Aims/hypothesis There is a lack of e-health systems that integrate the complex variety of aspects relevant for diabetes self-management. We developed and field-tested an e-health system (POWER2DM)... Show moreAims/hypothesis There is a lack of e-health systems that integrate the complex variety of aspects relevant for diabetes self-management. We developed and field-tested an e-health system (POWER2DM) that integrates medical, psychological and behavioural aspects and connected wearables to support patients and healthcare professionals in shared decision making and diabetes self-management.Methods Participants with type 1 or type 2 diabetes (aged >18 years) from hospital outpatient diabetes clinics in the Netherlands and Spain were randomised using randomisation software to POWER2DM or usual care for 37 weeks. This RCT assessed the change in HbA(1c) between the POWER2DM and usual care groups at the end of the study (37 weeks) as a primary outcome measure. Participants and clinicians were not blinded to the intervention. Changes in quality of life (QoL) (WHO-5 Well-Being Index [WHO-5]), diabetes self-management (Diabetes Self-Management Questionnaire - Revised [DSMQ-R]), glycaemic profiles from continuous glucose monitoring devices, awareness of hypoglycaemia (Clarke hypoglycaemia unawareness instrument), incidence of hypoglycaemic episodes and technology acceptance were secondary outcome measures. Additionally, sub-analyses were performed for participants with type 1 and type 2 diabetes separately.Results A total of 226 participants participated in the trial (108 with type 1 diabetes; 118 with type 2 diabetes). In the POWER2DM group (n=111), HbA(1c) decreased from 60.6 +/- 14.7 mmol/mol (7.7 +/- 1.3%) to 56.7 +/- 12.1 mmol/mol (7.3 +/- 1.1%) (means +/- SD, p<0.001), compared with no change in the usual care group (n=115) (baseline: 61.7 +/- 13.7 mmol/mol, 7.8 +/- 1.3%; end of study: 61.0 +/- 12.4 mmol/mol, 7.7 +/- 1.1%; p=0.19) (between-group difference 0.24%, p=0.008). In the sub-analyses in the POWER2DM group, HbA(1c) in participants with type 2 diabetes decreased from 62.3 +/- 17.3 mmol/mol (7.9 +/- 1.6%) to 54.3 +/- 11.1 mmol/mol (7.1 +/- 1.0%) (p<0.001) compared with no change in HbA(1c) in participants with type 1 diabetes (baseline: 58.8 +/- 11.2 mmol/mol [7.5 +/- 1.0%]; end of study: 59.2 +/- 12.7 mmol/mol [7.6 +/- 1.2%]; p=0.84). There was an increase in the time during which interstitial glucose levels were between 3.0 and 3.9 mmol/l in the POWER2DM group, but no increase in clinically relevant hypoglycaemia (interstitial glucose level below 3.0 mmol/l). QoL improved in participants with type 1 diabetes in the POWER2DM group compared with the usual care group (baseline: 15.7 +/- 3.8; end of study: 16.3 +/- 3.5; p=0.047 for between-group difference). Diabetes self-management improved in both participants with type 1 diabetes (from 7.3 +/- 1.2 to 7.7 +/- 1.2; p=0.002) and those with type 2 diabetes (from 6.5 +/- 1.3 to 6.7 +/- 1.3; p=0.003) within the POWER2DM group. The POWER2DM integrated e-health support was well accepted in daily life and no important adverse (or unexpected) effects or side effects were observed.Conclusions/interpretation POWER2DM improves HbA(1c) levels compared with usual care in those with type 2 diabetes, improves QoL in those with type 1 diabetes, improves diabetes self-management in those with type 1 and type 2 diabetes, and is well accepted in daily life.Trial registration ClinicalTrials.gov NCT03588104.Funding This study was funded by the European Union's Horizon 2020 Research and Innovation Programme (grant agreement number 689444). Show less
This study assesses the association between sleep duration and plasma lipid profiles in people with diabetes mellitus (DM). Sleep duration data were obtained in 91 patients from the POWER2DM study ... Show moreThis study assesses the association between sleep duration and plasma lipid profiles in people with diabetes mellitus (DM). Sleep duration data were obtained in 91 patients from the POWER2DM study (NCT03588104). The patients were divided in tertiles, based on their sleep duration, and blood samples were obtained at the beginning and after 9 months. Significant differences were found, specifically, patients in Tertile 3 (>= 7.51 h) showed lower plasma levels of high-density lipoprotein cholesterol HDL-c (p < 0.05), apolipoprotein A1 (apo-A1; p < 0.05) and low HDL-c/apo-A1 ratio (p < 0.05). This study shows that sleep duration is associated with plasma lipid profiles in people with DM. Show less
Uitbeijerse, B.S.; Nijhoff, M.F.; Sont, J.K.; Koning, E.J.P. de 2020
In order to assess beta cell secretory capacity after islet transplantation, standardized mixed meal stimulation tests are often used. But these tests are cumbersome and the effect of exogenous... Show moreIn order to assess beta cell secretory capacity after islet transplantation, standardized mixed meal stimulation tests are often used. But these tests are cumbersome and the effect of exogenous insulin on the test results is unclear. The aim of our study was to determine to what extent fasting glycemic indices can estimate stimulated beta cell function in islet transplant recipients with and without basal insulin. In total 100 mixed meal stimulation tests, including 31 with concurrent basal insulin treatment, were performed in 36 islet transplant recipients. In a multivariate model, fasting C-peptide and fasting glucose together estimated peak C-peptide withR(2) = .87 and area under the curve (AUC) C-peptide with aR(2) = .93. There was a larger increase of glucose during tests in which exogenous insulin was used (+7.9 vs +5.3 mmol/L,P < .001) and exogenous insulin use was associated with a slightly lower estimated peak C-peptide (relative change: -15%,P = .02). In islet transplant recipients the combination of fasting C-peptide and glucose can be used to accurately estimate stimulated beta cell function after a mixed meal stimulation test, whether exogenous basal insulin is present or not. These data indicate that graft function can be reliably determined during exogenous insulin treatment and that regular islet graft stimulation tests can be minimized. Show less
