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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 : Recruiting
First Posted : January 4, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
University of Castilla-La Mancha
Universidad de Córdoba
Information provided by (Responsible Party):
Jesús Moreno Fernández, Castilla-La Mancha Health Service

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.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus 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.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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 Name: 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 Name: MDI




Primary Outcome Measures :
  1. Concentration of Hemoglobin A1C (HbA1C). [ Time Frame: 1 year ]
    Between group hemoglobin A1C (HbA1C) difference. Physiological parameter. Unit of measure: %.


Secondary Outcome Measures :
  1. Hypoglycemia frequency. [ Time Frame: 1 year ]
    Between group hypoglycemic frequency difference. Unit of measure: daily number of events of glycemic values <70 mg/dL.

  2. Concentration of Capillary blood glucose. [ Time Frame: 1 year ]
    Between group capillary blood glucose difference. Physiological parameter. Unit of measure: mg/dL.

  3. Concentration of Interstitial blood glucose. [ Time Frame: 1 year ]
    Between group interstitial blood glucose difference. Physiological parameter. Unit of measure: mg/dL.

  4. 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: %.


  5. 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.


  6. 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.

  7. 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.


  8. Weight. [ Time Frame: 1 year ]
    Between group weight differences. Physiological parameter. Unit of measure: Kg.

  9. Insuline dose. [ Time Frame: 1 year ]
    Daily insulin doses (basal and bolus) and bolus insulin daily frequency. Unit of measure: IU/Kg/24h.

  10. 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.


  11. 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).


  12. 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).

  13. Safety related adverse events. [ Time Frame: 1 year ]
    Serious related adverse events: diabetes ketoacidosis, hospitalization, death. Unit of measure: number of events.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793283


Contacts
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Contact: Jesus Moreno-Fernandez, PhD 926278000 ext 79509 jmorenof@sescam.jccm.es
Contact: Angela M Seco Segura, RN 926278000 ext 79510 amsese@live.com

Locations
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Spain
Obispo Rafael Torija, St. Recruiting
Ciudad Real, Spain, 13005
Contact: Jesus Moreno-Fernandez, MD, PhD    926278000 ext 79509    jmorenof@sescam.jccm.es   
Sub-Investigator: Miriam Herrera Moraleda         
Sub-Investigator: Jose Alberto Garcia-Seco, RN         
Sub-Investigator: Fernando Garcia-Seco, MD         
Sponsors and Collaborators
Castilla-La Mancha Health Service
University of Castilla-La Mancha
Universidad de Córdoba
Investigators
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Principal Investigator: Jesus Moreno-Fernandez, PhD Castilla-La Mancha Public Health Service.

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Responsible Party: Jesús Moreno Fernández, Principal investigator, Castilla-La Mancha Health Service
ClinicalTrials.gov Identifier: NCT03793283     History of Changes
Other Study ID Numbers: C-225
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs