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Type 1 DiabetesPhase 3TELEDIAB-1NCT00629304

Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients

A Phase 3 study testing VISITS + PDA-FIT system and PDA-FIT System + telephone follow-up in people with Type 1 Diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

TELEDIAB-1 is a national, multicenter, controlled, randomised trial. The Primary objective of the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1 diabetic patients, despite intensive insulin therapy… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
VISITS + PDA-FIT system and PDA-FIT System + telephone follow-up
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
18 sitesFrance
Study dates
Sep 2007to Aug 2009
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 ≥ 12 months or more (including C-peptide negative secondary diabetes)
  • age > 18 y.o.
  • intensive insulin basal-bolus therapy for ≥ 6 months. At inclusion, patients should be treated, either with a combination of a basal, long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump
  • chronically uncontrolled diabetes with HbA1c ≥ 8 % during the past 12 months and at inclusion

Who cannot join

  • patient with unstable associated evolutive pathology
  • patient who need a more frequent diabetic follow up (than in the protocol)
  • patient with a education teaching within the 3 months before inclusion
  • patient with a hemoglobinopathy
  • patient with toxicomania, alcoholism or psychological troubles
  • type 2 diabetes patients
Show all 9Show fewer
  • patient who don't need strict metabolic objectives
  • pregnant or parturient women
  • person with no freedom (prisoner)

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • Centre Hospitalier de Belfort Montbéliard

    Belfort, Belfort, 90016

  • CHU Jean Minjoz

    Besançon, Besancon, 25030

  • CH SUD Francilien

    Corbeil-Essonnes, Corbeil Essonnes, 91100

  • University Hospital Grenoble

    Grenoble, Grenoble, 38043

  • CHRU Lille

    Lille, Lille, 59037

  • Hopital Edouard Herriot

    Lyon, Lyon, 69003

  • CHU Marseille Hôpitaux Sud

    Marseille, Marseille, 13274

  • Chu Montpellier

    Montpellier, Montpellier, 34295

  • CHU Hôpital Jeanne d'Arc

    Nancy, Nancy, 54201

  • CHU Nantes

    Nantes, Nantes, 44093

  • Hopital Hotel Dieu

    Paris, Paris, 75004

  • Hopital COCHIN

    Paris, Paris, 75014

  • HOPITAL Saint Louis

    Paris, Paris, 75475

  • Hopital Haut Leveque

    Pessac, Pessac, 33604

  • CHU Rennes

    Rennes, Rennes, 35056

  • Hopital Bellevue

    Saint-Etienne, Saint Etienne, 42055

  • Centre Hospitalier Strasbourg

    Strasbourg, Strasbourg, 67000

  • CHU Toulouse

    Toulouse, Toulouse, 31403

Other trials in France

About this study

Official title: Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients With Chronic Failure of Intensive Insulin Therapy and Conventional Care. The TELEDIAB-1 STUDY

TELEDIAB-1 is a national, multicenter, controlled, randomised trial. The Primary objective of the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1 diabetic patients, despite intensive insulin therapy (multiple daily injections with basal-bolus insulin or insulin pump), as compared with conventional care.

Main judgment criteria: comparison of HbA1c means between the 3 groups at 6 months

Read the detailed description

Secondary Objectives :

  1. To assess the improvement of blood glucose control and quality of life in patients using the PDA-FIT system
  2. To assess the improvement in diabetes care provided by the use of the PDA-FIT system
  3. Satisfaction of patients and physicians towards the PDA-FIT system
Conditions
Type 1 Diabetes
Being tested
placebo, VISITS + PDA-FIT system, PDA-FIT System + telephone follow-up
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.

  • placeboDevice

    Also called paper support for glycemia, face to face visits at 3 and 6 months, without PDA-FIT system

    Patients will have face to face visits at 3 and 6 months and no PDA-FIT system. Patients will record glycemia on paper support.

  • VISITS + PDA-FIT systemDevice

    Also called face to face visits at 3 and 6 months, PDA-FIT system

    patients will have face to face visits at 3 and 6 months + PDA-FIT system

  • PDA-FIT System + telephone follow-upDevice

    Also called face to face visit at 6 months, telephone visits each 2 weeks, PDA-FIT system

    patients will received PDA-FIT system + a telephone follow up (12 phone calls) and a face to face visit at 6 months

Study groups in NCT00629304
Study groupRoleWhat they receive
1Placebo comparatorstandard visit at 3 and 6 months
Receives: Device: placebo
2Active comparatorPDA-FIT system + standard visit at 3 and 6 months
Receives: Device: VISITS + PDA-FIT system
3Active comparatorPDA-FIT system + 12 telephone visits + standard visit at 6 months
Receives: Device: PDA-FIT System + telephone follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of HbA1c mean between the 3 groups

    Measured: at 6 months

Secondary outcomes (12)

  1. Absolute HbA1c differences (M0-M6)

    Measured: inclusion and M6

  2. HbA1c changes at M0, M3 and M6

    Measured: inclusion, M3 and M6

  3. Percentage of patients reaching HbA1c <7.5% at 6 months

    Measured: 6 months

  4. Mean of blood glucose values as provided by glucose meters during the 14 days prior to inclusion and prior to the 6 months-visit

    Measured: 14 days prior to inclusion and prior to M6

  5. Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period

    Measured: study period

  6. Frequency of symptomatic benign hypoglycaemic episodes during the week prior to inclusion and prior to the 6 months-visit

    Measured: week before inclusion and prior to M6

  7. 8-point blood glucose profiles at inclusion and 6 months

    Measured: inclusion and M6

  8. Quality of life at inclusion and 6 months, using the DHP scale and the Satisfaction item of the DQOL questionnaire

    Measured: inclusion and M6

  9. Improvement in diabetes care, as assessed by the change in blood glucose testing frequency, reflected by the glucose meter memory

    Measured: study period

  10. Time spent by physicians with patients during visits (either face to face visits or phone call visits) and time spent by patients during transport, waiting time and lost working time

    Measured: study period

  11. Satisfaction of patients and physicians with the system and willingness to carry on the use of the system in routine care

    Measured: 6 months

  12. Effective number of patients carrying on the use of the system in routine care, at their own expense and in agreement with their physician

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionMar 2009
  4. Study completionAug 2009

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00629304
Sponsor's protocol ID
DCIC 07 08
Acronym
TELEDIAB-1
Status last verified
Aug 2009
First submitted
26 Feb 2008
Last updated
9 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • Charpentier G, Benhamou PY, Dardari D, Clergeot A, Franc S, Schaepelynck-Belicar P, Catargi B, Melki V, Chaillous L, Farret A, Bosson JL, Penfornis A; TeleDiab Study Group. The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). Diabetes Care. 2011 Mar;34(3):533-9. doi: 10.2337/dc10-1259. Epub 2011 Jan 25.

    PubMed 21266648

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VISITS + PDA-FIT system and PDA-FIT System + telephone follow-up in people with Type 1 Diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 18 sites 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 4 inclusion and 9 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 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites 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. Some participants in this study may receive a placebo. 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 mean between the 3 groups (time frame: at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00629304, which also lists 1 linked publication.

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 9 Feb 2012.

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