Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes

This is a prospective, open-label, multicenter, 1-year randomized control trial, followed by an optional 1-year extension. Based upon computed number of needed participants, 112 patients aged 2-17.9 with a diagnosis of T1D within 3-6 months, trained for meal carbohydrate counting (independently or with their parents/guardians) will be enrolled after written informed consent. All participants will be trained to guide their insulin doses from the data of Dexcom G6 CGM system during a 30-day run-in phase. Downloaded CGM data, measured HbA1c and stimulated C-peptide levels and answered study questionnaires at randomization visit will serve as baseline reference. The participants will be randomized 1:1 to either HCL or their usual insulin therapy by MDI or insulin pump (control group). Participants allocated to HCL and their parents/guardians will be trained to the study AID system. Safety phone visits will be scheduled 48 hours, 1 week and 2 weeks after HCL initiation. The participants randomized to the control group will go on using their usual insulin treatment while using the Dexcom G6 data to guide their insulin doses. Outpatient visits will occur every 3 months for one year in both study groups for the monitoring of glucose control (and HCL system functioning if applicable), safety and protocol adherence. At one year, study primary endpoint will be assessed, as well as all secondary study endpoints using a repeated measure ANOVA with within/between factor. After one year, the participants and their parents/guardians of the control group will be offered to switch to HCL with the study system for one year while the initial HCL system group will be offered to keep this therapy for an additional year, with quarterly monitoring visits in the whole population for this optional extension phase of the study. At the end of this extension, all study endpoints will be re-assessed.

The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)

Foot ulcers among diabetics are common. In 2015, around 20,000 patients in the Netherlands had a diabetic foot ulcer.1 A study using data from Dutch general practices found a prevalence rate of 0.50% and a 4-year prevalence rate of 2.85%.2 For Europe, Zhang et al. estimated a pooled prevalence of 5.1% (95%CI: 4.1-6.0%).3 Prevalence rates increase with age. The underlying mechanism of diabetic foot ulcers is most often solely neuropathy (60 to 70%), 15 to 20% have peripheral artery disease (PAD) only, and 15 to 20% have a mixture of both.4 Diabetic foot is more prevalent in males and more prevalent in type 2 diabetes than in type 1 diabetes3. Ulcers in patients without diabetes are mostly caused by venous insufficiency.5 Ulcers have a slow healing tendency. Around 15 percent of diabetic patients with an ulcer eventually have to amputate (a part of) the leg.1 Good wound care is therefore important. However, wound care can be delayed in the presence of a contact allergy. Contact allergy (synonym for contact sensitivity) is defined as an altered immune status of an individual induced by a particular sensitizing substance, a contact allergen. An individual in whom contact allergy has been induced will develop a secondary immune response if there is skin exposure to the same (or cross-reacting) allergen. This process is called elicitation, and will manifest as allergic contact dermatitis (type IV hypersensitivity).6 Allergic contact dermatitis, also termed allergic contact eczema, is defined as an inflammatory skin reaction caused by direct contact with noxious agents in the environment as a result of contact allergy. Among patients with venous leg ulcers contact allergies is seen in around 50 percent of which 10-20% for wound dressings.7-10 The prevalence of contact allergies is getting higher and also increasing with the duration of the ulcer. 8,10 Wound dressings can cause allergic contact eczema (allergic contact dermatitis). At present, the prevalence of contact allergies for wound dressings in diabetic patients with foot ulcers is unknown. With this study we want to gain insight in the prevalence of contact allergies in patients with diabetic foot ulcers and investigate if the prevalence of contact allergies among diabetic patients is as high as the prevalence in patients with venous leg ulcers. Objective of the study: The primary objective of this study is to determine the prevalence of contact allergies in patients with diabetic foot ulcers. Study design: This is a prospective, multi-centre study. Study population: The study population are high risk diabetic patients with a foot ulcer visiting the multidisciplinary consultation hour for diabetics at the clinic. Diabetic patients are patients diagnosed with type 1 or type 2 diabetes. Primary study parameters/outcome of the study: The presence of contact allergy for wound dressings Secundary study parameters/outcome of the study (if applicable): The following factors will be gathered at baseline: - Age - Gender - Diabetes type - Duration of diabetes - Medication use - Ulcer characteristics like type, size, duration, progress (TEXAS classification) - Number of past foot ulcers - Duration of past foot ulcers - Known allergies or atopy constitution - Presence of allergic contact dermatitis around the wound - Doses corticosteroid or antihistaminic therapy (not during PATCH testing) - History of eczema Parameters to define if there are other mechanisms besides diabetics underlying the ulcer: - Ankle brachial index , toe pressure measurement or Transcutaneous oxygen pressure (TcPo2) - Venous insufficiency which is measured by a venous duplex, if applicable Parameters related with contact allergy or parameters that can influence the development of a contact allergy: - Known allergy. If yes, which allergy/allergies? - Duration of current ulcus cruris - Number of past ulcers - Treatment with wound dressing(s) current episode: - Duration of ulcer - Treatment with wound dressing(s) prior episode(s) - Prevalence of allergic contact dermatitis Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable): Not applicable

Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.