Time in rANge vs. Time in nOrmal Glycemia for Better Glycemic Control
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorUniversity Hospital, Motol
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Structured Diabetes Education
- Automated Insulin Delivery (AID) System Adjustment
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Motol
Lead sponsor
Schneider Children's Medical Center, Israel
Collaborator
Medical University of Warsaw
Collaborator
Source ClinicalTrials.gov