Type 1 Diabetes Mellitus Maturity OnsetSmartguardNCT03047486
Smartguard Use in Real Life : a Longitudinal Study in Patients With Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus Maturity Onset, run by University Hospital, Caen at 1 site in France.
Trial summary
The reference treatment of the type 1 diabetes is intensified insulin therapy by insulin pump. The CGM (continuous glucose monitoring) is a technology available for a decade, which allows the continuous measure of interstitial glucose rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus Maturity Onset
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2017to 1 Jan 2018
- Phase
- Observational
- 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
Study population: This prospective trial involved adult patients with Type 1 Diabetes for at least 1 year, and a treatement by insulin pump (CSII) for at least 6 months, to study and describe the efficacy and safety of the predictive low glucose suspend (PLGS) system in real life, in difficult diabetes (severe hypoglycemia, unawared hypoglycemia, brittle diabetes).
Who may be able to join
- Type 1 diabetes ≥ 1 year
- CSII ≥ 6 months
- Previous education to flexible insulin therapy
- Patient willing to use sensors and smartguard option for 1 year
- A1c ≥ 7.5% and/or severe hypoglycemia ≥ 2 episodes during the last 6 month and/or recurrent hypoglycemia and/or hypoglycemia unawareness and/or brittle diabetes
Who cannot join
- No access to a computer and/or to the web making it impossible to follow patients through telemedicine
Trial locations and contacts
1 site in 1 country.
France1 site
Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
Caen, 14000
About this study
The reference treatment of the type 1 diabetes is intensified insulin therapy by insulin pump. The CGM (continuous glucose monitoring) is a technology available for a decade, which allows the continuous measure of interstitial glucose rate. The results are available in real time to the user, who can so use them to optimize the adjustment of its treatment by insulin pump. Since a few years, several research programs aim for finalizing an automated system using the data of real time interstitial glucose to adjust automatically, via an algorithm, the release of insulin by the pump. This type of closed-loop system is for the moment only experimental, not still widely available in routine. On the other hand, rudimentary regulation systems partially automated already exist and can be used in common clinical practice. One of these systems, Smartguard ®, allows this type of regulation to decrease the hypoglycemic risk of the patients treated by insulin pump. It is indeed a hypo minimizer which interrupts the basal output when the algorithm embarked on the pump determines thanks to the CGM data what a hypoglycemia risks to occur in the 30 minutes. The efficiency of this system to reduce hypoglycemias was proved by several studies in pediatric and adult populations of subjects with DT1 (Diabetes Care on 2015; 38:1197-1204. J Diabetes Sci Technol. 2016 May 20. Pii: 1932296816645119). However, to date, there are no published data concerning the method of use of this system (sensor et pump initial configuration; patient education), nor the evolution of the sensor and pump parameters during the use.
The aim of this observationnelle study is to collect the data of efficiency, safety and use of the system Smartguard ® in common clinical practice in an adult population of subjects DT1.
- Conditions
- Type 1 Diabetes Mellitus Maturity Onset
- Keywords
- insulin pump, continuous glucose monitoring sensor, predictive low glucose suspend
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose TIR (time in range) from CGM recording
TIR will be calculated from the CGM recording, thanks to the medtronic carelink software
Measured: change between baseline and after 12 month
Glucose Time below range (hypoglycemia < 70 mg/dl) from CGM recording
Time below range will be calculated from the CGM recording, thanks to the medtronic carelink software
Measured: change between baseline and after 12 month
Secondary outcomes (1)
HbA1c
Measured: month 0, 3, 6, 9, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes Mellitus Maturity OnsetStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael JOUBERT, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047486
- Sponsor's protocol ID
- 16-106
- Acronym
- Smartguard
- Status last verified
- Feb 2017
- First submitted
- 7 Feb 2017
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Joubert M, Briant AR, Kessler L, Fall-Mostaine F, Dubois S, Guerci B, Schoumacker-Ley L, Reznik Y, Parienti JJ. Sensor-Augmented Insulin Pump with Predictive Low-Glucose Suspend (PLGS): Determining Optimal Settings of Pump and Sensor in a Multicenter Cohort of Patients with Type 1 Diabetes. Diabetes Ther. 2022 Sep;13(9):1645-1657. doi: 10.1007/s13300-022-01302-3. Epub 2022 Aug 1.
PubMed 35913656
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartguard Use in Real Life : a Longitudinal Study in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03047486
- Acronym / sponsor ID
- Smartguard / 16-106
- Conditions
- Type 1 Diabetes Mellitus Maturity Onset
- Keywords
- insulin pump, continuous glucose monitoring sensor, predictive low glucose suspend
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 9 Feb 2017 (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 reference treatment of the type 1 diabetes is intensified insulin therapy by insulin pump. The CGM (continuous glucose monitoring) is a technology available for a decade, which allows the continuous measure of interstitial glucose rate. The results are available in real time to the user, who can so use them to optimize the adjustment of its treatment by insulin pump. Since a few years, several research programs aim for finalizing an automated system using the data of real time interstitial glucose to adjust automatically, via an algorithm, the release of insulin by the pump. This type of closed-loop system is for the moment only experimental, not still widely available in routine. On the other hand, rudimentary regulation systems partially automated already exist and can be used in common clinical practice. One of these systems, Smartguard ®, allows this type of regulation to decrease the hypoglycemic risk of the patients treated by insulin pump. It is indeed a hypo minimizer which interrupts the basal output when the algorithm embarked on the pump determines thanks to the CGM data what a hypoglycemia risks to occur in the 30 minutes. The efficiency of this system to reduce hypoglycemias was proved by several studies in pediatric and adult populations of subjects with DT1 (Diabetes Care on 2015; 38:1197-1204. J Diabetes Sci Technol. 2016 May 20. Pii: 1932296816645119). However, to date, there are no published data concerning the method of use of this system (sensor et pump initial configuration; patient education), nor the evolution of the sensor and pump parameters during the use.
The aim of this observationnelle study is to collect the data of efficiency, safety and use of the system Smartguard ® in common clinical practice in an adult population of subjects DT1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective trial involved adult patients with Type 1 Diabetes for at least 1 year, and a treatement by insulin pump (CSII) for at least 6 months, to study and describe the efficacy and safety of the predictive low glucose suspend (PLGS) system in real life, in difficult diabetes (severe hypoglycemia, unawared hypoglycemia, brittle diabetes).
Key inclusion criteria (5 listed)
- Type 1 diabetes ≥ 1 year
- CSII ≥ 6 months
- Previous education to flexible insulin therapy
- Patient willing to use sensors and smartguard option for 1 year
- A1c ≥ 7.5% and/or severe hypoglycemia ≥ 2 episodes during the last 6 month and/or recurrent hypoglycemia and/or hypoglycemia unawareness and/or brittle diabetes
Key exclusion criteria (1 listed)
- No access to a computer and/or to the web making it impossible to follow patients through telemedicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glucose TIR (time in range) from CGM recording
Time frame: change between baseline and after 12 month
TIR will be calculated from the CGM recording, thanks to the medtronic carelink software
Glucose Time below range (hypoglycemia < 70 mg/dl) from CGM recording
Time frame: change between baseline and after 12 month
Time below range will be calculated from the CGM recording, thanks to the medtronic carelink software
1 secondary outcome
HbA1c
Time frame: month 0, 3, 6, 9, 12
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 2 Apr 2026.
- Results publication: PubMed 35913656Joubert M, Briant AR, Kessler L, Fall-Mostaine F, Dubois S, Guerci B, Schoumacker-Ley L, Reznik Y, Parienti JJ. Sensor-Augmented Insulin Pump with Predictive Low-Glucose Suspend (PLGS): Determining Optimal Settings of Pump and Sensor in a Multicenter Cohort of Patients with Type 1 Diabetes. Diabetes Ther. 2022 Sep;13(9):1645-1657. doi: 10.1007/s13300-022-01302-3. Epub 2022 Aug 1.
- Individual participant dataSharing planned: No
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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.
Michael JOUBERT, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus Maturity Onset, run by University Hospital, Caen 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 5 inclusion and 1 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 2 Apr 2026. 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.
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?
Glucose TIR (time in range) from CGM recording (time frame: change between baseline and after 12 month). The study lists 2 primary outcomes in all. 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 NCT03047486, 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 2 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.