Metabolic effect of adrenaline infusion in people with type 1 diabetes and healthy individuals.

AIMS/HYPOTHESIS: As a result of early loss of the glucagon response, adrenaline is the primary counter-regulatory hormone in type 1 diabetes. Diminished adrenaline responses to hypoglycaemia due to counter-regulatory failure are common in type 1 diabetes, and are probably induced by exposure to recurrent hypoglycaemia, however, the metabolic effects of adrenaline have received less research attention, and also there is conflicting evidence regarding adrenaline sensitivity in type 1 diabetes. Thus, we aimed to investigate the metabolic response to adrenaline and explore whether it is modified by prior exposure to hypoglycaemia. METHODS: Eighteen participants with type 1 diabetes and nine healthy participants underwent a three-step ascending adrenaline infusion during a hyperinsulinaemic-euglycaemic clamp. Continuous glucose monitoring data obtained during the week before the study day were used to assess the extent of hypoglycaemia exposure. RESULTS: While glucose responses during the clamp were similar between people with type 1 diabetes and healthy participants, plasma concentrations of NEFAs and glycerol only increased in the group with type 1 diabetes (p<0.001). Metabolomics revealed an increase in the most common NEFAs (p<0.01). Other metabolic responses were generally similar between participants with type 1 diabetes and healthy participants. Exposure to hypoglycaemia was negatively associated with the NEFA response; however, this was not statistically significant. CONCLUSIONS/INTERPRETATION: In conclusion, individuals with type 1 diabetes respond with increased lipolysis to adrenaline compared with healthy participants by mobilising the abundant NEFAs in plasma, whereas other metabolic responses were similar. This may suggest that the metabolic sensitivity to adrenaline is altered in a pathway-specific manner in type 1 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05095259.

Associations between insulin pump self-management and HbA1c in type 1 diabetes.

AIMS: Insulin pump self-management is important for glycaemic outcomes. We aimed to investigate associations between self-management factors and HbA1c. METHODS: Adult insulin pump users with type 1 diabetes (n = 770) completed an online questionnaire. The latest HbA1c and demographics were extracted from national registries. Associations between HbA1c and self-management (use of advanced features, timing of infusion set change, timing of meal bolus, data-upload and pump settings adjustments) were investigated using backward selected linear regression models. RESULTS: Of the 699 responders eligible for this study, 60% were women; the median age and diabetes duration were 49 and 25 years, respectively. Significant associations with HbA1c were found for changing infusion set every 0-4 days relative to 5-10 days (-5 mmol/mol (-0.4%), p = 0.003), and for never/rarely missing a bolus (-6 mmol/mol (-0.5%), p < 0.001) relative to often missing a bolus. Timing insulin 10-15 min before meal relative to after meal start was also associated with lower HbA1c (-3 mmol/mol (-0.3%), p = 0.023). Self-adjusting pump settings showed the strongest association with lower HbA1c (-6 mmol/mol (-0.6%), p < 0.001) relative to health care professionals doing all adjustments. CONCLUSION: Self-adjusting insulin pump settings, optimal timing and few omissions of meal boluses, and timely change of infusion set are associated with lower HbA1c.

Isolated thoughts and feelings and unsolved concerns: adolescents' and parents' perspectives on living with type 1 diabetes - a qualitative study using visual storytelling.

AIMS AND OBJECTIVES: To explore and describe the experiences of adolescents and their parents living with type 1 diabetes, to identify their needs for support to improve adolescents' self-management skills in the transition from child- to adulthood. BACKGROUND: Adolescents with type 1 diabetes often experience deteriorating glycaemic control and distress. Parents are important in adolescents' ability to self-manage type 1 diabetes, but they report anxiety and frustrations. A better understanding of the challenges adolescents and parents face, in relation to the daily self-management of type 1 diabetes, is important to improve clinical practice. DESIGN: A qualitative explorative study using visual storytelling as part of individual interviews. METHODS: A purposive sample of nine adolescents and their parents (seven mothers, six fathers) took photographs illustrating their experiences living with type 1 diabetes. Subsequently, participants were interviewed individually guided by participants' photographs and a semistructured interview guide. Interviews were analysed using thematic analysis. RESULTS: Four major themes were consistent across adolescents and their parents: (1) striving for safety, (2) striving for normality, (3) striving for independence and (4) worrying about future. Although adolescents and parents had same concerns and challenges living with type 1 diabetes, they were experienced differently. Their thoughts and feelings mostly remained isolated and their concerns and challenges unsolved. CONCLUSIONS: The concerns and challenges adolescents and their parents face in the transition from child- to adulthood are still present despite new treatment modalities. Parents are fundamental in supporting the adolescents' self-management-work; however, the parties have unspoken concerns and challenges. RELEVANCE TO CLINICAL PRACTICE: Healthcare providers should address the parties' challenges and concerns living with type 1 diabetes to diminish worries about future including fear of hypoglycaemia, the burden of type 1 diabetes and the feeling of being incompetent in diabetes self-management. It is important to focus on supporting both adolescents and their parents, and to provide a shared platform for communication.

Adolescents developing life skills for managing type 1 diabetes: a qualitative, realistic evaluation of a guided self-determination-youth intervention.

AIM: To explore and illustrate how the Guided Self-Determination-Youth method influences the development of life skills in adolescents with type 1 diabetes supported by their parents and healthcare providers. BACKGROUND: Evidence-based methods that accomplish constructive cooperation between adolescents with poorly controlled type 1 diabetes, their parents and healthcare providers are needed. We adjusted an adult life skills intervention comprising reflection sheets and advanced communication for use by adolescent-parent-professional triads in outpatient visits. DESIGN: A qualitative realistic evaluation design comprising eight context-mechanism-outcome configurations directed the analysis of the Guided Self-Determination-Youth's influence on adolescent-parent-professional triads to evaluate what worked for whom, how and in what circumstances. Thirteen adolescents aged 13-18 years diagnosed with type 1 diabetes for ≥1 year and having poor glycaemic control participated together with 17 parents and eight healthcare providers. Data were collected from December 2009-March 2012 and consisted of digitally recorded outpatient Guide Self-Determination-Youth visits collected during the intervention period (11·5-24·5 months) and semi-structured interviews at 6-month follow-up. FINDINGS: Emerging life skills in adolescents were identified as: (1) developing new relatedness with healthcare providers and parents; (2) becoming decision makers in their own lives with diabetes; and (3) growing personally. Reflection sheets combined with healthcare providers' advanced communication were central to promoting mutual problem-solving. CONCLUSION: A life skills approach turned outpatient visits into person-specific visits with improved cooperation patterns in the triads. Combining reflection sheets and advanced communication skills supported adolescents in beginning a process of developing life skills.

Associations between clinical and psychosocial factors and HbA1c in adult insulin pump users with type 1 diabetes.

AIMS: Many adults with type 1 diabetes do not achieve recommended glycemic goals despite intensive insulin therapy using insulin pumps. The aim of this study was to explore associations between clinical and psychosocial factors and HbA1c in insulin pump users to identify and prioritize areas for potential intervention. METHODS: A questionnaire-based survey covering clinical and psychosocial aspects of life with type 1 diabetes was distributed to all adult (≥ 18 years) insulin pump users in the Capital Region of Denmark. Responses were combined with data from medical records and national registries. Associations with HbA1c were modeled using regression-based machine learning. RESULTS: Of 1,591 invited individuals, 770 (48.4%) responded to the survey. Mean HbA1c among responders was 7.3% (56 mmol/mmol), and 35.6% had an HbA1c < 7.0% (53 mmol/mol). Six factors were significantly associated with HbA1c: diabetes duration (0.006% (0.1 mmol/mol) lower HbA1c per 1-year increase in diabetes duration); education (0.4% (4.3 mmol/mol) lower HbA1c with long higher education vs. primary school); insulin type (0.2% (2.2 mmol/mol) lower HbA1c with ultra-rapid-acting insulin vs. rapid-acting insulin); hypoglycemia awareness status (0.2% (2.2 mmol/mol) lower HbA1c with complete unawareness vs. full awareness); insulin device satisfaction (0.2% (2.7 mmol/mol) lower HbA1c per 1-point increase in Insulin Device Satisfaction Survey score); and diabetes distress (0.3% (3.1 mmol/mol) higher HbA1c per 1-point increase in Type 1 Diabetes Distress Scale score). CONCLUSIONS: This study identified several associations between clinical and psychosocial factors and HbA1c that may be considered when developing interventions targeted people with type 1 diabetes.

Glycemic Effects and Predictors of Increased Time-in-Range After Initiating MiniMed 670G: A 12-Month Observational Study.

