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

ConditionsDiabetesDiabetes (DM)Diabetes Type 1
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Structured Diabetes Education

    Other intervention

    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

    Other intervention

    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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: TIR groupActive comparator 1 intervention
Group B: TING groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Primary Endpoint

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

Time frame
12 months

Secondary outcomes

1

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

A 20-item survey assessing emotional distress. Items are scored 0-4. Unit of Measure: Standardized score (Range: 0 to 100). Interpretation: Higher scores indicate higher distress.

Time frame
At enrollment, 6 months and 12 months
2

Participant Perceptions of Diabetes Technology - INSPIRE Patient Scale

QoL questionnaire: Assesses how young patients feel about their insulin delivery systems. Unit of Measure: Score on a scale (Range: 0 to 100). Higher scores indicate higher satisfaction and more positive expectations of the device.

Time frame
At enrollment, 6 months and 12 months
3

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

Assesses parent/caregiver perceptions of automated insulin delivery systems. Each item is scored 0-4. Unit of Measure: Score on a scale (Range: 0 to 100). Interpretation: Higher scores indicate a more positive appraisal of the technology and better QoL.

Time frame
At enrollment, 6 months and 12 months
4

Parent/Caregiver Fear of Hypoglycemia (HFS-P)

A 26-item survey with two subscales: Behavior (11 items) and Worry (15 items). Items are rated from 0 (never) to 4 (very often). Unit of Measure: Total score (Range: 0 to 104). Interpretation: Higher scores indicate a greater fear of hypoglycemia.

Time frame
At enrollment, 6 months and 12 months

Other outcomes

1

Exploratory endpoints

Difference in the percentage of time in range (TIR) and time in normal glycemia (TING) at 3, 6, 9, and 12 months

Time frame
12 months
2

Exploratory endpoints

Change in time in hypoglycemia level 1 (3,0-3,8 mmol/l) and level 2 (\<3,0 mmol/l), hyperglycemia level 1 (10,1-13,9 mmol/l) and level 2 (\>13,9 mmol/l) at 3, 6, 9, and 12 months

Time frame
12 months
3

Exploratory endpoints

Change in Glycemic variability (SD, CV)

Time frame
12 months
4

Exploratory endpoint

Change in Mean glucose level

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Motol

Lead sponsor

Schneider Children's Medical Center, Israel

Collaborator

Medical University of Warsaw

Collaborator

Source ClinicalTrials.gov

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