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

September 14, 2026 updated by: Sheba Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Recruiting
        • Sheba medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
trends (e.g., hyperglycemia, hypoglycemia) and send automated WhatsApp alerts
Behavioral: Tele-diabetes Remote System

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
No Intervention: Control
Participants in this arm will continue with standard care for managing Type 1 Diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
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.
CGM data - TIR - time in range, TIIR- time in tight range , hypoglycemia and hyperglycemia events, GMI, CV
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Treatment
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.
Time of CGM use
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
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
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
Time Frame: 3 months post-enrollment.
A satisfaction questionnaire of the digital tool
3 months post-enrollment.
Number of hospitalizations
Time Frame: 3 months past enrollment
Number of hospitalizations
3 months past enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

September 14, 2026

First Submitted That Met QC Criteria

September 14, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8391-21-SMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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