We aimed to evaluate the glycemic effect and detect any predictors of improved time-in-range (TIR) in persons with type 1 diabetes after initiating hybrid closed-loop (HCL) treatment with MiniMed 670G in a 12-month retrospective observational study. Before starting HCL treatment, the 62 participants followed a Steno-developed training program; 7 participants (6.5%) discontinued the HCL therapy; the remaining 55 (58% female) had an age (mean ± standard deviation) of 45.6 ± 12.6 years and diabetes duration of 28.2 ± 10.9 years. After 12 months' HCL therapy, glycated hemoglobin A1c decreased from 7.4% +0.7% to 7.1% +0.5%, TIR increased from 59.3% ± 13.5% to 72% ± 9.3%, time in 54-70 mg/dL (3.0-3.9 mM) decreased from 2.4% ± 2.0% to 1.4% ± 1.0%, and time in 180-250 mg/dL (10.0-13.9 mM) decreased from 26.4% ± 8.3% to 20.8% ± 5.5%, all P < 0.001. Improvement in TIR was significantly associated with lower total daily insulin dose, higher amount of total carbohydrate, and more time spent in Auto Mode. Our findings support the promising results on glycemic outcomes seen with HCL treatment.

Advanced glycation end-products are associated with diabetic neuropathy in young adults with type 1 diabetes.

Aims/hypothesis: Advanced glycation end-products (AGEs) may contribute to the development of diabetic neuropathy. In young adults with type 1 diabetes, we aimed to investigate the association between AGEs and cardiovascular autonomic neuropathy (CAN) and distal symmetric polyneuropathy (DSPN). Methods: This cross-sectional study comprised 151 young adults. CAN was assessed by cardiovascular autonomic reflex tests; lying-to-standing test, deep breathing test (E/I), Valsalva manoeuvre, and heart rate variability indices; and the mean square of the sum of the squares of differences between consecutive R-R intervals and standard deviation of normal-to-normal intervals (SDNN), high- (HF) and low-frequency (LF) power, total frequency power, and the LF/HF ratio. DSPN was assessed by light touch, pain and vibration perception threshold (VPT), neuropathy questionnaires, and objective measures. AGEs were analysed in four groups using z-scores adjusted for relevant confounders and multiple testing: i) "glycolytic dysfunction", ii) "lipid peroxidation", iii) "oxidative stress", and iv) "glucotoxicity". Results: A higher z-score of "glycolytic dysfunction" was associated with higher VPT (4.14% (95% CI 1.31; 7.04), p = 0.004) and E/I (0.03% (95% CI 0.01; 0.05), p = 0.005), "lipid peroxidation" was associated with higher LF/HF ratio (37.72% (95% CI 1.12; 87.57), p = 0.044), and "glucotoxicity" was associated with lower SDNN (-4.20% (95% CI -8.1416; -0.0896), p = 0.047). No significance remained after adjustment for multiple testing. Conclusions/interpretations: In young adults with type 1 diabetes, increased levels of AGEs involving different metabolic pathways were associated with several measures of CAN and DSPN, suggesting that AGEs may play a diverse role in the pathogeneses of diabetic neuropathy.

Insulin Pump Treatment in Adults with Type 1 Diabetes in the Capital Region of Denmark: Design and Cohort Characteristics of the Steno Tech Survey.

INTRODUCTION: Insulin pump therapy can improve quality of life and glycaemic outcomes for many people with type 1 diabetes (T1D). The multidimensional Steno Tech Survey study aims to investigate why some insulin pump users do not achieve treatment goals. In this article, we present the study design and analyse differences in population characteristics between responders and non-responders. METHODS: In June 2020, all 1591 insulin pump users (≥ 18 years) in the Capital Region of Denmark were invited to participate in an online questionnaire that evaluated several dimensions of insulin pump self-management and psychosocial health. Demographic, socioeconomic and clinical characteristics, including age, sex and HbA1c, of the cohort were identified via national registries. Predictors of questionnaire response/non-response were explored with logistic regression analysis. RESULTS: In the full study population, 58% were female, median age was 42 years and median HbA1c was 58 mmol/mol (7.5%); 30% had HbA1c < 53 mmol/mol (7.0%). In total, 770 individuals (48%) responded to the questionnaire. Logistic regression analysis showed that 50+ years of age (odds ratio [OR] = 2.3, 95% confidence interval [CI]: 1.4-3.8), female sex (OR = 1.3, CI: 1.02-1.6), being married (OR = 1.8, CI: 1.3-2.4) and having long higher education (OR = 1.6, CI: 1.004-2.5) were significantly associated with a higher likelihood of responding to the survey; the opposite was found for HbA1c from 64 to < 75 mmol (8.0-9.0%) (OR = 0.6, CI: 0.4-0.8) and HbA1c ≥ 75 mmol/mol (≥ 9.0%) (OR = 0.2, CI: 0.1-0.3). CONCLUSIONS: The established Steno Tech cohort enables future analysis of a range of psychosocial and behavioural aspects of insulin pump self-management. Interpretation and generalization of findings should consider observed differences between responders and non-responders.

