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| Name | Class |
|---|---|
| Servicio Extremeño de Salud (Spain) | UNKNOWN |
| Hospital Mutua de Terrassa | OTHER |
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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 cross-sectional observational study among adult patients with type 1 diabetes (T1D). The main objective is to analyze the effect on time in tight range (TiTR, 70-140 mg/dL) of interstitial glucose between three different advanced hybrid closed-loop (AHCL) systems.
Diabetes is a chronic disease with a relevant public health burden. Type 1 diabetes (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.
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.
There are three main types of AHCL systems marketed in Spain: SmartGuard in Medtronic Minimed 780G (MM780G), Control-IQ in Tandem T Slim X2 (TTSX2) and CamAPS in Ypsopump (CamAPS).
All three systems have been shown indepently to significantly improve glycaemic control in people with DM1 as expressed by the classic control targets of the International Time in Range Consensus (percentage of interstitial glucose time in range 70-180 mg/dL >70%). So much so that it has been suggested to further intensify the possible glucose targets in patients treated with AHCL systems to a time in tight range (TITR) of interstitial glucose (70-140 mg/dL) >50%.
However, there is little information on the benefits and safety of using tighter control targets. Furthermore, there is no evidence about comparing the clinical benefit differences between these three types of technology.
The main objective is to analyze the effect on time in tight range (TiTR, 70-140 mg/dL) of interstitial glucose between three different advanced hybrid closed-loop (AHCL) systems among adult people with T1D.
This is multicenter (3 centers) cross-sectional observational clinical study (non-randomized). The target population will be adult T1D patients treated with any of the aforementioned AHCL systems followed in any of the three participant centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MM780G | Patients with type 1 diabetes treated with Medtronic Minimed 780G hybrid closed-loop systems |
| |
| TTSX2 | Patients with type 1 diabetes treated with Tandem T Slim X2 hybrid closed-loop system |
| |
| CamAPS | Patients with type 1 diabetes treated with CamAPS hybrid closed-loop system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MM780G | Device | SmartGuard in Medtronic Minimed 780G advaced hybrid closed-loop |
|
| Measure | Description | Time Frame |
|---|---|---|
| TiTR | Percentage differences in time in tight range (TiTR, 70-140 mg/dL) of interstitial glucose. | Retrospective data from the last 14 days after study entry |
| Measure | Description | Time Frame |
|---|---|---|
| TIR | Percentage differences in time in range (TIR, 70-180 mg/dL) of interstitial glucose. | Retrospective data from the last 14 days after study entry |
| TAR1 | Percentage differences in time above range 1 (180-250 mg/dL) of interstitial glucose. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%). | Retrospective data from the last 14 days after study entry |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients with type 1 diabetes treated with AHCL attended in any of the three centers.
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| Name | Affiliation | Role |
|---|---|---|
| Jesus Moreno Fernandez, PhD | Castilla-La Mancha Health Public Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Badajoz University Hospital | Badajoz | Badajoz | 06080 | Spain | ||
| Hospital Universitario Mutua de Tarrasa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38078575 | Background | American Diabetes Association Professional Practice Committee. 7. Diabetes Technology: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S126-S144. doi: 10.2337/dc24-S007. | |
| 39298688 | Background | Di Molfetta S, Di Gioia L, Caruso I, Cignarelli A, Green SC, Natale P, Strippoli GFM, Sorice GP, Perrini S, Natalicchio A, Laviola L, Giorgino F. Efficacy and Safety of Different Hybrid Closed Loop Systems for Automated Insulin Delivery in People With Type 1 Diabetes: A Systematic Review and Network Meta-Analysis. Diabetes Metab Res Rev. 2024 Sep;40(6):e3842. doi: 10.1002/dmrr.3842. |
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Under request and after consideration from all investigators.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| TTSX2 | Device | Control-IQ in Tandem T Slim X2 advanced hybrid closed-loop |
|
|
| CamAPS | Device | CamAPS Fx in Ypsopump advanced hybrid closed-loop |
|
|
| Retrospective data from the last 14 days after study entry |
| TAR2 | Percentage differences in time above range 2 (>250 mg/dL) of interstitial glucose. | Retrospective data from the last 14 days after study entry |
| TBR1 | Percentage differences in time bellow range 1 (<70 mg/dL) of interstitial glucose. | Retrospective data from the last 14 days after study entry |
| TBR2 | Percentage differences in time bellow range 2 (<55 mg/dL) of interstitial glucose. | Retrospective data from the last 14 days after study entry |
| HbA1C | Differences in HbA1C values (%) | Retrospective data from the last 3 months after study entry |
| AHCL use | Percentage differences in time of use of the AHCL system (%) | Retrospective data from the last 14 days after study entry |
| Insulin use | Daily dose of insulin use in AHCL system (UI/day) | Retrospective data from the last 14 days after study entry |
| Coefficient of variation | Percentage differences in the coefficient of variation of interstitial glucose (%) | Retrospective data from the last 14 days after study entry |
| Quality-of-life questionnaire designed for diabetes mellitus (EsDQOL) | Assessing the perceived quality of life according to the EsDQOL questionnaire (with values between 46 and a maximum of 230, the higher the score the poorer the satisfaction with ACHL treatment). | Retrospective quality-of-life during the last 3 months |
| Hypoglycemia Fear Survey (HFS questionnaire) | Assessing the fear of hypoglycemia according to the HFS questionnaire (with values between 24 points and a maximum of 120 points, the higher the score the higher the fear of hypoglycemia). | Retrospective fear to hypoglycemia during the last 3 months |
| Clarke's questionnaire | Assessing the awareness of hypoglycemia according to Clarke's questionnaire (with values between 0 and 8 points, a score equal or greater than four indicates hypoglycemia unawareness). | Retrospective hypoglycemia awareness during the last 3 months |
| Terrassa |
| Barcelona |
| 08221 |
| Spain |
| Ciudad Real General University Hospital | Ciudad Real | Ciudad Real | 13005 | Spain |
| 37067353 | Background | Beck RW, Kanapka LG, Breton MD, Brown SA, Wadwa RP, Buckingham BA, Kollman C, Kovatchev B. A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72. Diabetes Technol Ther. 2023 May;25(5):329-342. doi: 10.1089/dia.2022.0558. Epub 2023 Apr 12. |
| 38113453 | Background | Castaneda J, Arrieta A, van den Heuvel T, Battelino T, Cohen O. Time in Tight Glucose Range in Type 1 Diabetes: Predictive Factors and Achievable Targets in Real-World Users of the MiniMed 780G System. Diabetes Care. 2024 May 1;47(5):790-797. doi: 10.2337/dc23-1581. |
| 37870460 | Background | Beck RW, Raghinaru D, Calhoun P, Bergenstal RM. A Comparison of Continuous Glucose Monitoring-Measured Time-in-Range 70-180 mg/dL Versus Time-in-Tight-Range 70-140 mg/dL. Diabetes Technol Ther. 2024 Mar;26(3):151-155. doi: 10.1089/dia.2023.0380. Epub 2023 Oct 13. |
| 37948469 | Background | Beato-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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |