DiabetesTANGONCT07376850
Time in rANge vs. Time in nOrmal Glycemia for Better Glycemic Control
A study testing Structured Diabetes Education and Automated Insulin Delivery (AID) System Adjustment in people with Diabetes and Diabetes (DM), run by University Hospital, Motol at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Diabetes, Diabetes (DM), Diabetes Type 1
- What is being tested?
- Structured Diabetes Education and Automated Insulin Delivery (AID) System Adjustment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Czechia1 site
Motol University Hospital
Prague
Shenali Amaratunga, shenali.amaratunga@fnmotol.cz
About this study
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.
Read more
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
Read the 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.
Monitoring the safety and incidence of acute complications, such as severe hypoglycemia and diabetic ketoacidosis (DKA).
Study Design and Population The study will enroll 120 children and adolescents (ages 5.0-17.99) across three tertiary pediatric diabetes centers in the Czech Republic, Israel, and Poland. All participants must be using AID systems and have used a CGM for at least 70% of the time in the month prior to enrollment.
From the target population, we aim to recruit 25% of individuals newly diagnosed.
Intervention and Methods
Participants will be randomized 1:1 into two groups:
TING Group (Intervention): Will follow a target glucose range of 70-140 mg/dL (3.9-7.8 mmol/L).
TIR Group (Control): Will follow the standard target range of 70-180 mg/dL (3.9-10.0 mmol/L).
Both groups will receive structured education from a multidisciplinary team regarding CGM interpretation, glycemic targets, and self-management. In the TING group, CGM hyperglycemia targets will be lowered by at least 10% from baseline.
Timeline and Endpoints The study duration is 12 months. Data collection includes CGM metrics, insulin dose data, and HbA1c at 3-month intervals (Months 0, 3, 6, 9, and 12). A telephone check-up will occur 6 weeks after baseline to assess early adherence and treatment satisfaction.
Primary Endpoint: Change in TIR (70-180 mg/dL) between baseline and 12 months.
Secondary/Exploratory Endpoints: Percentage of time in TING, time in hypoglycemia (Levels 1 and 2), glycemic variability, and various QoL scores (PAID, INSPIRE, Hypoglycemia/Hyperglycemia Fear Surveys) .
Impact If targeting TING is proven beneficial and acceptable, the results of this trial could inform future clinical guidelines and redefine optimal glycemic targets for pediatric diabetes care globally.
- Conditions
- Diabetes, Diabetes (DM), Diabetes Type 1
- Being tested
- Structured Diabetes Education, Automated Insulin Delivery (AID) System Adjustment
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Diabetes EducationOther
A comprehensive standardized guideline will be provided to recruiting physicians from all centers, including the points below:
- Understanding CGM data and trend interpretation
- TIR or TING concepts according to randomization, target range, consequences of hypoglycemia and hyperglycemia
- Recognizing and management of hypoglycemia
- Recognizing and management of hyperglycemia
- Setting and adjusting of glycemic targets, alarms in CGM and insulin pumps, and insulin doses based on randomisation
- Emotional coping strategies and involving family support
Automated Insulin Delivery (AID) System AdjustmentOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Structured Diabetes Education; Other: Automated Insulin Delivery (AID) System Adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
Change in TIR over 12 months (between M0 and M12) between TING and TIR groups
Measured: 12 months
Secondary outcomes (6)
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.
Measured: At enrollment, 6 months and 12 months
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.
Measured: At enrollment, 6 months and 12 months
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.
Measured: At enrollment, 6 months and 12 months
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.
Measured: At enrollment, 6 months and 12 months
Parent/Caregiver Fear and Behaviors Related to Hyperglycemia (HAQ)
QoL questionnaire: Measures the extent of potentially problematic attitudes and behaviors used to avoid high blood sugar. It consists of 22 items rated 0-4.
Unit of Measure: Total score (Range: 0 to 88). Interpretation: Higher scores indicate greater levels of hyperglycemia-related worry and more frequent avoidance behaviors.
Measured: At enrollment, 6 months and 12 months
Diabetes-Related Emotional Distress in Parents/Caregivers (PAID-PR)
A 18-item scale measuring the emotional burden of caregiving. Items are rated from 0 (no problem) to 4 (serious problem).
