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NCT Number: NCT07828106

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

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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Key information

Conditions

Diabetes Mellitus, Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Mobile Health Mobile Health Platform Mobile Health Technology (mHealth) Nutritional and Metabolic Diseases Telemedicine

Age range

1 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba medical center

Ramat Gan, Israel

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Satisfaction score

    Time frame: 3 months post-enrollment.

    A satisfaction questionnaire of the digital tool

  4. Number of hospitalizations

    Time frame: 3 months past enrollment

    Number of hospitalizations

Study contacts

Contact information is provided by the study sponsor or research team.

Noah Gruber, MD

CONTACT

[email protected]

+97235305015

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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