Type 1 Diabetes (T1D)
Conditions
Keywords
Type 1 diabetes, Advanced hybrid closed-loop, Time in tight range, artificial pancreas, Control-IQ, SmartGuard, CamAPS
Brief 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. 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.
Detailed description
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.
Interventions
Sponsors
Castilla-La Mancha Health Service
Servicio Extremeño de Salud (Spain)
Hospital Universitari Mutua Terrassa
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with type 1 diabetes. * Age greater than or equal to 18 years. * Treated with advanced hybrid closed-loop systems (AHCL) for at least 3 months * Actived continuous glucose monitoring data in the last 14 days.
Exclusion criteria
* Other types of diabetes. * Receiving treatment with insulin regimens other than AHCL. * Having received AHCL treatment for less than 3 months in a row prior to inclusion in the study with the same system. * No data on use of the AHCL system during the previous 14 days. * Severe or uncontrolled psychiatric disorder. * Pregnancy or end of pregnancy less than 3 months ago or preparation for pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TiTR | Retrospective data from the last 14 days after study entry | Percentage differences in time in tight range (TiTR, 70-140 mg/dL) of interstitial glucose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TIR | Retrospective data from the last 14 days after study entry | Percentage differences in time in range (TIR, 70-180 mg/dL) of interstitial glucose. |
| TAR1 | Retrospective data from the last 14 days after study entry | Percentage differences in time above range 1 (180-250 mg/dL) of interstitial glucose. |
| TAR2 | Retrospective data from the last 14 days after study entry | Percentage differences in time above range 2 (\>250 mg/dL) of interstitial glucose. |
| TBR1 | Retrospective data from the last 14 days after study entry | Percentage differences in time bellow range 1 (\<70 mg/dL) of interstitial glucose. |
| TBR2 | Retrospective data from the last 14 days after study entry | Percentage differences in time bellow range 2 (\<55 mg/dL) of interstitial glucose. |
| HbA1C | Retrospective data from the last 3 months after study entry | Differences in HbA1C values (%) |
| AHCL use | Retrospective data from the last 14 days after study entry | Percentage differences in time of use of the AHCL system (%) |
| Insulin use | Retrospective data from the last 14 days after study entry | Daily dose of insulin use in AHCL system (UI/day) |
| Coefficient of variation | Retrospective data from the last 14 days after study entry | Percentage differences in the coefficient of variation of interstitial glucose (%) |
| Quality-of-life questionnaire designed for diabetes mellitus (EsDQOL) | Retrospective quality-of-life during the last 3 months | 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). |
| Hypoglycemia Fear Survey (HFS questionnaire) | Retrospective fear to hypoglycemia during the last 3 months | 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). |
| Clarke's questionnaire | Retrospective hypoglycemia awareness during the last 3 months | 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). |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORJesus Moreno Fernandez, PhD
Castilla-La Mancha Health Public Service
Outcome results
None listed