Clinical Utility of Tight Objectives of Advanced Hybrid Closed-loop Systems Among Type 1 Diabetes Patients (TightT1AHCL)
Recruiting
- Conditions
- Type 1 Diabetes
- Registration Number
- NCT06466967
- Lead Sponsor
- Castilla-La Mancha Health Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> - Patients with type 1 diabetes.<br><br> - Age greater than or equal to 18 years.<br><br> - HbA1c > 7% (previous poor glycemic control condition).<br><br> - Prior treatment with MDI or aHCL.<br><br>Exclusion Criteria:<br><br> - Other types of diabetes.<br><br> - Pregnancy or pre-conception control.<br><br> - Uncontrolled psychiatric disease.<br><br> - Current or previous treatment with CamAPS-Ypsopump.<br><br> - No glucometric data available during the periods under study.<br><br> - History of severe hypoglycemia.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational [Patient Registry]
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time in Range (TIR) differences
- Secondary Outcome Measures
Name Time Method Time in Range (TIR) differencies among therapies;Differences between stringent glucose control targets;HbA1c differences;Usage of AHCL system;MCG adherence;Total daily insulin requirements;Basal daily insulin requirements;Bolus daily insulin requirements;Time in Tight Range (TTIR 70-140 mg/dL) differences;Time Above Range 1 (TAR-1 >180 mg/dL) differences;Time Above Range 2 (TAR-2 >250 mg/dL) differences;Time Below Range 1 (TBR-1 <70 mg/dL) differences;Time Below Range 2 (TBR-2 <54 mg/dL) differences;Episodes of hyperglycemia level 1 (nº of episodes >180 mg/dL).;Episodes of hyperglycemia level 2 (nº of episodes >250 mg/dL).;Episodes of hypoglycemia level 1 (nº of episodes <70 mg/dL).;Episodes of hypoglycemia level 2 (nº of episodes <54 mg/dL).;Nocturnal episodes of hypoglycemia;Glycemic variability;Mean interstitial glucose;Glucose management indicator (GMI);Acute complications and mortality;Differences in the Percetage of patients fullfilling the International Consensus of Time in Range