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Clinical Trial Details

Trial ID: L4497
Source ID: NCT04739241
Associated Drug: Premixed Insulin Therapy
Title: Premixed vs Basal Bolus Insulin Therapy in Older Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Treated With Insulin
Interventions: DRUG: premixed insulin therapy|DRUG: basal bolus insulin therapy
Outcome Measures: Primary: Change in HbA1c levels, Change from baseline in HbA1c levels after 12 months of therapy, 12 months after recruitment | Secondary: Incidence of hypoglycaemia as an adverse effect of the treatment, Number of hypoglycaemias by month, every month during the 12-month follow-up|Incidence of dosing errors as a measure of the safety of the treatment, Number of dosing errors by month, every month during the 12-month follow-up|Change in the scores of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) from recruitment to month 12., Change from baseline to12 months of therapy using the DTSQ questionnaire of satisfactions with the treatment of diabetes., 12-month follow-up|Change in the scores of the Diabetes Quality Of Life Questionnaire (EsDQOL) from recruitment to month 12., Change from baseline to12 months of therapy using the EsDQOL questionnaire of quality of life in diabetic patients, 12-month follow-up
Sponsor/Collaborators: Sponsor: Consorci Sanitari Integral
Gender: ALL
Age: OLDER_ADULT
Phases: PHASE4
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-01-24
Completion Date: 2018-06-19
Results First Posted:
Last Update Posted: 2021-02-04
Locations:
URL: https://clinicaltrials.gov/show/NCT04739241