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Clinical Trials in Czechia / NCT07376850
Starting soon Not applicable

Time in rANge vs. Time in nOrmal Glycemia for Better Glycemic Control

NCT07376850 · tracked via the Priya Life Science Czechia tracker
Sponsor
University Hospital, Motol
Phase
Not applicable
Started
2026-01
Last updated
2026-01-29

Condition(s) studied

DiabetesDiabetes (DM)Diabetes Type 1

Investigational drug(s) / intervention(s)

Structured Diabetes EducationAutomated Insulin Delivery (AID) System Adjustment

Structured Diabetes Education: A comprehensive standardized guideline will be provided to recruiting physicians from all centers, including the points below: 1. Understanding CGM data and trend interpretation 2. TIR or TING concepts according to randomization, target range, consequences of hypoglycemia and hyperglycemia 3. Recognizing and management of hypoglycemia 4. Recognizing and management of hyperglycemia 5. Setting and adjusting of glycemic targets, alarms in CGM and insulin pumps, and insulin doses based on randomisation 6. Emotional coping strategies and involving family support

Automated Insulin Delivery (AID) System Adjustment: For the TING group, CGM hyperglycemia target settings will be lowered by at-least 10% from the baseline values. The extent of the adjustment will be at the discretion of the attending physician

Study summary

The TANGO study is a 12-month study involving 120 children and adolescents with Type 1 Diabetes (T1D) across the Czech Republic, Israel, and Poland who use automated insulin delivery (AID) systems.

Currently, the global standard for diabetes management is "Time in Range" (TIR), which aims to keep blood sugar levels between 70-180 mg/dL. However, newer technologies like AID systems may now allow for a tighter, more physiological goal called "Time in Normal Glycemia" (TING), which targets a range of 70-140 mg/dL.

This study will randomly assign participants to follow either the standard TIR target or the tighter TING target to see if the narrower range improves overall blood sugar control and HbA1c without increasing the risk of hypoglycemia, family stress, or daily treatment burden.

By comparing these two approaches, researchers hope to determine if clinical guidelines should be updated to reflect a more precise glucose target for children and adolescents worldwide

Eligibility

Sex
ALL
Min age
5 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of T1D per ADA criteria * Age 5.0-17.99 at the start of study * CGM use \>70% of the time during the month prior to enrollment * Maximum HbA1c of 86mmol/mol (10% in DCCT) Exclusion Criteria: * No concurrent illnesses impacting glycemia * No treatments impacting glycemia * Severe hypoglycemia documented in the 60 day period leading up to patient recruitment * Current participation in any other interventional study * Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise participant's safety * Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Motol University Hospital Prague Czechia
Schneider Children's Medical Center of Israel Petah Tikva Israel
Medical University of Warsaw Warsaw Poland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07376850 on ClinicalTrials.gov ↗ ← All trials in Czechia