Diabetes Mellitus, Type 1 DiabetesNCT07828106
Feasibility and Effectiveness of Tele-diabetes Remote System on Glycemic Control and Quality of Life of Children and Youth With Type 1 Diabetes
A study testing Tele-diabetes Remote System in people with Diabetes Mellitus, Type 1 Diabetes and Mobile Health Platform, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- Diabetes Mellitus, Type 1 Diabetes, Mobile Health Platform, Mobile Health Technology (mHealth)
- What is being tested?
- Tele-diabetes Remote System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Aug 2026to 30 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Participants who are not using Dexcome Continuous Glucose Monitoring (CGM) and a closed-loop insulin pump system
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Being tested
- Tele-diabetes Remote System
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-diabetes Remote SystemBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | trends (e.g., hyperglycemia, hypoglycemia) and send automated WhatsApp alerts Receives: Behavioral: Tele-diabetes Remote System |
| Control | No intervention | Participants in this arm will continue with standard care for managing Type 1 Diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
CGM data - TIR - time in range, TIIR- time in tight range , hypoglycemia and hyperglycemia events, GMI, CV
Measured: 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
Time of CGM use
Measured: 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
Measured: 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
Measured: 3 months post-enrollment.
Number of hospitalizations
Number of hospitalizations
Measured: 3 months past enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start25 Aug 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828106
- Sponsor's protocol ID
- 8391-21-SMC
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No