Type 1 DiabetesSEECLOOPNCT06363916
Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System
An observational study of Type 1 Diabetes, run by Medtrum France at 17 sites in France.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults with type 1 diabetes (7-75 years old) in a home setting and to test the function of meal announcement in an extend study. Read more about this study
- Who is it for?
- Ages 7 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulin Management System in Manual mode of operation and Insulin Management System in Automatic mode of operation
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 17 sitesFrance
- Study dates
- 15 Apr 2024to Dec 2025
- 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 7 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Type 1 diabetes subjects with insulin therapy delivered by pump (aged over 7 years), current or previous insulin pump user or patient treated with multiple insulin injections.
Who may be able to join
- Patients living with Type 1 diabetes:
- adults aged 18 to 75 years old (included)
- children/adolescents aged 7 or older
- Total daily dose of insulin ≥ 10 units per day \& weighing >22 Kg
- Patient and their parent(s)/guardian(s) trained and able to count carb
- Current or previous insulin pump user or patient treated with multiple insulin injections
Show all 11Show fewer
- Patient glycaemic target is not achieved or suboptimal according to international consensus: HbA1c level equal and greater than 7% and less than 12% at the time of enrolment, or TIR < 70%, or TBR >4%
- Any type of rapid insulin with a total daily insulin in the range of 10-60 IU (unauthorized use of insulin supplements by pen injector): Humalog™, Lyumjev (insulin lispro injection), Novorapid (insulin aspart) or FIASP® (" faster insulin aspart ")
- Subject and their parent(s)/guardian(s) able to receive and understand study information, give written informed consent, and easily participate to the trial
- Subject and their parent(s)/guardian(s) affiliated to the French social security system
- Subject and their parent(s)/guardian(s) have the cognitive ability and can successfully operate all study devices and can adhere to the protocol
Who cannot join
- Patient unable to tolerate tape adhesive, catheter or had any unresolved adverse skin condition and intolerance to steel
- Patient not willing to perform finger stick blood glucose measurements required by the system and/or routine diabetes management
- Patient with behaviour/lifestyle not compatible with optimal management of insulin therapy or deemed to be at significant risk of severe events (e.g. severe hypoglycaemia, diabetic ketoacidosis)
- Unstable diabetic retinopathy
- Pregnant women or planning to become pregnant during the study or breast-feeding
- Patient abusing alcohol
Show all 10Show fewer
- Patient using DPP-4 inhibitor, GLP-1 agonists, metformin, or SGLT2 inhibitors during the last 3 months prior screening
- Patient already participating in another interventional study
- Patient currently using a hybrid closed loop system or patient who has stopped usage of Hybrid Closed loop system for less than 3 months
- Patient under the protection of justice or under guardianship or curatorship, or hospitalised under duress or admitted to a health or social care establishment for purposes other than those of this investigation.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites, 17 recruiting
- Not yet recruiting
CHU Angers
Angers
Regis COUTANT
Regis COUTANT
- Not yet recruiting
CHU Besançon
Besançon
Sophie BOROT
Sophie BOROT
- Not yet recruiting
CHU Bordeaux
Bordeaux
Bogdan CATARGI
Bogdan CATARGI
- Not yet recruiting
CHU Caen
Caen
Michael JOUBERT
Michael JOUBERT
- Recruiting
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes
Freddy PENFORNIS
Freddy PENFORNIS
- Recruiting
Centre Hospitalier de Gonesse
Gonesse
Jennifer ALLAIN
Jennifer ALLAIN
- Not yet recruiting
Centre Hospitalier Saint-Louis
La Rochelle
Didier GOUET
Didier GOUET
- Recruiting
Hôpital Hôtel-Dieu
Le Creusot
Sylvaine CLAVEL
Sylvaine CLAVEL
- Not yet recruiting
Hospices Civils de Lyon
Lyon
Charles THIVOLET
Charles THIVOLET
- Not yet recruiting
Hôpital Européen
Marseille
Denis RACCAH
Denis RACCAH
- Not yet recruiting
Hôpital La Timone
Marseille
Rachel REYNAUD
Rachel REYNAUD
- Not yet recruiting
CHU Montpellier
Montpellier
Fabienne DALLA VALE
Fabienne DALLA VALE
- Not yet recruiting
CHU Nantes
Nantes
Lucy CHAILLOUS
Lucy CHAILLOUS
- Not yet recruiting
Hôpital Lariboisière
Paris
Jean-Pierre RIVELINE
Jean-Pierre RIVELINE
- Not yet recruiting
Hôpital Necker
Paris
Jacques BELTRAND
Jacques BELTRAND
- Not yet recruiting
Hôpital Robert Debré
Paris
Elise BISMUTH
Elise BISMUTH
- Not yet recruiting
Hôpital Rangueil
Toulouse
Vincent MELKI
Vincent MELKI
About this study
Official title: Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System in Children, Adolescents and Adults With Type 1 Diabetes
The purpose of this study is to evaluate the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults with type 1 diabetes (7-75 years old) in a home setting and to test the function of meal announcement in an extend study.
The main question it aims to answer is :
Read more
- Is the Hybrid Closed Loop system superior at increasing the time spent in the target glucose range of 70-180 mg/dL when compared to the Open (manual) Loop system ?
Participants will be :
- Trained into the use of the Insulin pump MEDTRUM A8 TouchCare® Insulin Management system
- Randomized to the Open Loop or Closed Loop group
- Respond to self administered questionnaires : the Hypoglycaemia Fear Survey, the Diabetes Quality of Life Questionnaire, and the Diabetes treatment Satisfaction Questionnaire status
Researchers will compare the time spent in the target glucose range of 70-180 mg/mL during the last 12 weeks of the study between the patients randomised to the Open Loop group and those randomised to the Closed Loop group.
- Conditions
- Type 1 Diabetes
- Being tested
- Insulin Management System in Manual mode of operation, Insulin Management System in Automatic mode of operation
- 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.
Insulin Management System in Manual mode of operationDevice
MEDTRUM A8 TouchCare® Insulin Management system which includes:
- Patch pump: Pump base integrated with Hybrid Close Loop (HCL) algorithm not activated
- Reservoir Patches
- Continuous glucose monitoring (CGM): Glucose Sensor + Transmitter
- Personal Diabetes Manager (PDM) and/or EasyPatch® App
- EasyFollow® App, EasyView® website System is in conformity with EC marking n° HD 601 357 110001- TUV Rheinland dated February 19th of year 2019 and completed by system DoC 881160 dated June 30th of year 2020.
EasyPatch mobile application is in conformity with EC marking n°709972 - BSI - dated March 6th 2020
Insulin Management System in Automatic mode of operationDevice
MEDTRUM A8 TouchCare® Insulin Management system which includes:
- Patch pump: Pump base integrated with Hybrid Close Loop (HCL) algorithm activated
- Reservoir Patches
- Continuous glucose monitoring (CGM): Glucose Sensor + Transmitter
- Personal Diabetes Manager (PDM) and/or EasyPatch® App
- EasyFollow® App, EasyView® website System is in conformity with EC marking n° HD 601 357 110001- TUV Rheinland dated February 19th of year 2019 and completed by system DoC 881160 dated June 30th of year 2020.
EasyPatch mobile application is in conformity with EC marking n°709972 - BSI - dated March 6th 2020
| Study group | Role | What they receive |
|---|---|---|
| Open Loop | Patients using the Insulin Management System device in a manual mode of operation. Patient must use the interface directly to deliver insulin. The algorithm will not be activated. Receives: Device: Insulin Management System in Manual mode of operation | |
| Closed Loop | Patients using the Insulin Management System device in the Closed Loop mode of operation. The algorithm will be activated. The algorithm is capable of delivery of insulin based on sensor derived glucose levels, glucose level trends and insulin pump delivery history.
