Type 1 Diabetes MellitusPhase 3TELFITNCT00758082
Reinforcement of the Impact of a Functional Insulin Therapy Training Course by Telemonotoring With a PDA-phone in Type 1 Diabetic Patients. The TELFIT Study Patients
A Phase 3 study testing paper support and PDA-phone + telemonitoring in people with Type 1 Diabetes Mellitus, run by University Hospital, Grenoble at 1 site in France.
Trial summary
TELFIT is a monocenter, controlled, randomised trial. It focuses on type 1 diabetes patients that have attended a functional insulin therapy training course. The Primary objective of the TELFIT study is to evaluate whether a PDA with telemonitoring by phone reinforces the effects of the functional insulin therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- paper support and PDA-phone + telemonitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2008to Mar 2010
- Phase
- Phase 3
- 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
Who may be able to join
- Type 1 diabetes mellitus for ≥ 6 months or more
- Age > 18 year old
- The patient has attended a functional insulin therapy class or workshop
- Insulin basal-bolus therapy for at least 6 months. At inclusion, patients should be treated either with a long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump
- Ability to understand how the PDA-phone works and ability to use it
- Social Security membership or benefit from Social Security
- Patients equipped with a memory blood glucose monitor
- Informed consent, with a signed and approved form
Who cannot join
- Underage patient, major patient under guardianship or protected by the Law
- Patient with any unstable associated evolutive pathology that could cause a diabetes imbalance within the coming year
- Change in diabetes treatment within the 3 months before inclusion or planned during the study
- Patient who needs a more frequent diabetic follow-up than in the protocol (especially severe or evolving complication due to diabetes)
- Patient attending another education program within the 3 months before inclusion or planning to attend one during the study
- Patient with toxicomania, alcoholism or psychological troubles that could impact the study
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- Type-2-diabetic patient
- Patient who doesn't need strict metabolic objectives
- Pregnant or possibly pregnant woman
- Person with no freedom (prisoner)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reinforcement of the Impact of a Functional Insulin Therapy Training Course by Telemonotoring With a PDA-phone in Type 1 Diabetic Patients. The TELFIT Study
TELFIT is a monocenter, controlled, randomised trial. It focuses on type 1 diabetes patients that have attended a functional insulin therapy training course. The Primary objective of the TELFIT study is to evaluate whether a PDA with telemonitoring by phone reinforces the effects of the functional insulin therapy training course as compared with conventional care.
Main judgment criteria: comparison of HbA1c means between M0 (start) and M3(3 months)
Read the detailed description
All patients will attend a functional insulin therapy training course and be randomized into 2 groups. One group will receive a PDA-phone and one month of phone consultations with a nurse and a physician. The other group will only have the usual paper support. This study compares the evolution of HbA1c in the 2 groups over a period of 3 months. It also assesses time spent by nurses and physicians, changes in quality of life, hypoglycaemia frequency and weight changes.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- paper support, PDA-phone + telemonitoring
- Keywords
- type 1 diabetes, PDA phone (Personal Digital Assistant), HbA1c
- 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.
paper supportDevice
Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support.
PDA-phone + telemonitoringDevice
Patients will received PDA-phone + a telephone follow up + standard visit at 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support Receives: Device: paper support |
| 2 | Experimental | PDA-phone + phone consultations + standard visit at 3 months Receives: Device: PDA-phone + telemonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of HbA1c means
Measured: M0 (start) and M3 (3 months)
Secondary outcomes (5)
Difference between theoretical insulin dose and actual dose, one week before the 3-month reevaluation session
Measured: M0 (start) and M3 (3 months)
DHP scale of quality of life and satisfaction dimension of the DQOL questionnaire
Measured: M0 (start) and M3 (3 months)
Time spent by physicians and nurses in the different groups
Measured: M0 (start) and M3 (3 months)
Weight changes during the 3-month period
Measured: M0 (start) and M3 (3 months)
Number of hypoglycemias (moderate and severe) during the 3-month period
Measured: M0 (start) and M3 (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- AGIR à Dom
- Investigators
- Pierre Y Benhamou, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758082
- Sponsor's protocol ID
- 2008-A00389-46
- Acronym
- TELFIT
- Status last verified
- Mar 2010
- First submitted
- 19 Sep 2008
- Last updated
- 11 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reinforcement of the Impact of a Functional Insulin Therapy Training Course by Telemonotoring With a PDA-phone in Type 1 Diabetic Patients. The TELFIT Study
- ClinicalTrials.gov ID
- NCT00758082
- Acronym / sponsor ID
- TELFIT / 2008-A00389-46
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes, PDA phone (Personal Digital Assistant), HbA1c
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- AGIR à Dom
- Study start
- Jul 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 23 Sep 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.
TELFIT is a monocenter, controlled, randomised trial. It focuses on type 1 diabetes patients that have attended a functional insulin therapy training course. The Primary objective of the TELFIT study is to evaluate whether a PDA with telemonitoring by phone reinforces the effects of the functional insulin therapy training course as compared with conventional care.
Main judgment criteria: comparison of HbA1c means between M0 (start) and M3(3 months)
Detailed description
All patients will attend a functional insulin therapy training course and be randomized into 2 groups. One group will receive a PDA-phone and one month of phone consultations with a nurse and a physician. The other group will only have the usual paper support. This study compares the evolution of HbA1c in the 2 groups over a period of 3 months. It also assesses time spent by nurses and physicians, changes in quality of life, hypoglycaemia frequency and weight changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: paper supportPatients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support |
| 2 | Experimental | Device: PDA-phone + telemonitoringPDA-phone + phone consultations + standard visit at 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 1 diabetes mellitus for ≥ 6 months or more
- Age > 18 year old
- The patient has attended a functional insulin therapy class or workshop
- Insulin basal-bolus therapy for at least 6 months. At inclusion, patients should be treated either with a long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump
- Ability to understand how the PDA-phone works and ability to use it
Key exclusion criteria (10 listed)
- Underage patient, major patient under guardianship or protected by the Law
- Patient with any unstable associated evolutive pathology that could cause a diabetes imbalance within the coming year
- Change in diabetes treatment within the 3 months before inclusion or planned during the study
- Patient who needs a more frequent diabetic follow-up than in the protocol (especially severe or evolving complication due to diabetes)
- Patient attending another education program within the 3 months before inclusion or planning to attend one during the study
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 |
|---|---|---|
| paper supportPatients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support. | Device | 1 |
| PDA-phone + telemonitoringPatients will received PDA-phone + a telephone follow up + standard visit at 3 months | Device | 2 |
Primary outcome
Comparison of HbA1c means
Time frame: M0 (start) and M3 (3 months)
5 secondary outcomes
Difference between theoretical insulin dose and actual dose, one week before the 3-month reevaluation session
Time frame: M0 (start) and M3 (3 months)
DHP scale of quality of life and satisfaction dimension of the DQOL questionnaire
Time frame: M0 (start) and M3 (3 months)
Time spent by physicians and nurses in the different groups
Time frame: M0 (start) and M3 (3 months)
Weight changes during the 3-month period
Time frame: M0 (start) and M3 (3 months)
Number of hypoglycemias (moderate and severe) during the 3-month period
Time frame: M0 (start) and M3 (3 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 11 Mar 2010.
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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.
Pierre Y Benhamou, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing paper support and PDA-phone + telemonitoring in people with Type 1 Diabetes Mellitus, run by University Hospital, Grenoble 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 10 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 11 Mar 2010. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Comparison of HbA1c means (time frame: M0 (start) and M3 (3 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 11 Mar 2010.