Feasibility and Effectiveness of Tele-diabetes Remote System on Glycemic Control and Quality of Life of Children and Youth With Type 1 Diabetes

NCT07828106 — Not applicable, Recruiting, 100 participants, Sheba Medical Center

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Registry	NCT07828106
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	100 (Estimated)
Sponsor	Sheba Medical Center (Other gov)
Conditions	Diabetes Mellitus, Type 1 Diabetes, Mobile Health Platform, Mobile Health Technology (mHealth), Mobile Health, Telemedicine
Interventions	Tele-diabetes Remote System (Behavioral)
Dates	start 2026-08-25, primary completion 2027-04-30 (estimated), completion 2027-05-30 (estimated), first posted 2026-09-18, last updated 2026-09-18
Locations	1 site in Israel

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
intervention	Experimental	Behavioral: Tele-diabetes Remote System	trends (e.g., hyperglycemia, hypoglycemia) and send automated WhatsApp alerts
Control	No intervention		Participants in this arm will continue with standard care for managing Type 1 Diabetes

Tele-diabetes Remote System (Behavioral): 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

+Outcome measures

Primary outcomes

Glycemic control [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.]: CGM data - TIR - time in range, TIIR- time in tight range , hypoglycemia and hyperglycemia events, GMI, CV

Secondary outcomes

Adherence to Treatment [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.]: Time of CGM use
Number of emergency room visits with diabetic ketoacidosis (DKA) or hypoglycemia [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
Satisfaction score [3 months post-enrollment.]: A satisfaction questionnaire of the digital tool
Number of hospitalizations [3 months past enrollment]: Number of hospitalizations

+Eligibility

Sex: All, ages: 1 Year to 25 Years

Inclusion Criteria:

* Participants must have a confirmed diagnosis of Type 1 Diabetes Mellitus (T1DM).
* Participants must use Dexcome Continuous Glucose Monitoring (CGM)
* Must have access to a smartphone capable of receiving WhatsApp messages.
* Participants must use a closed-loop insulin pump system (also known as an artificial pancreas system) omnipod DIY or Tandem.

Exclusion Criteria:

* Participants who are not using Dexcome Continuous Glucose Monitoring (CGM) and a closed-loop insulin pump system

+Locations (1)

Facility	City	Country	Status
Sheba medical center	Ramat Gan	Israel	Recruiting