Unit of Measure: Total score (Range: 0 to 72). Interpretation: Higher scores reflect greater diabetes-specific emotional distress.
Measured: At enrollment, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Collaborators
- Schneider Children's Medical Center, Israel, Medical University of Warsaw
- Responsible party
- Principal investigator, Zdeněk Šumník, University Hospital, Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376850
- Sponsor's protocol ID
- TANGO
- Acronym
- TANGO
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the anonymised participants' data on individual request
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time in rANge vs. Time in nOrmal Glycemia for Better Glycemic Control
- ClinicalTrials.gov ID
- NCT07376850
- Acronym / sponsor ID
- TANGO / TANGO
- Conditions
- Diabetes, Diabetes (DM), Diabetes Type 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Collaborators
- Schneider Children's Medical Center, Israel, Medical University of Warsaw
- Study start
- Jan 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Monitoring the safety and incidence of acute complications, such as severe hypoglycemia and diabetic ketoacidosis (DKA).
Study Design and Population The study will enroll 120 children and adolescents (ages 5.0-17.99) across three tertiary pediatric diabetes centers in the Czech Republic, Israel, and Poland. All participants must be using AID systems and have used a CGM for at least 70% of the time in the month prior to enrollment.
From the target population, we aim to recruit 25% of individuals newly diagnosed.
Intervention and Methods
Participants will be randomized 1:1 into two groups:
TING Group (Intervention): Will follow a target glucose range of 70-140 mg/dL (3.9-7.8 mmol/L).
TIR Group (Control): Will follow the standard target range of 70-180 mg/dL (3.9-10.0 mmol/L).
Both groups will receive structured education from a multidisciplinary team regarding CGM interpretation, glycemic targets, and self-management. In the TING group, CGM hyperglycemia targets will be lowered by at least 10% from baseline.
Timeline and Endpoints The study duration is 12 months. Data collection includes CGM metrics, insulin dose data, and HbA1c at 3-month intervals (Months 0, 3, 6, 9, and 12). A telephone check-up will occur 6 weeks after baseline to assess early adherence and treatment satisfaction.
Primary Endpoint: Change in TIR (70-180 mg/dL) between baseline and 12 months.
Secondary/Exploratory Endpoints: Percentage of time in TING, time in hypoglycemia (Levels 1 and 2), glycemic variability, and various QoL scores (PAID, INSPIRE, Hypoglycemia/Hyperglycemia Fear Surveys) .
Impact If targeting TING is proven beneficial and acceptable, the results of this trial could inform future clinical guidelines and redefine optimal glycemic targets for pediatric diabetes care globally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIR group | Active comparator | Other: Structured Diabetes EducationParticipants 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. |
| TING group | Experimental | Other: Structured Diabetes Education, Other: Automated Insulin Delivery (AID) System AdjustmentParticipants 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Diabetes EducationA 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 | Other | TING group, TIR group |
| Automated Insulin Delivery (AID) System AdjustmentFor 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 | Other | TING group |
Primary outcome
Primary Endpoint
Time frame: 12 months
Change in TIR over 12 months (between M0 and M12) between TING and TIR groups
6 secondary outcomes
Diabetes-Related Emotional Distress in Pediatric Participants (PAID-Teen
Time frame: At enrollment, 6 months and 12 months
Participant Perceptions of Diabetes Technology - INSPIRE Patient Scale
Time frame: At enrollment, 6 months and 12 months
Quality of Life (QoL) Related to Diabetes Technology - INSPIRE Parent/Caregiver Scale
Time frame: At enrollment, 6 months and 12 months
Parent/Caregiver Fear of Hypoglycemia (HFS-P)
Time frame: At enrollment, 6 months and 12 months
Parent/Caregiver Fear and Behaviors Related to Hyperglycemia (HAQ)
Time frame: At enrollment, 6 months and 12 months
Diabetes-Related Emotional Distress in Parents/Caregivers (PAID-PR)
Time frame: At enrollment, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes. We plan to share the anonymised participants' data on individual request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Diabetes Education and Automated Insulin Delivery (AID) System Adjustment in people with Diabetes and Diabetes (DM), run by University Hospital, Motol at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia, Israel, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.