A Study Comparing Continuous Subcutaneous Insulin Infusio... | NCT00468754

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

NCT00468754

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Mar 3, 2016Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus Type 1

Interventions

Insulin pumps

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
RD000000275

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

May 2005Actual

Completion Date

May 2005Actual

First Submitted Date

May 2, 2007

First Submission Date that Met QC Criteria

May 2, 2007

First Posted Date

May 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2016

Last Update Posted Date

Mar 3, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Label	Type	Description	Intervention Names
A	Experimental		Device: Insulin pumps
B	Experimental		Device: Insulin pumps

Name	Type	Description	Arm Group Labels	Other Names
Insulin pumps	Device		A B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
HbA1c		Length of study
Mean BG during the last month of the respective treatment period		Length of study
Frequency of severe hypoglycemia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Buhr	Disetronic Medical Systems AG	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Bergamo		24128	Italy

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided