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NCT Number: NCT00937703

Multicentric Evaluation of Two Telematics Systems in Type 2 Diabetic Patients in Failure of Oral Treatment and Having to Start Treatment by Basal Insulin

TELEDIAB-2 is a national, multicenter, controlled, randomised trial. The primary objective of the study is to show that during the initiation of a basal insulin treatment , a computerized decision-making system of adaptation of the insulin, coupled to a distance follow-up (thanks to PDAphone or an interactive vocal server (IVS)), is able to improve metabolic control at the end of 4 mouths as compared with conventional care.

Main judgment criteria: comparison of HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group at 4 months.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Aix en Provence, Aix-en-Provence, France

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About this study

Secondary objectives :

  • - To compare the 2 methods of telemonitoring employed.
  • - To evaluate the speed of the glycemic attack of the objective to the rising, according to the method of follow-up employed.
  • - To evaluate the satisfaction of the patients and the doctors with respect to systems of telemonitoring, and improvement of the quality of life (DQOL).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes since more than 3 years and claiming a strict balance glycemic;
  • Patients treated since at least 3 months, by metformin and secreting insulinic (KNOWN or glinide);
  • Patients uncontrolled with HbA1c ≥ 7.5% and < 10% at the inclusion.
  • BMI < 40 ;
  • Patients requiring a insulin treatment
  • Patients agree to start a slow insulin treatment
  • Patients already practising the glycemic self-monitoring or agree to learn it and practise it;
  • Patients able to include/understand operation and to use the PDA-phone and/or the SVI;
  • Patient not taking part in another biomedical research study
  • Patients agree to carry out at least 2 finger sticks per day;
  • More than 18 years, there is no higher age limit.

Exclusion criteria

  • Patients introducing any evolutionary pathology associated and not stabilized, exhibitor with an uncontrolled diabetes during the year to come;
  • Patients in a situation which justifies of a clinical follow-up diabetologic more frequent than that (quarterly) envisaged by the study
  • Patients requiring a transitory passage to insulin;
  • Patients needing a hospitalization for the adaptation of insulin doses;
  • Patients presenting a cardiologic event
  • Patients presenting a hemoglobinopathy interfering with the proportioning of HbA1c;
  • Patients suffering from drug-addiction, alcoholism or psychological troubles
  • Type 1 or secondary diabetes
  • Patients who don't need strict metabolic objectives;
  • Pregnant or parturient patients
  • person with no freedom.

Treatment and study plan

PLACEBO

Device

paper support for glycaemia face to face visit at T4mounths

IVS

Device

patients transmit their glycaemia to the IVS, which advises them the insulin amount recommended by their physician in this situation.

Face to face visit at T4mounths plus telephone visits each 2 weeks.

PDAphone

Device

Patients will receive PDA phone system. They will hace face to face visit at T4mounths and telephone visits each 2 weeks

Primary outcomes

  1. Comparison HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group.

    Time frame: To T4 months

Secondary outcomes

  1. Comparison of absolute HbA1c difference

    Time frame: T0-T4 months

  2. Comparison of evolution of HbA1c

    Time frame: T0 and T4 months

  3. Comparison of percentage of patients reaching HbA1c < 7.0% in 4 months

    Time frame: T0 and T4 months

  4. Comparison of percentage of patients within the objective glycemic (the last 3 days Jeun Glycemia average with between 0.73 and 1.08 g/l) at the end of the study, and the average time allowing to achieve this goal

    Time frame: T0 and T4 months

  5. Comparison of the average jeun glycemia the 14 days previous the visit in 4 months

    Time frame: T4 months

  6. Comparison of the frequency of benign hypoglycemias, symptomatic or not, night and severe throughout study

    Time frame: study period

  7. Comparison of the evolution of the weight

    Time frame: T0 and T4 months

  8. Comparison of evolution of the quality of life at the beginning and at the end of the study (the scale of quality of life DHP as well as the items of dimension Satisfaction of the DQOL)

    Time frame: T0 and T4 months

  9. Comparison of the time spent by physicians with patients during visit (either face to face visits or phone call visit);

    Time frame: study period

  10. Comparison of the satisfaction of the patients and physicians with the system and willingness to carry on the use of the system in routine care

    Time frame: 4 months

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

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

Multicentric Evaluation of Two Telematics Systems (PDA Phone and IVS)in Type 2 Diabetics Patients in Failure of Oral Treatment and Having to Start a Treatment by Basal Insulin, Compared to a Conventional Care. National, Multicentric, Comparative Randomized Study

Acronym: TELEDIAB-2

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jul 13, 2009
Registry last updated
Dec 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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