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

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ClinicalTrials.gov Identifier: NCT03793283
Recruitment Status : Not yet recruiting
First Posted : January 4, 2019
Last Update Posted : January 7, 2019
Sponsor:
Collaborators:
University of Castilla-La Mancha
Universidad de Córdoba
Information provided by (Responsible Party):
Jesús Moreno Fernández, Castilla-La Mancha Health Service

Tracking Information
First Submitted Date December 27, 2018
First Posted Date January 4, 2019
Last Update Posted Date January 7, 2019
Estimated Study Start Date January 1, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 4, 2019)
Concentration of Hemoglobin A1C (HbA1C). [ Time Frame: 1 year ]
Between group hemoglobin A1C (HbA1C) difference. Physiological parameter. Unit of measure: %.
Original Primary Outcome Measures
 (submitted: January 3, 2019)
Hemoglobin A1C (HbA1C). [ Time Frame: 1 year ]
Between group hemoglobin A1C (HbA1C) difference. Physiological parameter. Unit of measure: %.
Change History Complete list of historical versions of study NCT03793283 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 4, 2019)
  • Hypoglycemia frequency. [ Time Frame: 1 year ]
    Between group hypoglycemic frequency difference. Unit of measure: daily number of events of glycemic values <70 mg/dL.
  • Concentration of Capillary blood glucose. [ Time Frame: 1 year ]
    Between group capillary blood glucose difference. Physiological parameter. Unit of measure: mg/dL.
  • Concentration of Interstitial blood glucose. [ Time Frame: 1 year ]
    Between group interstitial blood glucose difference. Physiological parameter. Unit of measure: mg/dL.
  • Glycemic variability: coefficient of variation of capilary/interstitial blood glucose. [ Time Frame: 1 year ]
    Glycemic variability expressed as coefficient of variation of capilary/interstitial blood glucose. Physiological parameter. Unit of measure: %.
  • Glycemic variability: standar deviation of capilary/interstitial blood glucose. [ Time Frame: 1 year ]
    Glycemic variability expressed as standar deviation of capilary/interstitial blood glucose. Physiological parameter. Unit of measure: mg/dL.
  • Self-monitoring of blood glucose (SMBG) daily frequency [ Time Frame: 1 year ]
    Self-monitoring of blood glucose (SMBG) daily frequency. Unit of measure: number of daily controls.
  • Severe hypoglycemia frequency. [ Time Frame: 1 year ]
    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.
  • Weight. [ Time Frame: 1 year ]
    Between group weight differences. Physiological parameter. Unit of measure: Kg.
  • Insuline dose. [ Time Frame: 1 year ]
    Daily insulin doses (basal and bolus) and bolus insulin daily frequency. Unit of measure: IU/Kg/24h.
  • Diabetes quality of life (DQOL). [ Time Frame: 1 year. ]
    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.
  • Satisfaction with the treatment received: Diabetes Treatment Satisfaction Questionnaire Stable [ Time Frame: 1 year ]
    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).
  • Unawareness hypoglycemia. [ Time Frame: 1 year. ]
    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).
  • Safety related adverse events. [ Time Frame: 1 year ]
    Serious related adverse events: diabetes ketoacidosis, hospitalization, death. Unit of measure: number of events.
Original Secondary Outcome Measures
 (submitted: January 3, 2019)
  • Hypoglycemia frequency. [ Time Frame: 1 year ]
    Between group hypoglycemic frequency difference. Unit of measure: daily number of events of glycemic values <70 mg/dL.
  • Capillary blood glucose. [ Time Frame: 1 year ]
    Capillary blood glucose. Physiological parameter. Unit of measure: mg/dL.
  • Interstitial blood glucose. [ Time Frame: 1 year ]
    Interstitial blood glucose. Physiological parameter. Unit of measure: mg/dL.
  • Glycemic variability: coefficient of variation of capilary/interstitial blood glucose. [ Time Frame: 1 year ]
    Glycemic variability expressed as coefficient of variation of capilary/interstitial blood glucose. Physiological parameter. Unit of measure: %.
  • Glycemic variability: standar deviation of capilary/interstitial blood glucose. [ Time Frame: 1 year ]
    Glycemic variability expressed as standar deviation of capilary/interstitial blood glucose. Physiological parameter. Unit of measure: mg/dL.
  • Self-monitoring of blood glucose (SMBG) daily frequency [ Time Frame: 1 year ]
    Self-monitoring of blood glucose (SMBG) daily frequency. Unit of measure: number of daily controls.
  • Severe hypoglycemia frequency. [ Time Frame: 1 year ]
    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.
  • Weight. [ Time Frame: 1 year ]
    Between group weight differences. Physiological parameter. Unit of measure: Kg.
  • Insuline dose. [ Time Frame: 1 year ]
    Daily insulin doses (basal and bolus) and bolus insulin daily frequency. Unit of measure: IU/Kg/24h.
  • Diabetes quality of life (DQOL). [ Time Frame: 1 year. ]
    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.
  • Satisfaction with the treatment received: Diabetes Treatment Satisfaction Questionnaire Stable [ Time Frame: 1 year ]
    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).
  • Unawareness hypoglycemia. [ Time Frame: 1 year. ]
    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).
  • Safety related adverse events. [ Time Frame: 1 year ]
    Serious related adverse events: diabetes ketoacidosis, hospitalization, death. Unit of measure: number of events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Routine Clinical Practice
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
Brief 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.
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
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Type 1 Diabetes Mellitus
Intervention
  • Device: CSII
    Currently receiving CSII therapy during 6 or more months.
    Other Name: Continuous subcutaneous insulin infusion
  • Drug: Multiple dose insulin injections
    Currently receiving MDI therapy during 6 or more months.
    Other Name: MDI
Study Groups/Cohorts
  • 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.

    Intervention: Device: CSII
  • 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.

    Intervention: Drug: Multiple dose insulin injections
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 3, 2019)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jesus Moreno-Fernandez, PhD 926278000 ext 79509 jmorenof@sescam.jccm.es
Contact: Angela M Seco Segura, RN 926278000 ext 79510 amsese@live.com
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03793283
Other Study ID Numbers C-225
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jesús Moreno Fernández, Castilla-La Mancha Health Service
Study Sponsor Castilla-La Mancha Health Service
Collaborators
  • University of Castilla-La Mancha
  • Universidad de Córdoba
Investigators
Principal Investigator: Jesus Moreno-Fernandez, PhD Castilla-La Mancha Public Health Service.
PRS Account Castilla-La Mancha Health Service
Verification Date January 2019