Type 1 DiabetesPhase 2IFOPINCT01512680
Evaluation of Functional Insulin Therapy in Type 1 Diabetic Patients
A Phase 2 study testing Education to Functional Insulin Therapy in people with Type 1 Diabetes, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. The hypothesis is that FIT should lead to better glycemic control (HbA1c), less hypoglycemia and better quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Education to Functional Insulin Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Nov 2015
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70
- Type 1 diabetes for more than 1 year
- Treatment by basal/bolus insulin therapy and insulin pump for more than 6 months
- HbA1c between 7.5 and 12%
- Volunteer to be educated to Functional Insulin Therapy
- Patient must be willing to undergo all study procedures
- Patient must be affiliated or beneficiary of a social medical insurance
- Patient has signed informed consent form prior to study entry
Who cannot join
- Type 2 diabetes
- Difficulties with mathematics calculation (simple algebra)
- Patient is pregnant, or breast feeding during the period of the study
- Manifest psychological disorders
- Patient with eating behaviour desorder
- Alcohol or drug addiction, as identified by investigator during screening visit
- Persons deprived of freedom, adults protected by law or vulnerable persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Functional Insulin Therapy on Blood Glucose Control in Type 1 Diabetic Patients Treated by Insulin Pumps
Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. The hypothesis is that FIT should lead to better glycemic control (HbA1c), less hypoglycemia and better quality of life. 60 patient will be enrolled and followed during one year.
Read the detailed description
Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. In this study we plan to enroll 60 patients who will be educated toFIT and followed during one year. Patient will follow normal path of eductation which is composed of a 3 days inpatient admission, a medical visit one month after the education, and a 4hours reminder session six months after the education. We will compare HbA1c, hypoglycemia, weight, before the education, and after. Patient will also wear a continuous glucose sensor during one week before, at month 6 and month 12 to allow comparison of glucose variablity.
- Conditions
- Type 1 Diabetes
- Being tested
- Education to Functional Insulin Therapy
- Keywords
- Functional Insulin Thearpy, Carbs counting, Type 1 diabetes mellitus, Insulin pump, Treatment by external insulin pump
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education to Functional Insulin TherapyBehavioural
- Intake of Continuous Glucose Monitor for 5 to 7 days
- "Functional Insulinotherapy" training during 3 days, blood sampling, autoevaluation and QOL questionnary.
- 1 month after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes
- 3 months after the training: Blood sampling, vital signs and data on diabetes
- 6 months after the training: 2 sessions of training, blood sampling, autoevaluation and QOL questionnary, vital signs and data on diabetes, Intake of Continuous Glucose Monitor for 5 to 7 days
- 9 months after the training: Blood sampling, vital signs and data on diabetes
- 1 to 3 weeks before last visit: Intake of Continuous Glucose Monitor for 5 to 7 days
- 12 months after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes, autoevaluation and QOL questionnary
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes patient | Experimental | Type 1 diabetes patient are included in this study to have an education to Functional Insulin Therapy (intervention) Receives: Behavioral: Education to Functional Insulin Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between HbA1c at Month 12 and Month 0 > 0.5%
Measured: at baseline et at Month 12
Secondary outcomes (7)
Difference between HbA1c at Month 3 and Month 0 > 0.3%
Measured: at baseline et at Month 3
Difference between HbA1c at Month 6 and Month 0 > 0.5%
Measured: at baseline and at Month 6
Difference between HbA1c at Month 9 and Month 0 > 0.5%
Measured: at baseline and at Month 9
Reduction of 50% of hypoglycemia < 60mg/dl
Measured: at Month 12
Reduction of 30% of hypoglycemia between 60 and 80mg/dl
Measured: at Month 12
Reduction of number of patients who have severe hypoglycemia
Measured: at MONTH 12
Better score at surveys of quality of life (SF-6D, DQOL) and auto-management
Measured: at baseline, at Month 6 and at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric ER RENARD, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512680
- Sponsor's protocol ID
- 8749
- Other IDs
- ID-RCB : 2011-A00645-36
- Acronym
- IFOPI
- Status last verified
- Nov 2016
- First submitted
- 16 Dec 2011
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional Insulin Therapy on Blood Glucose Control in Type 1 Diabetic Patients Treated by Insulin Pumps
- ClinicalTrials.gov ID
- NCT01512680
- Acronym / sponsor ID
- IFOPI / 8749
- Conditions
- Type 1 Diabetes
- Keywords
- Functional Insulin Thearpy, Carbs counting, Type 1 diabetes mellitus, Insulin pump, Treatment by external insulin pump
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 19 Jan 2012 (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.
Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. The hypothesis is that FIT should lead to better glycemic control (HbA1c), less hypoglycemia and better quality of life. 60 patient will be enrolled and followed during one year.
Detailed description
Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. In this study we plan to enroll 60 patients who will be educated toFIT and followed during one year. Patient will follow normal path of eductation which is composed of a 3 days inpatient admission, a medical visit one month after the education, and a 4hours reminder session six months after the education. We will compare HbA1c, hypoglycemia, weight, before the education, and after. Patient will also wear a continuous glucose sensor during one week before, at month 6 and month 12 to allow comparison of glucose variablity.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes patient | Experimental | Behavioral: Education to Functional Insulin TherapyType 1 diabetes patient are included in this study to have an education to Functional Insulin Therapy (intervention) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 70
- Type 1 diabetes for more than 1 year
- Treatment by basal/bolus insulin therapy and insulin pump for more than 6 months
- HbA1c between 7.5 and 12%
- Volunteer to be educated to Functional Insulin Therapy
Key exclusion criteria (7 listed)
- Type 2 diabetes
- Difficulties with mathematics calculation (simple algebra)
- Patient is pregnant, or breast feeding during the period of the study
- Manifest psychological disorders
- Patient with eating behaviour desorder
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 |
|---|---|---|
| Education to Functional Insulin Therapy* Intake of Continuous Glucose Monitor for 5 to 7 days * "Functional Insulinotherapy" training during 3 days, blood sampling, autoevaluation and QOL questionnary. * 1 month after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes * 3 months after the training: Blood sampling, vital signs and data on diabetes * 6 months after the training: 2 sessions of training, blood sampling, autoevaluation and QOL questionnary, vital signs and data on diabetes, Intake of Continuous Glucose Monitor for 5 to 7 days * 9 months after the training: Blood sampling, vital signs and data on diabetes * 1 to 3 weeks before last visit: Intake of Continuous Glucose Monitor for 5 to 7 days * 12 months after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes, autoevaluation and QOL questionnary | Behavioural | Type 1 diabetes patient |
Primary outcome
Difference between HbA1c at Month 12 and Month 0 > 0.5%
Time frame: at baseline et at Month 12
7 secondary outcomes
Difference between HbA1c at Month 3 and Month 0 > 0.3%
Time frame: at baseline et at Month 3
Difference between HbA1c at Month 6 and Month 0 > 0.5%
Time frame: at baseline and at Month 6
Difference between HbA1c at Month 9 and Month 0 > 0.5%
Time frame: at baseline and at Month 9
Reduction of 50% of hypoglycemia < 60mg/dl
Time frame: at Month 12
Reduction of 30% of hypoglycemia between 60 and 80mg/dl
Time frame: at Month 12
Reduction of number of patients who have severe hypoglycemia
Time frame: at MONTH 12
Better score at surveys of quality of life (SF-6D, DQOL) and auto-management
Time frame: at baseline, at Month 6 and at Month 12
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 29 Nov 2016.
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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.
Eric ER RENARD, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Education to Functional Insulin Therapy in people with Type 1 Diabetes, run by University Hospital, Montpellier at 1 site in France.
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 8 inclusion and 7 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 29 Nov 2016. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference between HbA1c at Month 12 and Month 0 > 0.5% (time frame: at baseline et at Month 12). 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 29 Nov 2016.