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Type 1 DiabetesPhase 3DID3NCT01192711

Insulin Administration Plus a Telemedicine System (Diabetes Interactive Diary - DID) vs Insulin Plus Common Practice

A Phase 3 study testing Diabetes Interactive Diary (DID) in people with Type 1 Diabetes, run by Consorzio Mario Negri Sud at 13 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The Diabetes Interactive Diary (DID) is both a CHO (carbohydrates )/insulin bolus calculator, an information technology and a telemedicine system based on the communication between health care professional and patient by SMS messages. 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?
Diabetes Interactive Diary (DID)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
13 sitesItaly
Study dates
May 2009to Oct 2011
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

  • Individuals with type 1 diabetes as defined by the criteria of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (29)
  • Males and females
  • Age equal or more than 18 years
  • Patients not habitually using CHO (carbohydrates) counting
  • Self monitoring blood glucose (SMBG) at least 3 times a day
  • Four basal-bolus daily injections of short-acting and long-acting insulin analogues
Show all 9Show fewer
  • HbA1c equal or more than 7.5%
  • Female patients have to be postmenopausal, hysterectomised or surgically sterilized or using reliable and adequate contraceptive methods (oral contraception or IUD);
  • A full study-specific informed consent must be obtained in writing for all subjects

Who cannot join

  • Multiple daily injections of NPH insulin or soluble rapid insulin or Continuous Subcutaneous Insulin Infusion (CSII) therapy
  • Mental conditions, depression, or high anxiety rendering the subject unable to understand the nature, scope, and possible consequences of the study
  • Eating disorders
  • Pregnancy / lactation.
  • Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases or infective diseases making implementation of the protocol or interpretation of the study results difficult
  • Any disease or condition including abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator may interfere with the completion of the study
  • Subjects unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures.

Trial locations and contacts

13 sites in 1 country.

Antonio Nicolucci, MD contact

+39 0872 570 ext. 260

nicolucci@negrisud.it

Maria C Rossi contact

+39 0872 570 ext. 266

mrossi@negrisud.it

13 sites in 1 country

Italy13 sites, 13 recruiting

  • Ospedale G.B. Morgagni - L. Pierantoni

    Forlì, 47100

    Silvia Acquati, MD, +39 0543 731199, s.acquati@ausl.fo.it

    Silvia Acquati, MD

    Not yet recruiting

  • P.O. di Grosseto - Stabilimento Misericordia

    Grosseto, 58100

    Mauro Rossi, MD, +39 0564 485272, m.rossi@usl9.toscana.it

    Mauro Rossi, MD

    Recruiting

  • Az. Osp. S. Anna - Presidio Ospedaliero Cantù - Mariano Comense

    Mariano Comense, 22066

    Luigi Sciangula, MD, +39 031 755357, luigi.sciangula@hsacomo.org

    Luigi Sciangula, MD

    Recruiting

  • Istituto Scientifico San Raffaele

    Milan, 20132

    Andrea Laurenzi, MD, +39 02 2643 ext. 2894, laurenzi.andrea@hsr.it

    Gabriella Galimberti, MD

    Recruiting

  • Ospedale Niguarda Cà Granda

    Milan, 20162

    Andrea M Bonomo, MD, +39 02 64443912, matteo.bonomo@ospedaleniguarda.it

    Andrea M Bonomo, MD

    Recruiting

  • II Università di Napoli Centro Regionale di Diabetologia Pediatrica "G. Stoppoloni"

    Naples, 80138

    Dario Iafusco, MD, +39 081 5665434, dario.iafusco@unina2.it

    Francesco Prisco, MD

    Recruiting

  • Università degli Studi di Padova Dipartimento di Medicina Clinica e Sperimentale

