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This is a prospective, non-randomized, observational cohort study conducted in adult patients with type 1 diabetes.Participants with poorly controlled T1D under multiple daily injection (MDI) treatment will be assigned to one of three treatment groups:
Patients with type 1 diabetes mellitus (T1DM) present subclinical signs of vascular and endothelial dysfunction earlier compared to healthy individuals. Hybrid closed loop systems (HCLS) are currently the gold standard method for glycemic management, however, the data regarding its superiority in terms of the prevention of subclinical vascular and endothelial dysfunction are scarce. The aim of this study is to determine whether treatment with HCLS improves vascular and endothelial function compared to multiple daily injections (MDI) or Sodium glucose co-transporter 2 inhibitors (SGLT-2i) in patients with T1DM. Partcipants with poorly controlled T1DM under MDI treatment, will be assigned to receive either:
We will assess at baseline and 6 and 12 months post-treatment:
(i) glycemic parameters derived via continuous glucose monitoring (GGM) (ii) pulse wave velocity (PWV) (iii)central systolic and diastolic blood pressure (cSBP, cDBP) (iv) the perfused boundary region (PBR) of the sublingual arterial microvessels, as a marker of endothelial glycocalyx integrity.
(v) global longitudinal strain(GLS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCL group | Patients will recieve hybrid closed loop system |
| |
| SGLT-2i group | Patients will recieve SGLT-2i as add on treatment to multiple daily injections |
| |
| MDI group | Patients will recieve intensification of MDI treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCLS | Device | Hybrid Closed-Loop System treatment |
| |
| SGLT2 inhibitor |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Wave Velocity | The investigators will assess pulse wave velocity as a marker of arterial stiffness at baseline, at six and twelve months post-treatment | Baseline, Six Months, Twelve months |
| Perfused Boundary Region | The investigators will assess perfused boundary region as a marker of endothelial glycocalyx integrity at baseline, at six and twelve months post-treatment | Baseline, Six Months, Twelve months |
| Global Longitudinal Strain | The investigators will assess global londitudinal strain as a marker of myocardial function at baseline, at six and twelve months post-treatment | Baseline, Six Months, Twelve months |
| Measure | Description | Time Frame |
|---|---|---|
| Central Systolic Blood Pressure | The investigators will assess central systolic blood pressure as a marker of vascular function at baseline, at six and twelve months post-treatment | Baseline, Six Months, Twelve months |
| Central Diastolic Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with poorly controlled type 1 diabetes
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Attikon University General Hospital | Athens | 12462 | Greece |
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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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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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| Drug |
SGLT-2 Inhibitor Treatment |
|
| MDI | Drug | Multiple Daily Injection Insulin treatment |
|
The investigators will assess central diastolic blood pressure as a marker of vascular function at baseline, at six and twelve months post-treatment |
| Baseline, Six Months, Twelve months |
| Augmentation Index | The investigators will assess Augmentation Index as a marker of vascular function at baseline, at six and twelve months post-treatment | Baseline, Six Months, Twelve months |
| Flow mediated dilation | The investigators will assess Flow Mediated Dilation as a marker of endothelial function at baseline, at six and twelve months post-treatment | Baseline, Six Months, Twelve months |
| Coronary flow reserve | The investigators will assess Coronary flow reserve at baseline, at six and twelve months post-treatment | Baseline, Six Months, Twelve months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D045505 | Physiological Effects of Drugs |