Time in rANge vs. Time in nOrmal Glycemia for Better Glycemic Control
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- Primary Endpoint
Study Overview
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
Detailed Description
This multinational, multicenter, randomized controlled trial aims to evaluate the clinical impact of targeting Time in Normal Glycemia (TING; 70-140 mg/dL) compared to the current standard, Time in Range (TIR; 70-180 mg/dL), in children and adolescents with Type 1 Diabetes (T1D).
Background and Rationale Managing glucose levels in pediatric T1D is essential for preventing long-term complications. While the international consensus currently recommends maintaining a TIR >70%, recent technological advances-such as automated insulin delivery (AID) systems and next-generation continuous glucose monitors (CGM)-now make it feasible to target narrower, more physiological glucose ranges. TING (70-140 mg/dL) has emerged as a potential new clinical metric for improved metabolic compensation. However, there is no definitive evidence yet that aiming for this tighter range leads to better long-term outcomes than the standard TIR without increasing treatment burden or psychological stress.
Study Objectives The primary objective is to determine if setting TING as the glycemic target improves CGM-derived glycemic metrics compared to the standard TIR approach.
Secondary objectives include:
Evaluating changes in HbA1c. Assessing differences in Quality of Life (QoL) and treatment burden using standardized patient and caregiver questionnaires.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
TIR group
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.
Intervention: Structured Diabetes Education (Other)
TING group
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.
Intervention: Structured Diabetes Education (Other)
TING group
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.
Intervention: Automated Insulin Delivery (AID) System Adjustment (Other)
Outcomes
Primary Outcomes
Primary Endpoint
Time Frame: 12 months
Change in TIR over 12 months (between M0 and M12) between TING and TIR groups
Secondary Outcomes
- 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)
- Diabetes-Related Emotional Distress in Parents/Caregivers (PAID-PR)(At enrollment, 6 months and 12 months)
Investigators
Zdeněk Šumník
MD, PhD
University Hospital, Motol