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Completed

NCT Number: NCT03793283

Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections 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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Obispo Rafael Torija, St.

Ciudad Real, 13005, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CSII

Device

Currently receiving CSII therapy during 6 or more months.

Other names: Continuous subcutaneous insulin infusion

Multiple dose insulin injections

Drug

Currently receiving MDI therapy during 6 or more months.

Other names: MDI

Primary outcomes

  1. Concentration of Hemoglobin A1C (HbA1C).

    Time frame: 1 year

    Between group hemoglobin A1C (HbA1C) difference. Physiological parameter. Unit of measure: %.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Castilla-La Mancha Health Service

Other

Collaborators

  • Universidad de Córdoba
  • University of Castilla-La Mancha

Registry information

Official study 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

Acronym: real-ECIMI

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 4, 2019
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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