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Completed

NCT Number: NCT04761094

Clinical Efficacy of Insulin Pumps in Type 1 Diabetes Mellitus Patients in Spain

Observational cross-sectional multicenter study about clinical efficacy of insulin pumps in type 1 diabetes mellitus patients.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, Spain

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About this study

Observational cross-sectional multicenter study about clinical efficacy of continuous subcutaneous insulin infusion in type 1 diabetes mellitus patients.

All clinical variables are gathered from the Spanish Insulin Pump National Registry.

Data analysis is conducted using SPSS (Chicago, IL) statistic software. Results are presented as mean +/- SD values. 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

  • Type 1 diabetes patients treated with insulin pump.
  • Medical treatment received in Spain.

Exclusion criteria

  • Any other kinds of diabetes.

Treatment and study plan

Insulin pump

Device

Treatment with continuous subcutaneous insulin infusion

Primary outcomes

  1. HbA1C

    Time frame: During the procedure

    Glycated haemoglobin A1C

Secondary outcomes

  1. TIR

    Time frame: During the procedure

    Time in range (TIR, 3.9-10 mmol/L, 70-180 mg/dL) of the interstitial glucose

  2. TAR

    Time frame: During the procedure

    Time above range (TAR, >10 mmol/L, >180 mg/dL) of the interstitial glucose

  3. TUR

    Time frame: During the procedure

    Time under range (TUR, <3.9 mmol/L, <70 mg/dL) of the interstitial glucose

  4. Clinical significant hypoglycemia

    Time frame: During the procedure

    Time in clinical significant hypoglycemia (< 3 mmol/L, <54 mg/dL) of the interstitial glucose

  5. MIG

    Time frame: During the procedure

    Mean interstitial glucose (mmol/L, mg/dL)

  6. %CV

    Time frame: During the procedure

    Percentage of the variation coefficient (%, >36% is considered high levels)

  7. Adherence to CGM

    Time frame: During the procedure

    Time of use of continuous glucose monitoring (% possible time of use)

  8. Weight

    Time frame: During the procedure

    Total corporal weight (Kg)

  9. Insulin dose

    Time frame: During the procedure

    Daily insulin dose requirements (UI/Kg/d)

  10. DKA

    Time frame: During the procedure

    Number of diabetic ketoacidosis (number of events)

  11. Severe hypoglycemia

    Time frame: During the procedure

    Number of severe hypoglycemia (number of events)

  12. Hospital admission

    Time frame: During the procedure

    Number of hospital admission due to insulin pump (number of events)

Sponsors and collaborators

Lead sponsor

Castilla-La Mancha Health Service

Other

Collaborators

  • Spanish Diabetes Association

Registry information

Official study title

Clinical Efficacy of Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients in Spain

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2021
Registry last updated
Feb 9, 2022

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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