Type 1 Diabetes
Conditions
Keywords
Type 1 diabetes, Treatment, Insulin pump, Continuous subcutaneous insulin infusion
Brief summary
Observational cross-sectional multicenter study about clinical efficacy of insulin pumps in type 1 diabetes mellitus patients.
Detailed description
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.
Interventions
DEVICEInsulin pump
Treatment with continuous subcutaneous insulin infusion
Sponsors
Spanish Diabetes Association
Castilla-La Mancha Health Service
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes patients treated with insulin pump. * Medical treatment received in Spain.
Exclusion criteria
\- Any other kinds of diabetes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1C | During the procedure | Glycated haemoglobin A1C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TAR | During the procedure | Time above range (TAR, \>10 mmol/L, \>180 mg/dL) of the interstitial glucose |
| TUR | During the procedure | Time under range (TUR, \<3.9 mmol/L, \<70 mg/dL) of the interstitial glucose |
| Clinical significant hypoglycemia | During the procedure | Time in clinical significant hypoglycemia (\< 3 mmol/L, \<54 mg/dL) of the interstitial glucose |
| MIG | During the procedure | Mean interstitial glucose (mmol/L, mg/dL) |
| %CV | During the procedure | Percentage of the variation coefficient (%, \>36% is considered high levels) |
| TIR | During the procedure | Time in range (TIR, 3.9-10 mmol/L, 70-180 mg/dL) of the interstitial glucose |
| Weight | During the procedure | Total corporal weight (Kg) |
| Insulin dose | During the procedure | Daily insulin dose requirements (UI/Kg/d) |
| DKA | During the procedure | Number of diabetic ketoacidosis (number of events) |
| Severe hypoglycemia | During the procedure | Number of severe hypoglycemia (number of events) |
| Hospital admission | During the procedure | Number of hospital admission due to insulin pump (number of events) |
| Adherence to CGM | During the procedure | Time of use of continuous glucose monitoring (% possible time of use) |
Countries
Spain
Outcome results
None listed