Clinical Efficacy of Insulin Pumps in Type 1 Diabetes Mellitus Patients in Spain
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| ClinicalTrials.gov Identifier: NCT04761094 |
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Recruitment Status :
Completed
First Posted : February 18, 2021
Last Update Posted : February 9, 2022
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| Condition or disease | Intervention/treatment |
|---|---|
| Type 1 Diabetes | Device: Insulin pump |
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.
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 2977 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Target Follow-Up Duration: | 9 Months |
| Official Title: | Clinical Efficacy of Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients in Spain |
| Actual Study Start Date : | September 1, 2021 |
| Actual Primary Completion Date : | December 31, 2021 |
| Actual Study Completion Date : | December 31, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Insulin pump
All patient treated with insulin pump.
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Device: Insulin pump
Treatment with continuous subcutaneous insulin infusion |
- HbA1C [ Time Frame: During the procedure ]Glycated haemoglobin A1C
- TIR [ Time Frame: During the procedure ]Time in range (TIR, 3.9-10 mmol/L, 70-180 mg/dL) of the interstitial glucose
- TAR [ Time Frame: During the procedure ]Time above range (TAR, >10 mmol/L, >180 mg/dL) of the interstitial glucose
- TUR [ Time Frame: During the procedure ]Time under range (TUR, <3.9 mmol/L, <70 mg/dL) of the interstitial glucose
- Clinical significant hypoglycemia [ Time Frame: During the procedure ]Time in clinical significant hypoglycemia (< 3 mmol/L, <54 mg/dL) of the interstitial glucose
- MIG [ Time Frame: During the procedure ]Mean interstitial glucose (mmol/L, mg/dL)
- %CV [ Time Frame: During the procedure ]Percentage of the variation coefficient (%, >36% is considered high levels)
- Adherence to CGM [ Time Frame: During the procedure ]Time of use of continuous glucose monitoring (% possible time of use)
- Weight [ Time Frame: During the procedure ]Total corporal weight (Kg)
- Insulin dose [ Time Frame: During the procedure ]Daily insulin dose requirements (UI/Kg/d)
- DKA [ Time Frame: During the procedure ]Number of diabetic ketoacidosis (number of events)
- Severe hypoglycemia [ Time Frame: During the procedure ]Number of severe hypoglycemia (number of events)
- Hospital admission [ Time Frame: During the procedure ]Number of hospital admission due to insulin pump (number of events)
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Type 1 diabetes patients treated with insulin pump.
- Medical treatment received in Spain.
Exclusion Criteria:
- Any other kinds of diabetes.
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): NCT04761094
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| Responsible Party: | Jesús Moreno Fernández, Endocrinologist, Castilla-La Mancha Health Service |
| ClinicalTrials.gov Identifier: | NCT04761094 |
| Other Study ID Numbers: |
C-386 |
| First Posted: | February 18, 2021 Key Record Dates |
| Last Update Posted: | February 9, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | IPD will be available after studying each request. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Type 1 diabetes Treatment Insulin pump Continuous subcutaneous insulin infusion |
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Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs |