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โ† Trials
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Connected Care for Type 2 Diabetes Self-Management

RecruitingNAAges 18 Years - anyAllMarche Region Regional Health Agency
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In plain words

What the trial is, and whether it could suit you

The primary objective of this Randomized Clinical Trial is to improve the self-management (SM) competencies of patients affected by Type 2 Diabetes Mellitus (T2DM) living in the Marche region (Italy) through the support of a mobile health (m-health) solution personalised by the diabetologist and integrated with the Electronic Patient Record (EPR), assessed through the change in glycated haemoglobin (HbA1c) levels (%) from baseline to the end of the intervention (primary outcome). Researchers will compare the use of the m-health solution (treated group) to usual T2DM care (control group) in determining change in HbA1c levels (%). The intervention will start at the Diabetic Centres (CADs) where patients are currently followed up and will then take place in each participant's home Participants of the treated group will: * receive dedicated training on the use of the m-health solution * r

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * patients with T2DM (as confirmed by the physician's diagnosis); * belonging to one of the 13 Diabetes Centres (CADs) of the Marche region in Italy (Pesaro, Urbino, Fano, Senigallia, Jesi, Fabriano, IRCCS-INRCA, Azienda Ospedaliera Universitaria delle Marche, Civitanova Marche, Macerata, Fermo, San Benedetto del Tronto e Ascoli Piceno); * age \> = 18; * resident in the Marche region; * HbA1c \> 7 on most recent laboratory report within the last 3 months; * no changes in diabetes medication in the previous 6 months; * no prescription for any hypoglycaemic agent within the previous 4 weeks or taking a consistent dose of one or more oral hypoglycaemic agents for more than 12 weeks; * owning smartphone/mobile phone with an internet connection; * capable to consent; * fulfilling and signing the informed consent; * with self-reported competencies of communicating verbally in local language (corresponding to a level of Italian language knowledge =\>A2 of the CEFR levels). Exclusion Criteria: * acute medical problems: myocardial infarction or stroke within 6 months, difficulty in exercise and physical activity due to spinal disease (intervertebral disc prolapse, spinal stenosis, etc.), joint disease, or major surgery at the time of screening, painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility, advanced Parkinson's disease and/or neuromuscular disorders, advanced dementia, metastatic cancer, in long-term immunosuppressant therapy, significant visual or hearing impairment, uncontrolled hypertension or other serious conditions that restrict their participation in the study, severe/major depression and other relevant psychiatric disorders; * estimated glomerular filtration rate \< 30 mL/min/1.73 m2; * plan to receive surgery that could limit physical activity during the study period; * pregnant or breastfeeding; * participation in another studies; * lack of written informed consent.
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What it tests

  • M-health solution classified as Class I Medical Devices, equipped with a CE certificate. The m-health solution will be integrated with the EPR currently used by the CADs of the Marche region
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Where

11 sites
Diabetic Center of Azienda Ospedaliero Universitaria delle Marche
Ancona, Italy
Diabetic Center of National Institute for the Care and Treatment of the Elderly (Istituto Nazionale di Ricovero e Cura per Anziani-INRCA)
Ancona, Italy
Diabetic Center of Territorial Healthcare Authority of Ancona province
Fabriano, Italy
Diabetic Center of Territorial Healthcare Authority of Ancona province
Iesi, Italy
Diabetic Center of Territorial Healthcare Authority of Ascoli Piceno province
Ascoli Piceno, Italy
Diabetic Center of Territorial Healthcare Authority of Ascoli Piceno province
San Benedetto del Tronto, Italy
Diabetic Center of Territorial Healthcare Authority of Fermo province
Fermo, Italy
Diabetic Center of Territorial Healthcare Authority of Macerata province
Civitanova Marche, Italy

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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