Type 1 Diabetes MellitusPhase 3NCT00324584
Web-Based Follow-Up Using Cellular Phone in Type 1 Diabetic Patients Under Insulin Pump Therapy : The PumpNet Study
A Phase 3 study testing Telemonitoring of glucose values using GlucoNet device in people with Type 1 Diabetes Mellitus, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
The purpose of this study is to determine if telecare using modern telecommunication devices can improve the metabolic control and the quality of life of type 1 diabetic patients. 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?
- Telemonitoring of glucose values using GlucoNet device
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2003to Sep 2004
- 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
- Age ≥ 18
- HbA1c between 7.5 and 10%
- Treated with continuous subcutaneous insulin infusion for a minimum of 3 months
Who cannot join
- Unstabilized diabetic microangiopathy
- Ongoing pregnancy or planned pregnancy
- Unwilling to perform a minimum of 4 capillary blood tests per day
- Unable to use the GlucoNet device
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital, Department of Endocrinology
Grenoble, 38043
University Hospital, Department of Endocrinology
Toulouse, 31000
About this study
Official title: Surveillance Des données De l'Autosurveillance glycémique Via Internet Et Le réseau téléphonique GSM Chez Le diabétique De Type 1 Sous Traitement Insulinique Par Pompe Externe : Etude Prospective randomisée PumpNet.
The purpose of this study is to determine if telecare using modern telecommunication devices can improve the metabolic control and the quality of life of type 1 diabetic patients.
Read the detailed description
We aim at comparing conventional follow-up of type 1 diabetic patients treated with continuous subcutaneous insulin infusion (CSII) (face-to-face visits) with an intensive coaching using the Web and the cellular phone network for data transmission and Short Message Service (SMS). This telecommunication device is called GlucoNet. The specific objectives are to measure the efficiency of GlucoNet in improving metabolic control, reducing health care costs and improving the quality of life of patients.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Telemonitoring of glucose values using GlucoNet device
- Keywords
- type 1 diabetes mellitus, telecare, telemedicine, insulin pump therapy
- 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.
Telemonitoring of glucose values using GlucoNet deviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin HbA1c
monthly mean capillary blood glucose value
blood glucose variability index (MAGE Index and LBGI index)
quality of life score (DQOL score)
frequency of hypoglycemic episodes (<70 mg/dl)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
- Study startApr 2003
- Study completionSep 2004
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.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Investigators
- Pierre Y Benhamou, MD, PhD, Principal investigator, Universty Hospital, Grenoble, FranceHelene Hanaire, MD, PhD, Study director, University Hospital, Toulouse, FranceSerge Halimi, MD, Study director, University Hospital, Grenoble, FranceJean L Bosson, MD, PhD, Study director, CIC-INSERM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324584
- Sponsor's protocol ID
- DCIC 03 01
- Status last verified
- Jul 2006
- First submitted
- 10 May 2006
- Last updated
- 7 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Des données De l'Autosurveillance glycémique Via Internet Et Le réseau téléphonique GSM Chez Le diabétique De Type 1 Sous Traitement Insulinique Par Pompe Externe : Etude Prospective randomisée PumpNet.
- ClinicalTrials.gov ID
- NCT00324584
- Acronym / sponsor ID
- DCIC 03 01
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes mellitus, telecare, telemedicine, insulin pump therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Sep 2004
- First posted
- 11 May 2006 (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.
The purpose of this study is to determine if telecare using modern telecommunication devices can improve the metabolic control and the quality of life of type 1 diabetic patients.
Detailed description
We aim at comparing conventional follow-up of type 1 diabetic patients treated with continuous subcutaneous insulin infusion (CSII) (face-to-face visits) with an intensive coaching using the Web and the cellular phone network for data transmission and Short Message Service (SMS). This telecommunication device is called GlucoNet. The specific objectives are to measure the efficiency of GlucoNet in improving metabolic control, reducing health care costs and improving the quality of life of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 diabetes mellitus
- Age ≥ 18
- HbA1c between 7.5 and 10%
- Treated with continuous subcutaneous insulin infusion for a minimum of 3 months
Key exclusion criteria (4 listed)
- Unstabilized diabetic microangiopathy
- Ongoing pregnancy or planned pregnancy
- Unwilling to perform a minimum of 4 capillary blood tests per day
- Unable to use the GlucoNet device
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 |
|---|---|---|
| Telemonitoring of glucose values using GlucoNet device | Device | – |
Primary outcome
Glycated hemoglobin HbA1c
monthly mean capillary blood glucose value
blood glucose variability index (MAGE Index and LBGI index)
quality of life score (DQOL score)
frequency of hypoglycemic episodes (<70 mg/dl)
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 7 Jul 2006.
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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, MD, PhD principal investigator
Universty Hospital, Grenoble, France
Helene Hanaire, MD, PhD study director
University Hospital, Toulouse, France
Serge Halimi, MD study director
University Hospital, Grenoble, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telemonitoring of glucose values using GlucoNet device in people with Type 1 Diabetes Mellitus, run by University Hospital, Grenoble at 2 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 4 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 7 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Glycated hemoglobin HbA1c. The study lists 5 primary outcomes in all. 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 7 Jul 2006.