Patients in this group can continue to an exploratory phase for the Automatic Meal Management function. Receives: Device: Insulin Management System in Automatic mode of operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups
Comparison between the 2 groups of the proportion of time spent in the target glucose range of 70-180 mg/dL based on sensor measured glucose concentrations during last 12 weeks of the study
Measured: V5 (6 months)
Secondary outcomes (15)
Evolution of TIR
Evolution of the time spent in the target glucose range of 70-180 mg/dL based on sensor measured glucose concentrations between visits V1-V2, V2-V4, V2-V5, in each group
Measured: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Evolution of coefficient of glycemic variation
Evolution of coefficient of glycemic variation (CV) between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group
Measured: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Superiority in Glycated Haemoglobin (HbA1c) improvement
Comparison between the 2 groups of the HbA1c change between visits V2 and V5
Measured: V2 (Randomisation), V5 (6 months)
Evolution of Time spent Above Range (TAR)
Evolution of the time spent >180 mg/dL and >250 mg/dL, between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group
Measured: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Evolution of Time spent Below Range (TBR)
Evolution of the time spent <54 mg/dL and <70 mg/dL, between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group
Measured: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Body Mass Index change
Body Mass Index change (Mean value, Standard Deviation) between visits V1-V2, and V2-V5, in each group
Measured: V1 (Inclusion), V2 (Randomisation), V5 (6 months)
Glucose sensor measurement change
Evolution of glucose sensor measurements (Mean value, Standard Deviation) between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group
Measured: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Percentage of patients with TIR > 70%
Percentage of patients having spent >70% of their time in the target glucose range (70-180 mg/dL) between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group
Measured: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Percentage of patients with TIR > 70% and TBR < 4%, and with TIR > 70% and TBR < 1%
Percentage of patients having spent >70% of their time in the target glucose range (70-180 mg/dL) and <4% of their time below range (54 to 70 mg/dL) and percentage of patients having spent >70% of their time in the target glucose range (70-180 mg/dL) and <1% of their time below range (54 to 70 mg/dL) between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group
Measured: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Evolution of glucose management indicator (GMI)
Evolution of glucose management indicator values between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group
Measured: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Evolution of dosage of insulin
Modification of total daily dose of insulin, of basal dose of insulin and bolus dose of insulin between Visit V1-V2, between visits V1-V2, V2-V4, V2-V5, and over the last 12 weeks period of the study, in each group
Measured: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Time of device usage and time in automatic mode of insulin delivery (hybrid closed loop)
Time of sensor usage in percentage and time spent in Auto Mode during study
Measured: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Evolution of Self-administered Questionnaires scores
Evolution of Self-administered Questionnaire Hypoglycaemia Fear Survey (HFS) score between visits V1 and V5
Measured: V1 (Inclusion), V5 (6 months)
Evolution of Diabetes Treatment Satisfaction score
Evolution of Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score between visits V1 and V5
Measured: V1 (Inclusion), V5 (6 months)
Safety Events
Occurrence of Safety Events as defined by ISO 14155, including severe hypoglycaemia and ketoacidosis, local tolerance events related to devices (pump and sensor), incidents occuring with Medtrum devices
Measured: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start15 Apr 2024
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtrum France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Axonal-Biostatem
- Responsible party
- Sponsor
- Investigators
- Freddy PENFORNIS, Principal investigator, Centre Hospitalier Sud-Francilien, Corbeil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363916
- Sponsor's protocol ID
- 2023-A00335-40
- Acronym
- SEECLOOP
- Status last verified
- Jun 2024
- First submitted
- 5 Apr 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System in Children, Adolescents and Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06363916
- Acronym / sponsor ID
- SEECLOOP / 2023-A00335-40
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Medtrum FranceIndustry (pharma, biotech, devices)
- Collaborators
- Axonal-Biostatem
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Apr 2024 (actual)
- 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 evaluate the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults with type 1 diabetes (7-75 years old) in a home setting and to test the function of meal announcement in an extend study.
The main question it aims to answer is :
- Is the Hybrid Closed Loop system superior at increasing the time spent in the target glucose range of 70-180 mg/dL when compared to the Open (manual) Loop system ?
Participants will be :
- Trained into the use of the Insulin pump MEDTRUM A8 TouchCare® Insulin Management system
- Randomized to the Open Loop or Closed Loop group
- Respond to self administered questionnaires : the Hypoglycaemia Fear Survey, the Diabetes Quality of Life Questionnaire, and the Diabetes treatment Satisfaction Questionnaire status
Researchers will compare the time spent in the target glucose range of 70-180 mg/mL during the last 12 weeks of the study between the patients randomised to the Open Loop group and those randomised to the Closed Loop group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Loop | – | Device: Insulin Management System in Manual mode of operationPatients using the Insulin Management System device in a manual mode of operation. Patient must use the interface directly to deliver insulin. The algorithm will not be activated. |
| Closed Loop | – | Device: Insulin Management System in Automatic mode of operationPatients using the Insulin Management System device in the Closed Loop mode of operation. The algorithm will be activated. The algorithm is capable of delivery of insulin based on sensor derived glucose levels, glucose level trends and insulin pump delivery history. Patients in this group can continue to an exploratory phase for the Automatic Meal Management function. |
Who may qualify
- Ages
- 7 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type 1 diabetes subjects with insulin therapy delivered by pump (aged over 7 years), current or previous insulin pump user or patient treated with multiple insulin injections.