Improving glycaemic control and life skills in adolescents with type 1 diabetes: a randomised, controlled intervention study using the Guided Self-Determination-Young method in triads of adolescents, parents and health care providers integrated into routine paediatric outpatient clinics.

BACKGROUND: Adolescents with type 1 diabetes face demanding challenges due to conflicting priorities between psychosocial needs and diabetes management. This conflict often results in poor glycaemic control and discord between adolescents and parents. Adolescent-parent conflicts are thus a barrier for health care providers (HCPs) to overcome in their attempts to involve both adolescents and parents in improvement of glycaemic control. Evidence-based interventions that involve all three parties (i.e., adolescents, parents and HCPs) and are integrated into routine outpatient clinic visits are lacking. The Guided Self-Determination method is proven effective in adult care and has been adapted to adolescents and parents (Guided Self-Determination-Young (GSD-Y)) for use in paediatric diabetes outpatient clinics. Our objective is to test whether GSD-Y used in routine paediatric outpatient clinic visits will reduce haemoglobin A1c (HbA1c) concentrations and improve adolescents' life skills compared with a control group. METHODS/DESIGN: Using a mixed methods design comprising a randomised controlled trial and a nested qualitative evaluation, we will recruit 68 adolescents age 13-18 years with type 1 diabetes (HbA1c > 8.0%) and their parents from 2 Danish hospitals and randomise into GSD-Y or control groups. During an 8-12 month period, the GSD-Y group will complete 8 outpatient GSD-Y visits, and the control group will completes an equal number of standard visits. The primary outcome is HbA1c. Secondary outcomes include the following: number of self-monitored blood glucose values and levels of autonomous motivation, involvement and autonomy support from parents, autonomy support from HCPs, perceived competence in managing diabetes, well-being, and diabetes-related problems. Primary and secondary outcomes will be evaluated within and between groups by comparing data from baseline, after completion of the visits, and again after a 6-month follow-up. To illustrate how GSD-Y influences glycaemic control and the development of life skills, 10-12 GSD-Y visits will be recorded during the intervention and analysed qualitatively together with individual interviews carried out after follow-up. DISCUSSION: This study will provide evidence of the effectiveness of using a GSD-Y intervention with three parties on HbA1c and life skills and the feasibility of integrating the intervention into routine outpatient clinic visits. Danish Data Association ref nr. 2008-41-2322. TRIAL REGISTRATION: ISRCTN54243636.

Efficacy of Bolus Calculation and Advanced Carbohydrate Counting in Type 2 Diabetes: A Randomized Clinical Trial.

Background: Carbohydrate counting and use of automated bolus calculators (ABCs) can help reduce HbA1c in type 1 diabetes but only limited evidence exists in type 2 diabetes. We evaluated the efficacy of advanced carbohydrate counting (ACC) and use of an ABC compared with manual insulin bolus calculation (MC) in persons with type 2 diabetes. Materials and Methods: A 24-week open-label, randomized clinical study was conducted in 79 persons with type 2 diabetes treated with basal-bolus insulin (mean age 62.5 ± 9.6 years, HbA1c 8.7% ± 1.0% [72 ± 11 mmol/mol], diabetes duration 18.7 ± 7.6 years). Participants were randomized 1:1 into two groups: ABC group received training in ACC and use of an ABC; MC group received training in ACC and manual calculation of insulin bolus. Participants wore blinded continuous glucose monitors for 6 days at baseline and at study end. Primary endpoint was change in HbA1c. Results: After 24 weeks, HbA1c decreased 0.8% (8.8 mmol/mol) in ABC group and 0.8% (9.0 mmol/mol) in MC group with no between-group difference (P = 0.96) and without increase in time in hypoglycemic range (sensor glucose <3.9 mmol/L). Glycemic variability decreased significantly in both groups, whereas the total insulin dose and body mass index (BMI) remained unchanged during the study. Treatment satisfaction increased significantly in both groups after 24 weeks. Conclusion: ACC is an effective, low-cost tool to reduce HbA1c and glycemic variability in persons with basal-bolus insulin-treated type 2 diabetes without increase in hypoglycemia or BMI. Similar effects were seen with use of an ABC and with use of manual bolus calculation. Trial registration: ClinicalTrials.gov NCT02887898.

