Type 1 DiabetesTightT1AHCLNCT06466967
Clinical Utility of Tight Objectives of Advanced Hybrid Closed-loop Systems Among Type 1 Diabetes Patients (TightT1AHCL)
An observational study of Type 1 Diabetes, run by Castilla-La Mancha Health Service at 1 site in Spain.
Trial summary
Diabetes is a chronic disease with a relevant public health burden. Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Advanced hybrid closed-loop CamAPS FX
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2024to 15 Mar 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with type 1 diabetes and poor prior glycemic control, regardless previous treatment, attended in the Public Health System of Castilla-La Mancha in the Health Area of the Ciudad Real General University Hospital
Who may be able to join
- Patients with type 1 diabetes.
- Age greater than or equal to 18 years.
- HbA1c > 7% (previous poor glycemic control condition).
- Prior treatment with MDI or aHCL.
Who cannot join
- Other types of diabetes.
- Pregnancy or pre-conception control.
- Uncontrolled psychiatric disease.
- Current or previous treatment with CamAPS-Ypsopump.
- No glucometric data available during the periods under study.
- History of severe hypoglycemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Utility of a Tight Glucose Objectives Through Advanced Hybrid Closed-loop Systems in Adult Patients With Type 1 Diabetes and Poor Glycemic Control
Diabetes is a chronic disease with a relevant public health burden. Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications. Therefore, the key to prevent and/or reduce the development of these chronic complications lies in an adequate and strict glycemic control.
This study consist of a prospective analytical clinical study in patients with type 1 diabetes (T1D). The main objective is to analyze the effect on time in range (TIR, 70-180 mg/dL) of interstitial glucose after switching to a tighter glucose objective in advanced hybrid closed-loop (AHCL) treated adult T1D patients previously treated with multiple dose insulin injection (MDI) or other AHCL systems without tighter glucose objective function.
Read the detailed description
Diabetes is a chronic disease with a relevant public health burden. T1D is characterized by the autoimmune destruction of insulin-producing pancreatic beta cells, which requires the administration of exogenous insulin for its treatment. Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications that affect quality of life, as well as morbidity and mortality due to the deleterious long-term effects of suboptimal control. Therefore, the key to prevent and/or reduce the development of these complications lies in adequate and strict glycemic control.
On the one hand, the use of advanced hybrid closed-loop (AHCL) systems in patients with T1D is associated with improved glycemic control and quality of life in both controlled clinical trials and real-life studies. Since 2021, AHCL systems are considered the standard of care, ahead of traditional MDI. On the other hand, among the adjustment parameters of these systems, each AHCL offers different target levels of glycemic control. There is previous evidence that correlates the use of the more intense modes offered by each of the systems with substantial increases in TIR, improvement in the other glycometric variables, as well as the development of acute or chronic complications. In this regard, a new AHCL system has recently been introduced in Spain: CamAPS FX. It is the first AHCL system with the availability of setting lycemic control targets below the traditional 100 mg/dL limit. This system allows glycemic objective as low as 80 mg/dL.
However, there is no information on the benefits and safety of using tighter control targets. The main objective of this study is to analyze the effect on TIR after switching to a tighter glucose objective throught AHCL among adult T1D patients previously treated with MDI or other AHCL systems without this feature.
This is monocenter prospective analytical clinical study (non-randomized). The target population will be adult T1D patients not meeting glycemic control goals followed in Ciudad Real General University Hospital.
- Conditions
- Type 1 Diabetes
- Being tested
- Advanced hybrid closed-loop CamAPS FX
- Keywords
- Type 1 Diabetes, advanced hybrid closed-loop, tight time in range, artificial pancreas
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced hybrid closed-loop CamAPS FXDevice
Also called Ypsopump, CamAPS FX
Treatment with a strict programmed glucose target (80-99 mg/dL).
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes patients treated with AHCL (CamAPS-Ypsopump) | Patients with type 1 diabetes on treatment with AHCL (CamAPS-Ypsopump) and a strict programmed glucose target (80-99 mg/dL). Receives: Device: Advanced hybrid closed-loop CamAPS FX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range (TIR) differences
Percentage differences in time in range (TIR, 70-180 mg/dL) of interstitial glucose after switching to AHCL with tighter glycemic control targets.
Measured: 3 months
Secondary outcomes (23)
Time in Range (TIR) differencies among therapies
Percentage differences in time in range (TIR 70-180 mg/dL) of interstitial glucose after switching to AHCL with tighter glycemic control targets depending on previous therapy: multi-dose insulin or other AHCL systems with less stringent objectives.
Measured: 3 months
Differences between stringent glucose control targets
To analyze the possible differences on time in range (TIR) using different interstitial glucose targets (from 80 to 99 mg/dL).
Measured: 3 months
HbA1c differences
Differences in HbA1c values after switching to AHCL with tighter glycemic control targets.
Measured: 3 months
Usage of AHCL system
To assess the effect on the time spent using AHCL systems after switching: percentage of time spent using the AHCL system.
Measured: 3 months
MCG adherence
To assess the effect on the time of use of MCG after switching: percentage of MCG sensor activity time.
Measured: 3 months
Total daily insulin requirements
To assess the effect on total daily insulin requirements after switching to AHCL therapy with tighter glycemic objective.
Measured: 3 months
Basal daily insulin requirements
To assess the effect on basal insulin requirements after switching to AHCL therapy with tighter glycemic objective.
Measured: 3 months
Bolus daily insulin requirements
To assess the effect on insulin bolus requirements after switching to AHCL therapy with tighter glycemic objective.
Measured: 3 months
Time in Tight Range (TTIR 70-140 mg/dL) differences
Percentage differences in time in tight range (TIR 70-140 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.
Measured: 3 months
Time Above Range 1 (TAR-1 >180 mg/dL) differences
Percentage differences in Time Above Range 1 (TAR-1 >180 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.
Measured: 3 months
Time Above Range 2 (TAR-2 >250 mg/dL) differences
Percentage differences in Time Above Range 2 (TAR-2 >250 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.
Measured: 3 months
Time Below Range 1 (TBR-1 <70 mg/dL) differences
Time and percentage differences in Time Below Range 1 (TBR-1 <70 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.
Measured: 3 months
Time Below Range 2 (TBR-2 <54 mg/dL) differences
Time and percentage differences in Time Below Range 2 (TBR-2 <54 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.
Measured: 3 months
Episodes of hyperglycemia level 1 (nº of episodes >180 mg/dL).
Episodes of hyperglycemia level 1 (nº of episodes >180 mg/dL) after switching to aHCL with stringent glycemic control targets.
Measured: 3 months
Episodes of hyperglycemia level 2 (nº of episodes >250 mg/dL).
Episodes of hyperglycemia level 2 (nº of episodes >250 mg/dL) after switching to AHCL with stringent glycemic control targets.
Measured: 3 months
Episodes of hypoglycemia level 1 (nº of episodes <70 mg/dL).
Episodes of hypoglycemia level 1 (nº of episodes <70 mg/dL) after switching to AHCL with stringent glycemic control targets.
Measured: 3 months
Episodes of hypoglycemia level 2 (nº of episodes <54 mg/dL).
Episodes of hypoglycemia level 2 (nº of episodes <54 mg/dL) after switching to AHCL with stringent glycemic control targets.
Measured: 3 months
Nocturnal episodes of hypoglycemia
Nocturnal episodes of hypoglycemia (nº of episodes <70 and <54 mg/dL) after switching to AHCL with stringent glycemic control targets.
Measured: 3 months
Glycemic variability
Glycemic variability (measured throught percentage of the coefficient of variation, CV) differences after switching to AHCL with stringent glycemic control targets.
Measured: 3 months
Mean interstitial glucose
Mean interstitial glucose differences after switching to AHCL with stringent glycemic control targets.
