Diabetes Mellitus, Type 1NCT00595569
Flexible, Intensive Insulin Therapy in Patients With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Flexible insulin therapy (FIT)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2002to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- All patients participating in 5 consecutive FIT courses that began between April 2002 to April 2004
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flexible, Intensive Insulin Management in Patients With Type 1 Diabetes and Changes in Metabolic Control, Quality of Life, Locus of Control and Diabetes Knowledge
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Flexible insulin therapy (FIT)
- Keywords
- flexible insulin therapy, diabetes education, diabetes, insulin, Weekly ambulatory sessions
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible insulin therapy (FIT)Behavioural
Flexible insulin therapy (FIT) courses consisting in 7 weekly ambulatory sessions lasting 90 minutes each
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes | Not described Receives: Behavioral: Flexible insulin therapy (FIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic control (HbA1c, severe hypoglycemic events), psychological effects, diabetes knowledge
Measured: Over 18 months
Secondary outcomes (1)
Changes in insulin doses, changes in weight
Measured: Over 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startApr 2002
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Association Basel, University Hospital, Basel, Switzerland
- Investigators
- Jardena J Puder, MD, Principal investigator, University of Lausanne, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595569
- Sponsor's protocol ID
- 120/04
- Other IDs
- 120/04
- Status last verified
- Dec 2007
- First submitted
- 28 Dec 2007
- Last updated
- 16 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible, Intensive Insulin Management in Patients With Type 1 Diabetes and Changes in Metabolic Control, Quality of Life, Locus of Control and Diabetes Knowledge
- ClinicalTrials.gov ID
- NCT00595569
- Acronym / sponsor ID
- 120/04
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- flexible insulin therapy, diabetes education, diabetes, insulin, Weekly ambulatory sessions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- Diabetes Association Basel, University Hospital, Basel, Switzerland
- Study start
- Apr 2002
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes | – | Behavioral: Flexible insulin therapy (FIT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- All patients participating in 5 consecutive FIT courses that began between April 2002 to April 2004
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible insulin therapy (FIT)Flexible insulin therapy (FIT) courses consisting in 7 weekly ambulatory sessions lasting 90 minutes each | Behavioural | Type 1 diabetes |
Primary outcome
Metabolic control (HbA1c, severe hypoglycemic events), psychological effects, diabetes knowledge
Time frame: Over 18 months
1 secondary outcome
Changes in insulin doses, changes in weight
Time frame: Over 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jardena J Puder, MD principal investigator
University of Lausanne, University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic control (HbA1c, severe hypoglycemic events), psychological effects, diabetes knowledge (time frame: Over 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2008.