Glycemic Variability and Diabetic Neuropathy in Young Adults With Type 1 Diabetes.

Background: Glycemic variability (GV) may attribute to the pathogenesis of diabetic neuropathy. The aim of this cross-sectional study was to investigate the association between GV and distal symmetric polyneuropathy (DSPN) and cardiovascular autonomic neuropathy (CAN) in a Danish population of young adults with type 1 diabetes. Methods: Young adults between 18 and 24 years with type 1 diabetes were included in this cross-sectional study. CAN was assessed by cardiovascular autonomic reflex tests (CARTs) and heart rate variability (HRV). DSPN was assessed by light pressure, pain and vibration perception, electrochemical skin conductance, sural nerve conduction velocity (SNCV), and amplitude potential (SNAP). GV were obtained by continuous glucose monitoring including coefficient of variation (CV), SD, continuous overall net glycemic action (CONGA), and mean amplitude of glucose excursions (MAGE). Results: The study comprised 133 young adults (43.6% males), mean age of 22 years (SD 1.6). Unadjusted, higher CV was associated with a decreased risk of sural nerve conduction (P = 0.03), abnormal SNAP (P = 0.04) and incidents of definite CAN (P = 0.04). Likewise, higher CONGA was associated with increasing incidents of subclinical DSPN (P = 0.03), abnormal SNAP (P = 0.01), and SNCV (P = 0.02). However, both associations were not statistically significant in the fully adjusted model. Higher MAGE was associated with slightly increasing measures of HRV (P = 0.03) but only when fully adjusted. When correcting for multiple tests significance was lost. A significant association was found between HbA1c and measures of both DSPN (P < 0.02) and HRV (P < 0.03) in fully adjusted models. Conclusions: No significant associations between GV and diabetic neuropathy were found after adjusting for risk factors and multiple tests. This suggests that GV may not be a risk factor for diabetic neuropathy in young adults with type 1 diabetes. However, long-term effects of GV excursions may still play a role in the pathogenic mechanisms leading to neuropathy in later life.

Skin Problems Due to Treatment with Technology Are Associated with Increased Disease Burden Among Adults with Type 1 Diabetes.

BACKGROUND: In a 4-month follow-up survey, we examined whether treatment with continuous subcutaneous insulin infusion (CSII) and/or continuous glucose monitoring (CGM) in adults with type 1 diabetes was associated with sustained skin problems and whether skin problems were associated with diabetes-related emotional distress. RESEARCH DESIGN AND METHODS: A total of 111 adult patients completed a follow-up questionnaire concerning skin problems as a result of CSII and/or CGM use. The questionnaire included a patient-reported outcome measure, the Problem Areas in Diabetes (PAID) scale. RESULTS: Current visible skin problems caused by CSII or CGM use were reported by 51 (46.0%) participants, in 34 (66.7%) of whom skin problems had been reported more than 4 months earlier. Seventy-two (64.9%) participants reported skin problems as a result of CSII use, whereas 38 (74.5%) reported skin problems owing to CGM use at some time. Itching was the most prevalent complaint. CSII-related itching was associated with a mean PAID score >20 (P = 0.01), and patients with more than one skin problem had an increased PAID score compared with those with one or no skin problems (P = 0.006). CONCLUSIONS: More than half patients treated with CSII, CGM, or both had experienced skin problems during 4 months of follow-up that were associated with increased diabetes burden. Skin problems represent a persistent health issue affecting diabetes-specific emotional distress.

Prevalence of Diabetic Neuropathy in Young Adults with Type 1 Diabetes and the Association with Insulin Pump Therapy.

AIMS: The aim was to investigate the prevalence of diabetic sensorimotor polyneuropathy (DSPN) and cardiovascular autonomic neuropathy (CAN) in a Danish population of young adults with type 1 diabetes (T1D) using both established and novel measuring modalities. Furthermore, to investigate the association between continuous subcutaneous insulin infusion (CSII) treatment and these complications. MATERIALS AND METHODS: CAN was assessed by cardiovascular autonomic reflex tests. DSPN was assessed not only by perception of light touch and pain, vibration perception threshold (VPT), Brief Pain Inventory (BPI), and Michigan Neuropathy Screening Instrument questionnaires but also by novel modalities: electrochemical skin conductance (ESC), sural nerve conduction velocity (SNCV), and sural nerve amplitude potential (SNAP). RESULTS: The study comprised 156 young adults with a mean age of 22 years (standard deviation 1.6). The prevalence of CAN and early CAN was 9% and 28.1%, respectively. Subclinical DSPN was 55.1% and confirmed DSPN was 2.6%. Prevalence of abnormal SNAP was 23.8%, SNCV was 37.1%, ESC on the hands and feet was 4% and 8%, respectively, VPT was 1.3%, and BPI questionnaire was 1.9%. No association was found between CSII treatment and the measures of DSPN and CAN. CONCLUSION: DSPN and CAN are prevalent in young adults with T1D with no association found with CSII treatment. The use of novel measuring modalities identified a higher number of subjects with DSPN compared with established measures. Screening for diabetic neuropathy in young adults may be beneficial to detect and prevent nerve damages at early stages.

Skin Problems Associated with Insulin Pumps and Sensors in Adults with Type 1 Diabetes: A Cross-Sectional Study.

BACKGROUND: In the future, widespread use of closed-loop infusion (artificial pancreas) systems to treat type 1 diabetes (T1D) may significantly improve glycemic control and enhance treatment flexibility. However, the infusion sets and plasters necessary for these treatments can cause dermatological complications that may hamper the spread of the new technology; few studies have investigated these complications in adults. The aim of this study was to describe the dermatological complications associated with continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) in adults. METHODS: A total of 118 adult patients from two different diabetes clinics completed a questionnaire concerning the dermatological complications associated with their CSII and/or CGM treatment, other treatment variables, duration of diabetes, allergies, skin care, and other pathologies. RESULTS: CGM or CSII use was associated with current eczema, scars, and wounds. In total, 34% of CSII users and 35% of CGM users currently had one or more skin lesions due to the use of these devices. We found no significant association with glycated hemoglobin (HbA1c) levels, a history of atopic dermatitis, or other skin pathologies. However, multivariate analysis revealed associations with a history of atopy and CSII-associated dermatological complications. CONCLUSIONS: Dermatological complications were present in one in every three patients and represent a significant challenge to using CSII and CGM to treat adults with T1D. Prospective studies on the causes of these complications will be required to develop preventive strategies and ensure that optimal diabetes treatment approaches that take advantage of the latest technology can be implemented.

Testing a Smartphone App (Young with Diabetes) to Improve Self-Management of Diabetes Over 12 Months: Randomized Controlled Trial.

BACKGROUND: Young people often struggle to self-manage type 1 diabetes during the transition from childhood to adulthood. Mobile health (mHealth) apps may have the potential to support self-management, but evidence is limited and randomized controlled trials are needed. OBJECTIVE: We assessed whether the mHealth app "Young with Diabetes" improved young people's self-management measured by glycated hemoglobin (HbA1c) and three self-reported psychometric scales. METHODS: Young people (14-22 years) with inadequate glycemic control and their parents were enrolled in a randomized controlled trial and assigned either to Young with Diabetes and usual care (Young with Diabetes group) or to usual care alone (control). Young with Diabetes use was monitored; functions included a chat room, contact the health care provider, reminders, tips, information about the diabetes department and type 1 diabetes topics, carbohydrate counting, and a parents' section. Outcomes included HbA1c and three self-reported psychometric scales: Perceived Competence in Diabetes Scale; Health Care Climate Questionnaire; and Problem Areas In Diabetes care survey. Data were collected at baseline and at 2, 7, and 12 months. RESULTS: A total of 151 young people were randomized (Young with Diabetes group=76, control=75) and 49 parents agreed to participate. At 12 months, HbA1c was significantly higher (4.1 mmol/mol; 0.4 %) in the Young with Diabetes group, compared to the control group (P=.04); this finding did not occur when comparing app users (Young with Diabetes use ≥5 days) with nonusers. Young people used Young with Diabetes on a mean of 10.5 days. They spent the most time chatting about alcohol and searching for information about sex. Most young people and half of the parents reported that Young with Diabetes helped them. More than 80% would recommend Young with Diabetes to peers. CONCLUSIONS: Young with Diabetes did not improve HbA1c, but it may be a useful complement to self-management. Qualitative evaluation is needed to explore benefits and shortcomings of Young with Diabetes. Health care providers should address young peoples' knowledge about sensitive topics, provide them with peer support, and be aware of parents' need for information about how to support. TRIAL REGISTRATION: ClinicalTrials.gov NCT02632383; https://clinicaltrials.gov/ct2/show/NCT02632383 (Archived by WebCite at http://www.webcitation.org/6zCK2u7xM).

