Insulin Pump vs Multiple Daily Injections of Insulin and Glyco-metabolic Control in Type 1 Diabetic Patients
NCT ID: NCT03463564
Last Updated: 2018-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2016-01-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin pump
Insulin Pump with rapid acting insulin analog lispro
Insulin pump
Continuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.
Insulin injections
Four injections of insulin daily consisting in three bolus of a rapid-acting analog lispro or aspart before breakfast, lunch and dinner and one injection at bed-time of basal insulin glargine or degludec
Insulin injections
Four injections of insulin daily consisting in three bolus of a rapid-acting analog lispro or aspart before breakfast, lunch and dinner and one injection of insulin glargine or degludec at bed-time of basal insulin
Interventions
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Insulin pump
Continuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.
Insulin injections
Four injections of insulin daily consisting in three bolus of a rapid-acting analog lispro or aspart before breakfast, lunch and dinner and one injection of insulin glargine or degludec at bed-time of basal insulin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* persistent HbA1c levels ≥ 7.5% (58 mmol/mol) despite optimized education therapy,
* recurrent severe hypoglycemic episodes or high glucose variability
* willingness to wear the insulin pump
Exclusion Criteria
* pregnancy or planning to become pregnant in the next 2 years,
* lack of ability to use the study devices
* history of severe chronic diseases
* recent or concomitant use of corticosteroids
* drug or alcohol abuse
* psychiatric complaints that interfere with the correct use of the devices
18 Years
30 Years
ALL
No
Sponsors
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University of Campania Luigi Vanvitelli
OTHER
Responsible Party
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Katherine Esposito
Full Professor of Endocrinology and Metabolism, Head of Diabetes Unit
Principal Investigators
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Katherine Esposito
Role: PRINCIPAL_INVESTIGATOR
University of Campania Luigi Vanvitelli
Locations
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Unit of Diabetes
Naples, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24012014-33
Identifier Type: -
Identifier Source: org_study_id
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