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

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

Detailed Description
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Insulin pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes patients treated with insulin pump. Medical treatment received in Spain. Exclusion Criteria: - Any other kinds of diabetes.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Insulin pump<br>All patient treated with insulin pump. | Device: Insulin pump<br>* Treatment with continuous subcutaneous insulin infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C | Glycated haemoglobin A1C | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIR | Time in range (TIR, 3.9-10 mmol/L, 70-180 mg/dL) of the interstitial glucose | During the procedure | 
| TAR | Time above range (TAR, >10 mmol/L, >180 mg/dL) of the interstitial glucose | During the procedure | 
| TUR | Time under range (TUR, <3.9 mmol/L, <70 mg/dL) of the interstitial glucose | During the procedure | 
| Clinical significant hypoglycemia | Time in clinical significant hypoglycemia (< 3 mmol/L, <54 mg/dL) of the interstitial glucose | During the procedure | 
| MIG | Mean interstitial glucose (mmol/L, mg/dL) | During the procedure | 
| %CV | Percentage of the variation coefficient (%, >36% is considered high levels) | During the procedure | 
| Adherence to CGM | Time of use of continuous glucose monitoring (% possible time of use) | During the procedure | 
| Weight | Total corporal weight (Kg) | During the procedure | 
| Insulin dose | Daily insulin dose requirements (UI/Kg/d) | During the procedure | 
| DKA | Number of diabetic ketoacidosis (number of events) | During the procedure | 
| Severe hypoglycemia | Number of severe hypoglycemia (number of events) | During the procedure | 
| Hospital admission | Number of hospital admission due to insulin pump (number of events) | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, Treatment, Insulin pump, Continuous subcutaneous insulin infusion