Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Routine Clinical Practice (real-ECIMI)

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: CSII; Drug: Multiple dose insulin injections

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Spain
  • Ciudad Real, Spain, 13005
    • Obispo Rafael Torija, St.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Continous Subcutaneous Insulin Infusion; 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; Currently receiving CSII therapy during 6 or more months.; Other Names: Continuous subcutaneous insulin infusion
Multiple dose insulin injections (MDI): 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 MDI therapy during 6 or more months.; Other Names: MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Hemoglobin A1C (HbA1C).	Between group hemoglobin A1C (HbA1C) difference. Physiological parameter. Unit of measure: %.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoglycemia frequency.	Between group hypoglycemic frequency difference. Unit of measure: daily number of events of glycemic values <70 mg/dL.	1 year
Concentration of Capillary blood glucose.	Between group capillary blood glucose difference. Physiological parameter. Unit of measure: mg/dL.	1 year
Concentration of Interstitial blood glucose.	Between group interstitial blood glucose difference. Physiological parameter. Unit of measure: mg/dL.	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: %.	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.	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.	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.	1 year
Weight.	Between group weight differences. Physiological parameter. Unit of measure: Kg.	1 year
Insuline dose.	Daily insulin doses (basal and bolus) and bolus insulin daily frequency. Unit of measure: IU/Kg/24h.	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.	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).	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).	1 year.
Safety related adverse events.	Serious related adverse events: diabetes ketoacidosis, hospitalization, death. Unit of measure: number of events.	1 year

Collaborators and Investigators

• Sponsor: Castilla-La Mancha Health Service
• Collaborators: Universidad de Córdoba; University of Castilla-La Mancha
• Investigators: Principal Investigator: Jesus Moreno-Fernandez, PhD, Castilla-La Mancha Public Health Service.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: C-225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No