Measured: 3 months
Glucose management indicator (GMI)
Glucose management indicator (GMI) differences after switching to AHCL with stringent glycemic control targets.
Measured: 3 months
Acute complications and mortality
Analyzing the impact of the switch on the frequency of acute complications and mortality due to T1D: severe hypoglycemia, non-acidotic ketotic hyperglycemia, diabetic ketoacidosis, hospital admissions and deaths.
Measured: 3 months
Differences in the Percetage of patients fullfilling the International Consensus of Time in Range
Differences in the Percetage of patients fullfilling the International Consensus of Time in Range (TAR2 <5%, TAR1 <25%, TIR >70%, TBR1 <4%, TBR2 <1%, CV>36%).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start15 Jun 2024
- Primary completion15 Dec 2025
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 1 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Castilla-La Mancha Health Service
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466967
- Sponsor's protocol ID
- CI-712
- Acronym
- TightT1AHCL
- Status last verified
- Mar 2026
- First submitted
- 14 Jun 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: According to the requested data.
Publications
Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.
PubMed 31177185Bally L, Thabit H, Kojzar H, Mader JK, Qerimi-Hyseni J, Hartnell S, Tauschmann M, Allen JM, Wilinska ME, Pieber TR, Evans ML, Hovorka R. Day-and-night glycaemic control with closed-loop insulin delivery versus conventional insulin pump therapy in free-living adults with well controlled type 1 diabetes: an open-label, randomised, crossover study. Lancet Diabetes Endocrinol. 2017 Apr;5(4):261-270. doi: 10.1016/S2213-8587(17)30001-3. Epub 2017 Jan 14.
PubMed 28094136Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; iDCL Trial Research Group. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16.
PubMed 31618560Bergenstal RM, Nimri R, Beck RW, Criego A, Laffel L, Schatz D, Battelino T, Danne T, Weinzimer SA, Sibayan J, Johnson ML, Bailey RJ, Calhoun P, Carlson A, Isganaitis E, Bello R, Albanese-O'Neill A, Dovc K, Biester T, Weyman K, Hood K, Phillip M; FLAIR Study Group. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Lancet. 2021 Jan 16;397(10270):208-219. doi: 10.1016/S0140-6736(20)32514-9.
PubMed 33453783Beato-Vibora PI, Chico A, Moreno-Fernandez J, Bellido-Castaneda V, Nattero-Chavez L, Picon-Cesar MJ, Martinez-Brocca MA, Gimenez-Alvarez M, Aguilera-Hurtado E, Climent-Biescas E, Azriel-Mir S, Rebollo-Roman A, Yoldi-Vergara C, Pazos-Couselo M, Alonso-Carril N, Quiros C. A Multicenter Prospective Evaluation of the Benefits of Two Advanced Hybrid Closed-Loop Systems in Glucose Control and Patient-Reported Outcomes in a Real-world Setting. Diabetes Care. 2024 Feb 1;47(2):216-224. doi: 10.2337/dc23-1355.
PubMed 37948469El Malahi A, Van Elsen M, Charleer S, Dirinck E, Ledeganck K, Keymeulen B, Crenier L, Radermecker R, Taes Y, Vercammen C, Nobels F, Mathieu C, Gillard P, De Block C. Relationship Between Time in Range, Glycemic Variability, HbA1c, and Complications in Adults With Type 1 Diabetes Mellitus. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e570-e581. doi: 10.1210/clinem/dgab688.
PubMed 34534297
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of a Tight Glucose Objectives Through Advanced Hybrid Closed-loop Systems in Adult Patients With Type 1 Diabetes and Poor Glycemic Control
- ClinicalTrials.gov ID
- NCT06466967
- Acronym / sponsor ID
- TightT1AHCL / CI-712
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, advanced hybrid closed-loop, tight time in range, artificial pancreas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Castilla-La Mancha Health ServiceUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 20 Jun 2024 (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.