Key inclusion criteria (11 listed)
- Patients living with Type 1 diabetes:
- Total daily dose of insulin ≥ 10 units per day \& weighing >22 Kg
- Patient and their parent(s)/guardian(s) trained and able to count carb
- Current or previous insulin pump user or patient treated with multiple insulin injections
- Patient glycaemic target is not achieved or suboptimal according to international consensus: HbA1c level equal and greater than 7% and less than 12% at the time of enrolment, or TIR < 70%, or TBR >4%
Key exclusion criteria (10 listed)
- Patient unable to tolerate tape adhesive, catheter or had any unresolved adverse skin condition and intolerance to steel
- Patient not willing to perform finger stick blood glucose measurements required by the system and/or routine diabetes management
- Patient with behaviour/lifestyle not compatible with optimal management of insulin therapy or deemed to be at significant risk of severe events (e.g. severe hypoglycaemia, diabetic ketoacidosis)
- Unstable diabetic retinopathy
- Pregnant women or planning to become pregnant during the study or breast-feeding
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 |
|---|---|---|
| Insulin Management System in Manual mode of operationMEDTRUM A8 TouchCare® Insulin Management system which includes: * Patch pump: Pump base integrated with Hybrid Close Loop (HCL) algorithm not activated * Reservoir Patches * Continuous glucose monitoring (CGM): Glucose Sensor + Transmitter * Personal Diabetes Manager (PDM) and/or EasyPatch® App * EasyFollow® App, EasyView® website System is in conformity with EC marking n° HD 601 357 110001- TUV Rheinland dated February 19th of year 2019 and completed by system DoC 881160 dated June 30th of year 2020. EasyPatch mobile application is in conformity with EC marking n°709972 - BSI - dated March 6th 2020 | Device | Open Loop |
| Insulin Management System in Automatic mode of operationMEDTRUM A8 TouchCare® Insulin Management system which includes: * Patch pump: Pump base integrated with Hybrid Close Loop (HCL) algorithm activated * Reservoir Patches * Continuous glucose monitoring (CGM): Glucose Sensor + Transmitter * Personal Diabetes Manager (PDM) and/or EasyPatch® App * EasyFollow® App, EasyView® website System is in conformity with EC marking n° HD 601 357 110001- TUV Rheinland dated February 19th of year 2019 and completed by system DoC 881160 dated June 30th of year 2020. EasyPatch mobile application is in conformity with EC marking n°709972 - BSI - dated March 6th 2020 | Device | Closed Loop |
Primary outcome
Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups
Time frame: V5 (6 months)
Comparison between the 2 groups of the proportion of time spent in the target glucose range of 70-180 mg/dL based on sensor measured glucose concentrations during last 12 weeks of the study
15 secondary outcomes
Evolution of TIR
Time frame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Evolution of coefficient of glycemic variation
Time frame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Superiority in Glycated Haemoglobin (HbA1c) improvement
Time frame: V2 (Randomisation), V5 (6 months)
Evolution of Time spent Above Range (TAR)
Time frame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Evolution of Time spent Below Range (TBR)
Time frame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Body Mass Index change
Time frame: V1 (Inclusion), V2 (Randomisation), V5 (6 months)
Glucose sensor measurement change
Time frame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Percentage of patients with TIR > 70%
Time frame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Percentage of patients with TIR > 70% and TBR < 4%, and with TIR > 70% and TBR < 1%
Time frame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Evolution of glucose management indicator (GMI)
Time frame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Evolution of dosage of insulin
Time frame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Time of device usage and time in automatic mode of insulin delivery (hybrid closed loop)
Time frame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Evolution of Self-administered Questionnaires scores
Time frame: V1 (Inclusion), V5 (6 months)
Evolution of Diabetes Treatment Satisfaction score
Time frame: V1 (Inclusion), V5 (6 months)
Safety Events
Time frame: V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Freddy PENFORNIS principal investigator
Centre Hospitalier Sud-Francilien, Corbeil
17 sites 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, run by Medtrum France at 17 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 11 inclusion and 10 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 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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.
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 Mélanie MARMOUNIER (0620591224, melanie.marmounier@medtrum.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups (time frame: V5 (6 months)). 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 18 Jun 2024.