Flexible, Intensive Insulin Therapy in Patients With Type... | NCT00595569

Studies
Flexible, Intensive Insulin Therapy in Patients With Type 1 Diabetes

NCT00595569

Sponsor

University of Lausanne Hospitals

Status

Completed

Last Update Posted

Jan 16, 2008Estimated

Enrollment

45Actual

Phase

Not provided

Conditions

Diabetes Mellitus, Type 1

Interventions

Flexible insulin therapy (FIT)

Countries

Switzerland

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
120/04

Status Module

Record Verification Date

Dec 2007

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

Apr 2002

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Dec 28, 2007

First Submission Date that Met QC Criteria

Jan 15, 2008

First Posted Date

Jan 16, 2008Estimated

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

Jan 15, 2008

Last Update Posted Date

Jan 16, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of Lausanne HospitalsOTHER

Collaborators

Name	Class
Diabetes Association Basel	OTHER
University Hospital, Basel, Switzerland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To prospectively evaluate the long term metabolic and psychological effects of flexible intensive insulin therapy (FIT) courses in an unselected population of type 1 diabetic patients at the University of Basel Hospital. We hypothesize that both metabolic control and psychological parameters will improve.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Type 1 diabetes			Behavioral: Flexible insulin therapy (FIT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flexible insulin therapy (FIT)	Behavioral	Flexible insulin therapy (FIT) courses consisting in 7 weekly ambulatory sessions lasting 90 minutes each	Type 1 diabetes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Metabolic control (HbA1c, severe hypoglycemic events), psychological effects, diabetes knowledge		Over 18 months

Secondary Outcomes

Measure	Description	Time Frame
Changes in insulin doses, changes in weight		Over 18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients participating in 5 consecutive FIT courses that began between April 2002 to April 2004

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients with type 1 diabetes followed at the Division of Endocrinology and Diabetology, University of Basel are strongly encouraged to attend the course 6 to 12 months after having been diagnosed. The population that participates in those FIT courses includes patients from the University of Basel Hospital, but also patients that are referred from out of hospital physicians/diabetologists.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jardena J Puder, MD	University of Lausanne, University of Basel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Basel Hospital		Basel			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D003920	Diabetes Mellitus
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided