Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Routine Clinical Practice

Type 1 Diabetes Mellitus Clinical Trial

— real-ECIMI  

Official title:

Effectiveness and Safety of Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Type 1 Diabetes Mellitus Adult Patients in Routine Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793283
• Other study ID #: C-225
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Castilla-La Mancha Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years of age.

• Diagnosed of Type 1 Diabetes Mellitus.

• Be attended in Ciudad Real General University Hospital.

• Current treated with CSII (CSII cohort) or MDI (MDI cohort) during =6 months.

Exclusion Criteria:

• Less than 18 years old.

• Other types of diabetes mellitus.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• CSII
Currently receiving CSII therapy during 6 or more months.

Drug:
• Multiple dose insulin injections
Currently receiving MDI therapy during 6 or more months.

Locations

Country	Name	City	State
Spain	Obispo Rafael Torija, St.	Ciudad Real

Sponsors (3)

Lead Sponsor	Collaborator
Castilla-La Mancha Health Service	Universidad de Córdoba, University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Hemoglobin A1C (HbA1C).	Between group hemoglobin A1C (HbA1C) difference. Physiological parameter. Unit of measure: %.	1 year
Secondary	Hypoglycemia frequency.	Between group hypoglycemic frequency difference. Unit of measure: daily number of events of glycemic values <70 mg/dL.	1 year
Secondary	Concentration of Capillary blood glucose.	Between group capillary blood glucose difference. Physiological parameter. Unit of measure: mg/dL.	1 year
Secondary	Concentration of Interstitial blood glucose.	Between group interstitial blood glucose difference. Physiological parameter. Unit of measure: mg/dL.	1 year
Secondary	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: %.	1 year
Secondary	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.	1 year
Secondary	Self-monitoring of blood glucose (SMBG) daily frequency	Self-monitoring of blood glucose (SMBG) daily frequency. Unit of measure: number of daily controls.	1 year
Secondary	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.	1 year
Secondary	Weight.	Between group weight differences. Physiological parameter. Unit of measure: Kg.	1 year
Secondary	Insuline dose.	Daily insulin doses (basal and bolus) and bolus insulin daily frequency. Unit of measure: IU/Kg/24h.	1 year
Secondary	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.	1 year.
Secondary	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).	1 year
Secondary	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).	1 year.
Secondary	Safety related adverse events.	Serious related adverse events: diabetes ketoacidosis, hospitalization, death. Unit of measure: number of events.	1 year