Use of intensified comprehensive cardiac rehabilitation to improve risk factor control in patients with type 2 diabetes mellitus or impaired glucose tolerance--the randomized DANish StUdy of impaired glucose metabolism in the settings of cardiac rehabilitation (DANSUK) study.

BACKGROUND: The DANish StUdy of impaired glucose metabolism in the settings of cardiac rehabilitation (DANSUK) examined the effect of an intensified multifactorial intervention on risk factor profile in 104 patients with type 2 diabetes mellitus (T2DM) or impaired glucose tolerance (IGT) attending hospital-based outpatient comprehensive cardiac rehabilitation (CCR) compared to usual care (UC). METHODS: Patients with ischemic heart disease (67%), congestive heart failure (7%), or at least 3 risk factors for ischemic heart disease (26%) discharged from 1 coronary care unit were referred to CCR. Of 473 eligible individuals, 201 agreed to participate in the study, and 52% had T2DM or IGT. Patients randomized to CCR received a stepwise implementation of behavioral modification and pharmacotherapy. RESULTS: After 1 year, patients with T2DM in the CCR group experienced a mean change in HbA1c of -0.65% +/- 0.9% compared with a mean change of -0.08% +/- 0.7% in the UC group (P < .05). Mean change in systolic and diastolic blood pressures was -8 +/- 15 and -5 +/- 9 mm Hg in the CCR group compared with a mean change of -0.8 +/- 15 and -0.2 +/- 7 mm Hg in the UC group (P < .05). Patients with IGT attending CCR obtained a significantly higher exercise capacity compared with patients in the UC group (P < .05). CONCLUSIONS: In a group of patients with impaired glucose metabolism attending CCR, an intensified multifactorial intervention with an integrated diabetes module was more efficient in improving risk factor control than UC. Besides the improvement in the exercise capacity of patients with IGT, in patients with T2DM, both HbA1c and blood pressure were lowered to a level that has been shown to reduce both cardiac and diabetic complications. These findings have important implications for patients with impaired glucose metabolism in the future settings of CCR.

Exploring factors influencing HbA1c and psychosocial outcomes in people with type 1 diabetes after training in advanced carbohydrate counting.

AIMS: The purpose of this secondary analysis of the StenoABC Study was to identify determinants of the changes in HbA1c observed after training of people with type 1 diabetes in advanced carbohydrate counting (ACC) and automated bolus calculator (ABC) use, and further to investigate psychosocial effects of these insulin dosing approaches. METHODS: Validated diabetes-specific questionnaires were used to assess diabetes treatment satisfaction, problem areas in diabetes, fear of hypoglycemia and diabetes dependent quality of life before and one year after the training. In addition, numeracy was tested (using a non-validated test developed specifically for this study) and behavioral measures (number of daily blood glucose measurements and self-reported use of ACC) were obtained. Associations between change in HbA1c and these measures plus sex, age, diabetes duration and BMI were tested. RESULTS: Numeracy was the only baseline predictor of yearly change in HbA1c identified. Higher levels of numeracy were associated with greater reductions in HbA1c (P=0.031). No associations between change in HbA1c and the behavioral measures investigated were found, nor were any clinically relevant associations between changes in HbA1c and questionnaire scores. Treatment satisfaction increased in all users of ACC (P<0.001). People who also used an ABC reported significantly lower levels of fear of hypoglycemia than people who practiced ACC without such device (P=0.005). CONCLUSIONS: Improvements in HbA1c after training in ACC were inversely related to numeracy. Use of an ABC did not compensate for poor numeracy skills. However, device use reduced fear of hypoglycemia compared with ACC without ABC use.

Designing a Self-Management App for Young People With Type 1 Diabetes: Methodological Challenges, Experiences, and Recommendations.

