An interventional study of Tele-diabetes Remote System in Diabetes Mellitus, Type 1 Diabetes, Mobile Health Platform and Mobile Health Technology (mHealth), sponsored by Sheba Medical Center. Recruiting at 1 site in Israel. Open to participants aged 1 Year to 25 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to examine the feasibility and effectiveness of a tele-diabetes remote monitoring system on managing type 1 diabetes (T1DM) among children and adolescents. The study aims to assess whether this system, which incorporates a WhatsApp-based alert system, can improve clinical outcomes, increase adherence to treatment, enhance quality of life, and reduce healthcare utilization in this population. The main questions it aims to answer are:
Does the tele-diabetes remote system improve glycemic control (e.g., time in range [TIR], frequency of hypoglycemia and hyperglycemia, HbA1c levels)? Does it enhance adherence to treatment and overall quality of life for children and youth with T1DM? Does the system reduce the number of emergency room visits for diabetic ketoacidosis (DKA) or severe hypoglycemia, hospitalizations, and overall medical costs? Researchers will compare participants who receive WhatsApp notifications (intervention group) with those receiving standard care (control group) to evaluate differences in clinical outcomes, quality of life, and healthcare burden.
Participants will:
Receive notifications via WhatsApp messages sent by a system developed by the research team, which monitors glucose trends in real-time and sends alerts when patterns (e.g., hypoglycemia, hyperglycemia) are detected.
Participate in follow-ups supported by the hybrid medical team between routine clinic visits.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
trends (e.g., hyperglycemia, hypoglycemia) and send automated WhatsApp alerts
Behavioral: Tele-diabetes Remote System
Participants in this arm will continue with standard care for managing Type 1 Diabetes
The tele-diabetes system is a digital platform designed for remote glucose monitoring in patients with Type 1 Diabetes. The system utilizes a smart algorithm to analyze real-time glucose levels, detect trends of hyperglycemia or hypoglycemia, and send automated WhatsApp alerts to participants. These alerts provide actionable insights aimed at improving glycemic control and treatment adherence between routine clinic visits. The system also includes a monitoring dashboard accessed by researchers and clinicians, enabling them to track the alerts sent. The medical team follows a structured escalation protocol: After two consecutive alerts: A registered dietitian contacts the participant to provide personalized dietary and behavioral guidance. If an additional alert is detected after this contact: A virtual physician consultation is scheduled to adjust treatment as needed. If another alert follows: The participant is invited for an in-clinic visit for detailed evaluation and intervention
Glycemic control
CGM data - TIR - time in range, TIIR- time in tight range , hypoglycemia and hyperglycemia events, GMI, CV
Time frame: Baseline (prior to receipt of the first WhatsApp alert) and monthly assessments after the first alert, at 1 month, 2 months, and 3 months post-enrollment.
Adherence to Treatment
Time of CGM use
Time frame: Baseline (prior to receipt of the first WhatsApp alert) and monthly assessments after the first alert, at 1 month, 2 months, and 3 months post-enrollment.
Number of emergency room visits with diabetic ketoacidosis (DKA) or hypoglycemia
Number of emergency room visits with diabetic ketoacidosis (DKA) or hypoglycemia
Time frame: Baseline (prior to receipt of the first WhatsApp alert) and monthly assessments after the first alert, at 1 month, 2 months, and 3 months post-enrollment.
Satisfaction score
A satisfaction questionnaire of the digital tool
Time frame: 3 months post-enrollment.
Number of hospitalizations
Number of hospitalizations
Time frame: 3 months past enrollment
Started Aug 2026 (actual). Primary completion is estimated for Apr 2027, 8 months after the start.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 8 months is below that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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