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

NCT07376850 | Not Yet Recruiting

• 1 other identifier: TANGO
• Study Type: interventional
• Target: 120
• Locations: 3 countries
• Sites: 3

Brief 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

Conditions

Diabetes; Diabetes (DM); Diabetes Type 1

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  Change in TIR over 12 months (between M0 and M12) between TING and TIR groups

  12 months

Secondary Outcomes (6)

• Diabetes-Related Emotional Distress in Pediatric Participants (PAID-Teen

  At enrollment, 6 months and 12 months

• Participant Perceptions of Diabetes Technology - INSPIRE Patient Scale

  At enrollment, 6 months and 12 months

• Quality of Life (QoL) Related to Diabetes Technology - INSPIRE Parent/Caregiver Scale

  At enrollment, 6 months and 12 months

• Parent/Caregiver Fear of Hypoglycemia (HFS-P)

  At enrollment, 6 months and 12 months

• Parent/Caregiver Fear and Behaviors Related to Hyperglycemia (HAQ)

  At enrollment, 6 months and 12 months

Other Outcomes (6)

• Exploratory endpoints

  12 months

• Exploratory endpoints

  12 months

• Exploratory endpoints

  12 months

Study Arms (2)

TIR group

ACTIVE COMPARATOR

Participants in this group will follow the current standard international clinical guidelines, targeting a glycemic range of 3.9-10.0 mmol/L (70-180 mg/dL). They will receive the same level of structured multidisciplinary education and clinical follow-up as the intervention group, but calibrated to the standard 70-180 mg/dL range.

Other: Structured Diabetes Education

TING group

EXPERIMENTAL

Participants in this group will target a tighter glycemic range of 3.9-7.8 mmol/L (70-140 mg/dL). Their CGM and insulin pump settings will be adjusted by their physician to support this narrower range. Participants will receive structured education focused on achieving this tighter target.

Other: Structured Diabetes Education; Other: Automated Insulin Delivery (AID) System Adjustment

Interventions

Structured Diabetes Education OTHER

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

TING group; TIR group

Automated Insulin Delivery (AID) System Adjustment OTHER

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

TING group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Motol: lead
• Schneider Children's Medical Center, Israel: collaborator
• Medical University of Warsaw: collaborator

Study Sites (3)

Motol University Hospital

Prague, Czechia

Location

Schneider Children's Medical Center of Israel

Petah Tikva, Israel

Location

Medical University of Warsaw

Warsaw, Poland

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 29, 2026
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IL (1); PL (1); CZ (1)