BACKGROUND: Young people with type 1 diabetes often struggle to self-manage their disease. Mobile health (mHealth) apps show promise in supporting self-management of chronic conditions such as type 1 diabetes. Many health care providers become involved in app development. Unfortunately, limited information is available to guide their selection of appropriate methods, techniques, and tools for a participatory design (PD) project in health care. OBJECTIVE: The aim of our study was to develop an mHealth app to support young people in self-managing type 1 diabetes. This paper presents our methodological recommendations based on experiences and reflections from a 2-year research study. METHODS: A mixed methods design was used to identify user needs before designing the app and testing it in a randomized controlled trial. App design was based on qualitative, explorative, interventional, and experimental activities within an overall iterative PD approach. Several techniques and tools were used, including workshops, a mail panel, think-aloud tests, and a feasibility study. RESULTS: The final mHealth solution was "Young with Diabetes" (YWD). The iterative PD approach supported researchers and designers in understanding the needs of end users (ie, young people, parents, and health care providers) and their assessment of YWD, as well as how to improve app usability and feasibility. It is critical to include all end user groups during all phases of a PD project and to establish a multidisciplinary team to provide the wide range of expertise required to build a usable and useful mHealth app. CONCLUSIONS: Future research is needed to develop and evaluate more efficient PD techniques. Health care providers need guidance on what tools and techniques to choose for which subgroups of users and guidance on how to introduce an app to colleagues to successfully implement an mHealth app in health care organizations. These steps are important for anyone who wants to design an mHealth app for any illness.

Changes in HbA1c and Weight Following Transition to Continuous Subcutaneous Insulin Infusion Therapy in Adults With Type 1 Diabetes.

BACKGROUND: Historically, intensive insulin therapy for type 1 diabetes (T1D) has improved glycemic control at the risk of adverse weight gain. The impact of continuous subcutaneous insulin infusion therapy (CSII) on weight in the current era remains unknown. We assessed changes in hemoglobin A1c (HbA1c) and weight in adults with T1D transitioning to CSII at 2 diabetes centers in Denmark and the United States. METHODS: Patients with T1D, aged ≥18 years, managed with multiple daily injections (MDI) who transitioned to CSII between 2002 and 2013 were identified using electronic health record data from the Steno Diabetes Center (n = 600) and Joslin Diabetes Center (n = 658). Changes in HbA1c and weight after 1 year was assessed overall and by baseline HbA1c cut points. Multivariate regression assessed correlates of HbA1c reduction. RESULTS: In adults with T1D transitioning to CSII, clinically significant HbA1c reductions were found in patients with baseline HbA1c 8.0-8.9% (Steno, -0.7%; Joslin, -0.4%) and baseline HbA1c ≥9.0% (Steno, -1.1%; Joslin, -0.9%) ( P < .005 for all). Overall, there was no significant change in weight after 1 year at either center. Modest (<2%) weight gain was noted in patients with baseline HbA1c ≥9% at Steno (1.1 ± 0.3 kg, P < .0001) and Joslin (1.7 ± 1.1, P < .005). In multivariate models, HbA1c reduction was associated with higher HbA1c, older age, female sex at Steno ( R2 = .28, P < .005), but only higher baseline HbA1c at Joslin ( R2 = .19, P < .005). CONCLUSION: Adults with T1D with suboptimal glycemic control significantly improved HbA1c without a negative impact on weight 1 year after transitioning from MDI to CSII.

Retinal characteristics during 1 year of insulin pump therapy in type 1 diabetes: a prospective, controlled, observational study.

PURPOSE: To investigate changes in retinal metabolism, function, structure and morphology in relation to initiation of insulin pump therapy (continuous subcutaneous insulin infusion, CSII). METHODS: Visual acuity, retinopathy level, dark adaptation kinetics, retinal and subfoveal choroidal thickness, macular perfusion velocities, retinal vessel diameters and blood oxygen saturations were measured at baseline and after 1, 4, 16, 32 and 52 weeks in 31 patients with type 1 diabetes who started CSII and 20 patients who continued multiple daily insulin injections (MDI). RESULTS: One year of CSII reduced haemoglobin A1c (HbA1c ) by 1.6% (17.8 mmol/mol) compared with 0.3% (3.1 mmol/mol) in the MDI group (p < 0.0001). Central retinal thickness increased by 1.5% in the CSII group (within-group p = 0.0098; between-group p = 0.063) without producing macular oedema. No detectable change was found in any other primary outcome measure. The proportion of patients with retinopathy worsening did not differ between groups. At baseline, longer disease duration was associated with higher retinal artery oxygen saturation (p = 0.014) and lower macular venous perfusion velocity (p = 0.045). CONCLUSION: One year of CSII led to an HbA1c reduction relative to continued MDI and a small increase in retinal thickness but not to early retinopathy worsening or to changes in retinal vascular, structural or functional characteristics. Longer duration of type 1 diabetes appears to be associated with lower macular venous perfusion velocity and higher retinal artery oxygen saturation. The latter could potentially reflect cumulative glycaemia.