Diabetes type2 Clinical Trial
— TelemechronOfficial title:
Organisational Models Supported by Technology for the Management of Diabetic Disease and Its Complications in a Diabetic Clinic Setting. A Randomised Controlled Trial Targeting Type 2 Diabetes Individuals With Non-ideal Glycemic Values
The goal of this randomised trial is to evaluate the impact of using a digital platform called "TreC Diabete" embedded into a novel organizational asset for poorly controlled type 2 diabetes individuals in the Autonomous Province of Trento (PAT). The main question aims to answer whether individuals using the "TreC Diabete" platform will improve their haemoglobin glycated level (Hb1Ac) at 12-month post-randomisation. Participants will be asked to perform some tasks and to share their data with the healthcare staff members through the platform. Control group will receive standard care.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - being diagnosed with T2DM; - aged = 18 and = 85 years old; - having an HbA1c level >7% (53 mmol/mol) and <12% (108 mmol/mol); - being able to walk without walking aids; - having provided written informed consent; - having a smartphone or a tablet and being able to download the App that will be used to insert the required data. Exclusion Criteria: - having a BMI <18 Kg/m² and >45 Kg/m²; - having a sBP <100 or >200 mmHg and/or dBP <50 or >120 mmHg; - being diagnosed with a stage 5 CKD* - being diagnosed with a NYHA stage IV; - poor collaboration (ie unwilling to modify the actual plan of control and therapy, even if not ideal) for which adherence to the study is unlikely - having no possibility of using a smartphone or a tablet - having medical conditions affecting the study participation (i.e. life expectancy < 1 year) |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Provinciale per i Servizi Sanitari | Trento | Trentino-Alto Adige |
Lead Sponsor | Collaborator |
---|---|
Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento | Fondazione Bruno Kessler, Ministero della Salute, Italy, Provincia Autonoma di Trento, TrentinoSalute4.0 |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Haemoglobin glycated (Hb1Ac) mean changes | Difference in the participants' HbA1c level between the two arms. Blood test carried out by qualified nurses and processes by the local analysis laboratory. Blood tests results are automatically registered on the Hospital Information System (HIS) and reviewed by clinicians and research staff involved in the study. | 12 months | |
Secondary | Proportion of participants with Hb1Ac <53mmol/mol | Proportion of participants with Hb1Ac <53mmol/mol within the two arms | 12 months | |
Secondary | Hb1Ac mean changes | Difference in the participants' HbA1c level at different time frame other than at 12 months | 3 months, 6 months and 9 months | |
Secondary | Number of hypoglycemic episodes | Frequency of hypoglycemic episodes within the two arms | 12 months | |
Secondary | Number of subjects reaching targeted lipid profile | Proportion of participants reaching the targeted lipid profile (LDL level <70 mg/dl and non-HDL cholesterol level <100 mg/dl) | 12 months | |
Secondary | Number of subjects reaching targeted blood pressure levels | Proportion of participants reaching the targeted BP levels (sBP <130mmHg or <140 if =65 years old) and dBP <80mmHg) | 3 months, 6 months, 9 months, 12 months | |
Secondary | Effect on weight | Effect on weight for the app users | 3 months, 6 months, 9 months and 12 months | |
Secondary | Level of physical activity | Information collected through specific questionnaires | 3 months, 6 months, 9 months and 12 months | |
Secondary | Quality of life score changes | Changes in quality of life scores for participants of both arms through a specific questionnaire | 12 months | |
Secondary | Satisfaction and usability score of the App | Satisfaction and usability score of the App in the intervention group only | 12 months | |
Secondary | Number of telemedicine visits between participants and nurses/clinicians and chat interactions | Process indicator outcome | 3 months, 6 months, 9 months and 12 months | |
Secondary | Number of (tele)specialist consultations | Process indicator outcome | 3 months, 6 months, 9 months and 12 months | |
Secondary | Number of changes in the therapeutic plan | Process indicator outcome: number of changes in the therapeutic plan (e.g. drug prescription and dosage) | 3 months, 6 months, 9 months and 12 months | |
Secondary | Time spent for telemedicine visits | Process indicator outcome: amount of time spent for telemedicine visits (calculated on the basis of the average time spent to deliver eight consecutive nursing visits and eight consecutive medical visits) | 6 months |
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