NCT00468754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2003

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2007

Completed
Last Updated

March 3, 2016

Status Verified

June 1, 2010

Enrollment Period

1.8 years

First QC Date

May 2, 2007

Last Update Submit

March 1, 2016

Conditions

Diabetes Mellitus Type 1

Outcome Measures

Primary Outcomes (1)

  • Variability of blood glucose characterised by the standard deviation of the mean blood glucose

    Length of study

Secondary Outcomes (4)

  • 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

Study Arms (2)

A

EXPERIMENTAL
Device: Insulin pumps

B

EXPERIMENTAL
Device: Insulin pumps

Interventions

Insulin pumpsDEVICE
AB

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Bergamo, 24128, Italy

Location

Unknown Facility

Brescia, 25123, Italy

Location

Unknown Facility

Padua, 35128, Italy

Location

Unknown Facility

Pisa, 56124, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Andreas Buhr

    Disetronic Medical Systems AG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2007

First Posted

May 3, 2007

Study Start

July 1, 2003

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

March 3, 2016

Record last verified: 2010-06

Locations

IT(4)