A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00468754

Enrollment

Registered

2007-05-03

Start date

2003-07-31

Completion date

2005-05-31

Last updated

2016-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 1

Brief summary

This trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro and glargine, a long-acting insulin analogue. Patients will be switched to the alternative treatment after 4 months. Glucose variability in the last month of each treatment will be analyzed.

Interventions

DEVICEInsulin pumps

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Inclusion criteria

* Type 1 diabetic patients, 18-60 years of age * Diabetic for \>2 years * Treated with CSII for \>=6 months * HbA1c \<8.5%

Exclusion criteria

* Treatment with daily insulin injections * Inability to handle pump therapy * Untreated retinopathy

Design outcomes

Primary

Measure	Time frame
Variability of blood glucose characterised by the standard deviation of the mean blood glucose	Length of study

Secondary

Measure	Time frame
HbA1c	Length of study
Mean BG during the last month of the respective treatment period	Length of study
Frequency of severe hypoglycemia	Length of study
Daily insulin requirement	Length of study

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026