    Padua, 35128

    Alberto Maran, MD, +39 049 8212097, alberto.maran@unipd.it

    Alberto Maran, MD

    Recruiting

  • Ospedale Cisanello

    Pisa, 56124

    Stefano Del Prato, MD, +39 050 995100, delprato@immr.med.unipi.it

    Stefano Del Prato, MD

    Recruiting

  • U.O. di Diabetologia, Dip. di Malattie Digestive & Metaboliche

    Ravenna, 48100

    Paolo Di Bartolo, MD, +39 0544 286326, p.dibartolo@ausl.ra.it

    Paolo Di Bartolo, MD

    Recruiting

  • Ospedale Infermi

    Rimini, 47900

    Cinzia Trojani, MD, +39 0541 705370, ctrojani@auslrn.net

    Cinzia Trojani, MD

    Not yet recruiting

  • Ospedale Sandro Pertini

    Rome, 00157

    Concetta Suraci, MD, +39 06 41433513, tsuraci@tiscali.it

    Concetta Suraci, MD

    Recruiting

  • Ospedale Magati

    Scandiano, 42019

    Valerio Miselli, MD, +39 0522 850247, miselliv@ausl.re.it

    Valerio Miselli, MD

    Not yet recruiting

  • Azienda Ospedaliera-Universitaria S. Giovanni Battista

    Turin, 10126

    Giorgio Grassi, MD, +39 011 6335605, giorgio.grassi@gmail.com

    Giorgio Grassi, MD

    Recruiting

Other trials in Italy

About this study

Official title: An Open Label, Multicentre, Randomized Study of Insulin Glargine + Prandial Insulin Glulisine Associated With a Telemedicine System for Carbohydrates Counting vs. Insulin Glargine + Prandial Insulin Glulisine Associated With Common Practice

The Diabetes Interactive Diary (DID) is both a CHO (carbohydrates )/insulin bolus calculator, an information technology and a telemedicine system based on the communication between health care professional and patient by SMS messages.

Aim of the study is to compare an insulin regimen of insulin glargine + prandial insulin glulisine associated with a telemedicine system to teach CHO counting (DID) with the same insulin regimen administered according to usual practice.

Conditions
Type 1 Diabetes
Being tested
Diabetes Interactive Diary (DID)
Keywords
diabetes, telemedicine, self monitoring blood glucose
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diabetes Interactive Diary (DID)Device

    DID is both a CHO/insulin bolus calculator, an information technology and a telemedicine system based on the communication between health care professional (physician or dietitian) and patient by SMS messages.

Study groups in NCT01192711
Study groupRoleWhat they receive
insulin + DIDExperimentalThree prandial (before or at the end of meal administration, based on doctor counselling and patient decision) injections per day of insulin glulisine associated with basal insulin glargine; the DID will be used to estimate the CHO content of the food intended to eat. Insulin doses in this group will be adjusted based on DID calculations and pre-meal BG values.
Receives: Device: Diabetes Interactive Diary (DID)
insulin + usual careNo interventionThree prandial (before or at the end of meal administration, based on doctor counselling and patient decision) injections of insulin glulisine associated with basal insulin glargine. Insulin doses in group B will be adjusted based on SMBG values reviewed during the doctor office visit.

What is being measured

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

  1. Blood levels of glycosylated hemoglobin

    Measured: from baseline every three months until the end of the study

Secondary outcomes (8)

  1. blood glucose (BG) levels

    Changes in BG levels from baseline to end of study (fasting BG, pre-/post-prandial BG, nocturnal BG, mean daily BG)

    Measured: from baseline every three months until the end of the study

  2. Glucose variability

    Glucose variability (MAGE, coefficient of variation of mean fasting BG and post-prandial BG)

    Measured: from baseline every three months until the end of the study

  3. Change in body weight and BMI

    Measured: from baseline every three months until the end of the study

  4. Total daily insulin dose, total basal insulin dose, total prandial insulin dose

    Measured: from baseline every three months until the end of the study

  5. Quality of life

    the quality of life will be measured by Diabetes Specific Quality of Life Scale (DSQOLS) and Diabetes Treatment Satisfaction Questionnaire (DTSQ)

    Measured: at baseline and at the end of the study

  6. Frequency of patients with hypoglycemic episodes and frequency of hypoglycemic episodes overall

    Measured: every three months until the end of the study

  7. Frequency of patients with severe and/or symptomatic hypoglycemia and frequency of severe and/or symptomatic hypoglycemic episodes overall

    Measured: every three months until the end of the study

  8. Frequency and times of hypoglycemic events with regard to occurrence during the day (24 hours) and total treatment duration (24 weeks)

    Measured: every three months until the end of the study

Timeline

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

  1. First posted1 Sep 2010 (estimated)
  2. Study startMay 2009
  3. Primary completionOct 2011 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01192711
Sponsor's protocol ID
MTD003
Acronym
DID3
Status last verified
Sep 2010
First submitted
31 Aug 2010
Last updated
2 Sep 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Diabetes Interactive Diary (DID) in people with Type 1 Diabetes, run by Consorzio Mario Negri Sud at 13 sites in Italy.

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 9 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: status not confirmed, as of the sponsor's last update on 2 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Antonio Nicolucci, MD (+39 0872 570 ext. 260, nicolucci@negrisud.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood levels of glycosylated hemoglobin (time frame: from baseline every three months until the end of the study). 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 NCT01192711.

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 2 Sep 2010.

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