Diabetes is a chronic disease with a relevant public health burden. Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications. Therefore, the key to prevent and/or reduce the development of these chronic complications lies in an adequate and strict glycemic control.
This study consist of a prospective analytical clinical study in patients with type 1 diabetes (T1D). The main objective is to analyze the effect on time in range (TIR, 70-180 mg/dL) of interstitial glucose after switching to a tighter glucose objective in advanced hybrid closed-loop (AHCL) treated adult T1D patients previously treated with multiple dose insulin injection (MDI) or other AHCL systems without tighter glucose objective function.
Detailed description
Diabetes is a chronic disease with a relevant public health burden. T1D is characterized by the autoimmune destruction of insulin-producing pancreatic beta cells, which requires the administration of exogenous insulin for its treatment. Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications that affect quality of life, as well as morbidity and mortality due to the deleterious long-term effects of suboptimal control. Therefore, the key to prevent and/or reduce the development of these complications lies in adequate and strict glycemic control.
On the one hand, the use of advanced hybrid closed-loop (AHCL) systems in patients with T1D is associated with improved glycemic control and quality of life in both controlled clinical trials and real-life studies. Since 2021, AHCL systems are considered the standard of care, ahead of traditional MDI. On the other hand, among the adjustment parameters of these systems, each AHCL offers different target levels of glycemic control. There is previous evidence that correlates the use of the more intense modes offered by each of the systems with substantial increases in TIR, improvement in the other glycometric variables, as well as the development of acute or chronic complications. In this regard, a new AHCL system has recently been introduced in Spain: CamAPS FX. It is the first AHCL system with the availability of setting lycemic control targets below the traditional 100 mg/dL limit. This system allows glycemic objective as low as 80 mg/dL.
However, there is no information on the benefits and safety of using tighter control targets. The main objective of this study is to analyze the effect on TIR after switching to a tighter glucose objective throught AHCL among adult T1D patients previously treated with MDI or other AHCL systems without this feature.
This is monocenter prospective analytical clinical study (non-randomized). The target population will be adult T1D patients not meeting glycemic control goals followed in Ciudad Real General University Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes patients treated with AHCL (CamAPS-Ypsopump) | – | Device: Advanced hybrid closed-loop CamAPS FXPatients with type 1 diabetes on treatment with AHCL (CamAPS-Ypsopump) and a strict programmed glucose target (80-99 mg/dL). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with type 1 diabetes and poor prior glycemic control, regardless previous treatment, attended in the Public Health System of Castilla-La Mancha in the Health Area of the Ciudad Real General University Hospital
Key inclusion criteria (4 listed)
- Patients with type 1 diabetes.
- Age greater than or equal to 18 years.
- HbA1c > 7% (previous poor glycemic control condition).
- Prior treatment with MDI or aHCL.
Key exclusion criteria (6 listed)
- Other types of diabetes.
- Pregnancy or pre-conception control.
- Uncontrolled psychiatric disease.
- Current or previous treatment with CamAPS-Ypsopump.
- No glucometric data available during the periods under study.
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 |
|---|---|---|
| Advanced hybrid closed-loop CamAPS FXAlso: Ypsopump, CamAPS FXTreatment with a strict programmed glucose target (80-99 mg/dL). | Device | Type 1 diabetes patients treated with AHCL (CamAPS-Ypsopump) |
Primary outcome
Time in Range (TIR) differences
Time frame: 3 months
Percentage differences in time in range (TIR, 70-180 mg/dL) of interstitial glucose after switching to AHCL with tighter glycemic control targets.
23 secondary outcomes
Time in Range (TIR) differencies among therapies
Time frame: 3 months
Differences between stringent glucose control targets
Time frame: 3 months
HbA1c differences
Time frame: 3 months
Usage of AHCL system
Time frame: 3 months
MCG adherence
Time frame: 3 months
Total daily insulin requirements
Time frame: 3 months
Basal daily insulin requirements
Time frame: 3 months
Bolus daily insulin requirements
Time frame: 3 months
Time in Tight Range (TTIR 70-140 mg/dL) differences
Time frame: 3 months
Time Above Range 1 (TAR-1 >180 mg/dL) differences
Time frame: 3 months
Time Above Range 2 (TAR-2 >250 mg/dL) differences
Time frame: 3 months
Time Below Range 1 (TBR-1 <70 mg/dL) differences
Time frame: 3 months
Time Below Range 2 (TBR-2 <54 mg/dL) differences
Time frame: 3 months
Episodes of hyperglycemia level 1 (nº of episodes >180 mg/dL).
Time frame: 3 months
Episodes of hyperglycemia level 2 (nº of episodes >250 mg/dL).
Time frame: 3 months
Episodes of hypoglycemia level 1 (nº of episodes <70 mg/dL).
Time frame: 3 months
Episodes of hypoglycemia level 2 (nº of episodes <54 mg/dL).
Time frame: 3 months
Nocturnal episodes of hypoglycemia
Time frame: 3 months
Glycemic variability
Time frame: 3 months
Mean interstitial glucose
Time frame: 3 months
Glucose management indicator (GMI)
Time frame: 3 months
Acute complications and mortality
Time frame: 3 months
Differences in the Percetage of patients fullfilling the International Consensus of Time in Range
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 31177185Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.
- Background: PubMed 28094136Bally L, Thabit H, Kojzar H, Mader JK, Qerimi-Hyseni J, Hartnell S, Tauschmann M, Allen JM, Wilinska ME, Pieber TR, Evans ML, Hovorka R. Day-and-night glycaemic control with closed-loop insulin delivery versus conventional insulin pump therapy in free-living adults with well controlled type 1 diabetes: an open-label, randomised, crossover study. Lancet Diabetes Endocrinol. 2017 Apr;5(4):261-270. doi: 10.1016/S2213-8587(17)30001-3. Epub 2017 Jan 14.
- Background: PubMed 31618560Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; iDCL Trial Research Group. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16.
- Background: PubMed 33453783Bergenstal RM, Nimri R, Beck RW, Criego A, Laffel L, Schatz D, Battelino T, Danne T, Weinzimer SA, Sibayan J, Johnson ML, Bailey RJ, Calhoun P, Carlson A, Isganaitis E, Bello R, Albanese-O'Neill A, Dovc K, Biester T, Weyman K, Hood K, Phillip M; FLAIR Study Group. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Lancet. 2021 Jan 16;397(10270):208-219. doi: 10.1016/S0140-6736(20)32514-9.
- Background: PubMed 37948469Beato-Vibora PI, Chico A, Moreno-Fernandez J, Bellido-Castaneda V, Nattero-Chavez L, Picon-Cesar MJ, Martinez-Brocca MA, Gimenez-Alvarez M, Aguilera-Hurtado E, Climent-Biescas E, Azriel-Mir S, Rebollo-Roman A, Yoldi-Vergara C, Pazos-Couselo M, Alonso-Carril N, Quiros C. A Multicenter Prospective Evaluation of the Benefits of Two Advanced Hybrid Closed-Loop Systems in Glucose Control and Patient-Reported Outcomes in a Real-world Setting. Diabetes Care. 2024 Feb 1;47(2):216-224. doi: 10.2337/dc23-1355.
- Background: PubMed 34534297El Malahi A, Van Elsen M, Charleer S, Dirinck E, Ledeganck K, Keymeulen B, Crenier L, Radermecker R, Taes Y, Vercammen C, Nobels F, Mathieu C, Gillard P, De Block C. Relationship Between Time in Range, Glycemic Variability, HbA1c, and Complications in Adults With Type 1 Diabetes Mellitus. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e570-e581. doi: 10.1210/clinem/dgab688.
- Individual participant dataSharing planned: Undecided. According to the requested data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Castilla-La Mancha Health Service at 1 site in Spain.
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: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Range (TIR) differences (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06466967, which also lists 6 linked publications.
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 19 Mar 2026.