An observational study in Type 1 Diabetes Mellitus, sponsored by Castilla-La Mancha Health Service. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Castilla-La Mancha Health Service · Observational
Observational study about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice.
Cross-sectional analysis about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in T1DM adult patients in routine clinical practice.
All clinical variables are gathered from four EMR softwares (Mambrino XXI, Carelink Pro®, Emminens eConecta® and FreeStyle Libre®).
Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \< 0.05 was considered statistically significant.
The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 90 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Castilla-La Mancha Health Service is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Forty-five T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII.
MDI patients will be selected through simple random sampling (1:1) from our T1DM patient database.
Exclusion Criteria:
All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII. Forty-five patients are actually treated with CSII in our hospital.
Device: CSII
Forty-five T1DM adult patients attended in Ciudad Real General University Hospital and treated with MDI. MDI patients will be selected through simple random sampling (1:1) from our T1DM patient database.
Drug: Multiple dose insulin injections
Currently receiving CSII therapy during 6 or more months.
Also known as: Continuous subcutaneous insulin infusion
Currently receiving MDI therapy during 6 or more months.
Also known as: MDI
Concentration of Hemoglobin A1C (HbA1C).
Between group hemoglobin A1C (HbA1C) difference. Physiological parameter. Unit of measure: %.
Time frame: 1 year
Hypoglycemia frequency.
Between group hypoglycemic frequency difference. Unit of measure: daily number of events of glycemic values \<70 mg/dL.
Time frame: 1 year
Concentration of Capillary blood glucose.
Between group capillary blood glucose difference. Physiological parameter. Unit of measure: mg/dL.
Time frame: 1 year
Concentration of Interstitial blood glucose.
Between group interstitial blood glucose difference. Physiological parameter. Unit of measure: mg/dL.
Time frame: 1 year
Glycemic variability: coefficient of variation of capilary/interstitial blood glucose.
Glycemic variability expressed as coefficient of variation of capilary/interstitial blood glucose. Physiological parameter. Unit of measure: %.
Time frame: 1 year
Glycemic variability: standar deviation of capilary/interstitial blood glucose.
Glycemic variability expressed as standar deviation of capilary/interstitial blood glucose. Physiological parameter. Unit of measure: mg/dL.
Time frame: 1 year
Self-monitoring of blood glucose (SMBG) daily frequency
Self-monitoring of blood glucose (SMBG) daily frequency. Unit of measure: number of daily controls.
Time frame: 1 year
Severe hypoglycemia frequency.
Number of events during the last year of severe hypoglycemia frequency defined as any glycemic value \<70 mg/dL requiring assitance from another person to treat. Unit of measure: number of events during the last 12 months.
Time frame: 1 year
Weight.
Between group weight differences. Physiological parameter. Unit of measure: Kg.
Time frame: 1 year
Insuline dose.
Daily insulin doses (basal and bolus) and bolus insulin daily frequency. Unit of measure: IU/Kg/24h.
Time frame: 1 year
Diabetes quality of life (DQOL).
Diabetes related quality of life (EsDQOL questionnary). Spanihs version of DQOL questionnary. Unit of measure: Questionnary score. Higher values represent a worse outcome. Forty-six questions in four categories: Satisfaction (15), Impact (20), Social/vacational worryness (7) and Diabetes related worryness (4). Each question score from 1 to 5 points. Total minimum score 46, total maximum score 230. Satisfaction range from 15 to 75, Impact range from 20 to 100, Social/vacational worryness range from 7 to 35 and Diabetes related worryness range from 4 to 20.
Time frame: 1 year.
Satisfaction with the treatment received: Diabetes Treatment Satisfaction Questionnaire Stable
Satisfaction with the treatment received (Diabetes Treatment Satisfaction Questionnaire Stable, EsDTSQs questionnary). Spanish version of DTSQs questionnary. Unit of measure: Questionnary score. Higher values represent a better outcome. Eight questions with seven possible answers ranged each one from 0 to 6 points. First six questions compute a subscore ranged from 0 to 36 points. Two last questions are independtly analyzed (each one range from 0 to 6 points).
Time frame: 1 year
Unawareness hypoglycemia.
Unawareness hypoglycemia frequency (Clarke questionnary). Unit of measure: Questionnary score. Higher values represent a worse outcome. Eight questions with each answer categorized in normal (A) or abnormal (R). Total sum of abnormal (R) answers classifed patients in normal perception (range from 0 to 2), indeterminate percepction (range=3) and abnormal perception (range from 4 to 8).
Time frame: 1 year.
Safety related adverse events.
Serious related adverse events: diabetes ketoacidosis, hospitalization, death. Unit of measure: number of events.
Time frame: 1 year
Plan to share: No
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Castilla-La Mancha Health Service