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

NCT07828106 | Recruiting DMC

• 1 other identifier: 8391-21-SMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1 Diabetes; Mobile Health Platform; Mobile Health Technology (mHealth); Mobile Health; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Glycemic control

  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 Outcomes (4)

• 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.

• 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

  3 months post-enrollment.

• Number of hospitalizations

  3 months past enrollment

Study Arms (2)

intervention

EXPERIMENTAL

trends (e.g., hyperglycemia, hypoglycemia) and send automated WhatsApp alerts

Behavioral: Tele-diabetes Remote System

Control

NO INTERVENTION

Participants in this arm will continue with standard care for managing Type 1 Diabetes

Interventions

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

intervention

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Noah Gruber, MD

CONTACT

+97235305015; noah.gruber@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

IL (1)