Bjørnow Foundation, Lundbeck Foundation and has a Twinning Horizon Europe Grant. All other authors have no conflicts of interest to declare., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Transmission of obesity across generations is of concern. Offspring of obese women have short- and long-term increased morbidities. A high intake of carbohydrate during pregnancy combined with impaired glucose tolerance is postulated to result in high birth weight, which is linked to subsequent metabolic disease., Objective: The objective was to examine the association between carbohydrate intake in obese pregnant women and their offspring's body composition., Design: Secondary analyses were performed in an observational setting of 222 pregnant women with a pregestational BMI (in kg/m(2)) ≥30 participating in a randomized controlled trial. Diet was assessed at gestational weeks 11-14 and 36-37 by using a semiquantitative food-frequency questionnaire. Body composition in the offspring was assessed at birth by dual-energy X-ray absorptiometry. Relative fat mass (%) was the primary outcome. Absolute measures (total fat, abdominal fat, and lean body mass) were secondary outcomes., Results: Mean ± SD weight and absolute and relative fat mass in the offspring at birth were 3769 ± 542 g, 436 ± 214 g, and 11% ± 4%, respectively. Maternal intake of digestible carbohydrates was associated with the offspring's relative fat mass in late (P-trend = 0.006) but not early (P-trend = 0.15) pregnancy. A comparison of mothers in the highest (median: 238 g/d) compared with the lowest (median: 188 g/d) quartile of digestible carbohydrate intake showed a mean adjusted higher value in the offspring's relative fat mass of 2.1% (95% CI: 0.6%, 3.7%), which corresponded in absolute terms to a 103-g (95% CI: 27, 179-g) higher fat mass. Abdominal fat mass was also higher. In a strata of women with well-controlled glucose (2-h glucose values ≤6.6 mmol/L), no association between carbohydrate intake and offspring fat mass was observed, but the associations became significant and increased in strength with higher intolerance (strata with 2-h glucose values between 6.7-7.7 and ≥7.8 mmol/L)., Conclusion: In obese women, even those without gestational diabetes but with impaired glucose tolerance, a lower carbohydrate intake at moderate levels in late gestation is associated with a lower fat mass in their offspring at birth. The TOP study was registered at clinicaltrials.gov as NCT01345149., (© 2015 American Society for Nutrition.)

Objective: To examine the representativeness of participants attending a lifestyle intervention study addressing obese pregnant women., Methods: Retrospective comparison of baseline data, attendance to oral glucose tolerance test (OGTT) during pregnancy, and pregnancy outcome in eligible women stratified according to study participation. Of 750 eligible women with a self-reported BMI > 30 kg/m(2), and a live singleton pregnancy, 510 were eligible for inclusion and 425 were randomized to either active intervention (n= 284) or to standard obstetric care (n= 141) including two standard OGTT. The 85 women who declined participation or were excluded due to competing diseases and 240 women who did not respond to the initial invitation received the same standard care., Results: The randomized women had similar BMI but a lower parity and age, and were more frequently non-smokers, born in Denmark and married or cohabitating with their partner than the non-participants. Women participating in the trial had a higher compliance to the second OGTT compared to non-participants, also after correcting for age and nationality. There was no difference in pregnancy outcome, i.e., fetal weight and length, gestational age as well as mode of delivery., Conclusion: Women declining participation in a randomized lifestyle intervention study in pregnancy have characteristics indicating they are those who might benefit the most from lifestyle intervention.

Introduction: Assessment of physicians' performance focuses on the quality of their work. The aim of this study was to develop a valid, usable and acceptable multisource feedback assessment tool (MFAT) for hospital consultants., Material and Methods: Statements were produced on consultant competencies within non-medical areas like collaboration, professionalism, communication, health promotion, academics and administration. The statements were validated by physicians and later by non-physician professionals after adjustments had been made. In a pilot test, a group of consultants was assessed using the final collection of statements of the MFAT. They received a report with their personal results and subsequently evaluated the assessment method., Results: In total, 66 statements were developed and after validation they were reduced and reformulated to 35. Mean scores for relevance and "easy to understand" of the statements were in the range between "very high degree" and "high degree". In the pilot test, 18 consultants were assessed by themselves, by 141 other physicians and by 125 other professionals in the hospital. About two thirds greatly benefited of the assessment report and half identified areas for personal development. About a third did not want the head of their department to know the assessment results directly; however, two thirds found a potential value in discussing the results with the head., Conclusion: We developed an MFAT for consultants with relevant and understandable statements. A pilot test confirmed that most of the consultants gained from the assessment, but some did not like to share their results with their heads. For these specialists other methods should be used.

Introduction: Diabetes passports for patients have been used for years in hospitals in our region. Since 2004 data have been printed from the electronic database DiabetesRASK and a new edition of the passport is given to patients at each visit. One of the objectives of the passport is to serve as a pedagogic tool. However, patients' understanding and use of the passport has never been studied., Materials and Methods: Inclusion criteria for patients: type 2 diabetes, born in Turkey (T) or Pakistan (P), regular attendees at the outpatient clinics at Hvidovre Hospital or Amager Hospital and their personal diabetes data in the database DiabetesRASK. A comparable group of Danish diabetes patients was selected. All were invited to participate in a semi-structured interview., Results: 14 T, 11 P and 10 D patients participated in the study. 53% T and 73% P had the ability to read in their own language while 15% T and 55% P were able to read in Danish. In the groups fewer than 25% had ever shown their passport to the GP. Between 0% and 36% of any of the given questions were understood or identified correctly by T patients. Similar figures for the P and D patients were 0-55% and 30-100%., Conclusion: It is demonstrated that the diabetes passport is not widely used by patients. Furthermore, we found poor understanding of information on the passport in general but with great individual variability. The poorest understanding was found among immigrants, which might be the result of language problems. However, Danish patients also had insufficient understanding of the information. We recommend that the diabetes passport be rewritten so that it is more easily understood by patients and that outpatient clinics also allocate more resources to the guidance of patients concerning the passport.