An interventional study of TreC Diabete App in Diabetes type2, sponsored by Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-07-20.
Sponsored by Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento · Not applicable, Interventional, and Other
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.
Type 2 diabetes mellitus (T2DM) is a non-communicable disease representing one of the most serious public health challenges of the 21st century. Its incidence continues to rise in both developed and developing countries, causing the death of 1.5 million people every year. The use of technology (e.g. Smartphone application - App) in the health field has progressively increased as it has been proved effective in helping some individuals manage their long-term diseases. Therefore, it has the potential to reduce health service utilization and its related costs. The objective of this study is to evaluate the impact of using a digital platform called "TreC Diabete" embedded into a novel organizational asset targeting poorly controlled T2DM individuals in the Autonomous Province of Trento (PAT), Italy.This trial was designed as a multi-center, open-label, randomised, superiority study with two parallel-groups and a 1:1 allocation ratio. Individuals regularly attending outpatients diabetes clinics, providing informed consent are randomised to be prescribed TreC Diabete platform or not as part of their personalised care plan. Healthcare staff members will remotely assess the data shared by the participants through the App by using a dedicated online medical dashboard. The primary end-point is the evaluation of the Hb1Ac level at 12-month post-randomisation. Data will be analysed on an intention-to-treat (ITT) basis.This trial is the first conducted in the PAT for the use of an App specifically designed for individuals with poorly controlled T2DM. If the effects of introducing this specific App within a new organizational asset are positive, the digital platform will represent a possible way for people diagnosed with T2DM to better manage their health in the future. Results will be disseminated through conferences and peer-reviewed journals once the study is completed.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Sixty individuals allocated to the intervention group are prescribed with the TreC Diabete App for 12 months, one of the App created within the so-called TreC platform, which enables citizens from PAT to access, manage and share information about their health and wellbeing in the context of telemedicine. The use of the App is additional to the standard care, based on the integrated preventive and diagnostic care pathway (called "Percorsi Preventivi Diagnostici Terapeutici Assistenziali - PPDTA" in Italian).An appointment with the outpatient diabetes clinic staff is scheduled at 6 and 12 month from the first visit (taking place within 30 days of the study entry), either through telemedicine (remote visit) or face-to-face.
Other: TreC Diabete App
Sixty individuals are allocated to the control group. These participants will receive standard care, which is the best care for T2DM in line with the integrated preventive and diagnostic care pathway (called "Percorsi Preventivi Diagnostici Terapeutici Assistenziali - PPDTA" in Italian).An appointment with the outpatient diabetes clinic staff is scheduled at 6 and 12 month from the first visit (taking place within 30 days of the study entry), either through telemedicine (remote visit) or face-to-face. Participants are asked to register their data as per routine (e.g. paper diary).
Participants can download the App from Google Play or Apple Store and activate the App as soon as the clinician provides them a unique activation code, created through an online medical dashboard. The dashboard allows the interaction between healthcare staff and the participant through the use of a chat or a video-chat. Participants are asked to register some information in the App at set times (e.g. blood pressure). Reminders are periodically sent to remember the participants to perform some tasks. Clinicians will periodically check the information entered by the participant (min frequency 45 days).
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.
Time frame: 12 months
Proportion of participants with Hb1Ac <53mmol/mol
Proportion of participants with Hb1Ac \<53mmol/mol within the two arms
Time frame: 12 months
Hb1Ac mean changes
Difference in the participants' HbA1c level at different time frame other than at 12 months
Time frame: 3 months, 6 months and 9 months
Number of hypoglycemic episodes
Frequency of hypoglycemic episodes within the two arms
Time frame: 12 months
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)
Time frame: 12 months
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)
Time frame: 3 months, 6 months, 9 months, 12 months
Effect on weight
Effect on weight for the app users
Time frame: 3 months, 6 months, 9 months and 12 months
Level of physical activity
Information collected through specific questionnaires
Time frame: 3 months, 6 months, 9 months and 12 months
Quality of life score changes
Changes in quality of life scores for participants of both arms through a specific questionnaire
Time frame: 12 months
Satisfaction and usability score of the App
Satisfaction and usability score of the App in the intervention group only
Time frame: 12 months
Number of telemedicine visits between participants and nurses/clinicians and chat interactions
Process indicator outcome
Time frame: 3 months, 6 months, 9 months and 12 months
Number of (tele)specialist consultations
Process indicator outcome
Time frame: 3 months, 6 months, 9 months and 12 months
Number of changes in the therapeutic plan
Process indicator outcome: number of changes in the therapeutic plan (e.g. drug prescription and dosage)
Time frame: 3 months, 6 months, 9 months and 12 months
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)
Time frame: 6 months
Plan to share: Undecided — Data will not be available on an individual level. We plan to share data on their aggregated form
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Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento