Type 1 DiabetesBLOOMNCT05418699
Real-life Data From Diabetic Patients on Closed-loop Pumps
An observational study of Type 1 Diabetes, run by Groupe Hospitalier de la Rochelle Ré Aunis at 5 sites in France.
Trial summary
To evaluate, in real life, the effect of closed-loop devices on the improvement of glycemic control in diabetic patients managed in the endocrinology departments of secondary care hospitals. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- closed-loop insulin pump
- Type of treatment
- Medical device
- How many people
- 410 participants
- Where
- 5 sitesFrance
- Study dates
- 26 Sep 2022to 31 Mar 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Type I diabetic patients with a closed-loop insulin pump between April 2020 and August 2023
Who may be able to join
- type I diabetic
- with a closed-loop insulin pump
Who cannot join
- under legal protection order
- patient or legal guardian objecting to the use of the data in the research
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CH Béthune-Beuvry
Béthune
CH Boulogne-sur-Mer
Boulogne-sur-Mer
CH Dax
Dax
CHI Mont de Marsan et du Pays des Sources
Mont-de-Marsan
CH Périgueux
Périgueux
About this study
To evaluate, in real life, the effect of closed-loop devices on the improvement of glycemic control in diabetic patients managed in the endocrinology departments of secondary care hospitals.
Read the detailed description
In recent years, closed-loop insulin delivery have been developed to deliver real-time glucose-responsive insulin to people with type 1 diabetes mellitus (T1DM). Their use has been validated in clinical trials, but international investigative centers participating in clinical trials are not always representative of secondary care centers, and the patients they manage are also different. The eligibility criteria for participants in clinical trials are more stringent and restrictive than those of the usual patient population of diabetes/endocrinology centers. The socio-demographic characteristics of patients in clinical trials, in particular the ratio of males to females, age or ethnicity, do not necessarily reflect those observed in patients actually using the device.
- Conditions
- Type 1 Diabetes
- Being tested
- closed-loop insulin pump
- 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.
closed-loop insulin pumpDevice
Follow up of patients with real-time closed-loop insulin delivery systems
| Study group | Role | What they receive |
|---|---|---|
| Type I diabetic patient | Not described Receives: Device: closed-loop insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Level
Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
Measured: At 3 months
Secondary outcomes (19)
HbA1c Level
Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
Measured: At 6 months
HbA1c Level
Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
Measured: At 12 months
Time in Range
Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days
Measured: At 3 months
Time in Range
Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days
Measured: At 6 months
Time in Range
Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days
Measured: At 12 months
Time Below Range
Percentage of time with glucose values below 70 mg/dL in the last 14 days
Measured: At 3 months
Time Below Range
Percentage of time with glucose values below 70 mg/dL in the last 14 days
Measured: At 6 months
Time Below Range
Percentage of time with glucose values below 70 mg/dL in the last 14 days
Measured: At 12 months
Time Above Range
Percentage of time with glucose values above 180 mg/dL in the last 14 days
Measured: At 3 months
Time Above Range
Percentage of time with glucose values above 180 mg/dL in the last 14 days
Measured: At 6 months
Time Above Range
Percentage of time with glucose values above 180 mg/dL in the last 14 days
Measured: At 12 months
Coefficient of Variation
Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
Measured: At 3 months
Coefficient of Variation
Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
Measured: At 6 months
Coefficient of Variation
Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
Measured: At 12 months
HbA1c Level
Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
Measured: at 18 months
Time in Range
Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days
Measured: at 18 months
Time Below Range
Percentage of time with glucose values below 70 mg/dL in the last 14 days
Measured: at 18 months
Time Above Range
Percentage of time with glucose values above 180 mg/dL in the last 14 days
Measured: at 18 months
Coefficient of Variation
Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
Measured: at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start26 Sep 2022
- Primary completion10 Oct 2023
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Retrospective
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier GOUET, MD, Study director, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418699
- Sponsor's protocol ID
- 2022/P02/540
- Acronym
- BLOOM
- Status last verified
- Feb 2026
- First submitted
- 10 Jun 2022
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The database will be made available on a general-purpose open repository. Medical Subject Headings (MESH) terms will be used to describe clinical data. International standard unit will be used. Keyword are type I diabetes, Insulin Infusion Systems, Patient Outcome Assessment
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Data From Diabetic Patients on Closed-loop Pumps
- ClinicalTrials.gov ID
- NCT05418699
- Acronym / sponsor ID
- BLOOM / 2022/P02/540
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate, in real life, the effect of closed-loop devices on the improvement of glycemic control in diabetic patients managed in the endocrinology departments of secondary care hospitals.
Detailed description
In recent years, closed-loop insulin delivery have been developed to deliver real-time glucose-responsive insulin to people with type 1 diabetes mellitus (T1DM). Their use has been validated in clinical trials, but international investigative centers participating in clinical trials are not always representative of secondary care centers, and the patients they manage are also different. The eligibility criteria for participants in clinical trials are more stringent and restrictive than those of the usual patient population of diabetes/endocrinology centers. The socio-demographic characteristics of patients in clinical trials, in particular the ratio of males to females, age or ethnicity, do not necessarily reflect those observed in patients actually using the device.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type I diabetic patient | – | Device: closed-loop insulin pump |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type I diabetic patients with a closed-loop insulin pump between April 2020 and August 2023
Key inclusion criteria (2 listed)
- type I diabetic
- with a closed-loop insulin pump
Key exclusion criteria (2 listed)
- under legal protection order
- patient or legal guardian objecting to the use of the data in the research
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 |
|---|---|---|
| closed-loop insulin pumpFollow up of patients with real-time closed-loop insulin delivery systems | Device | Type I diabetic patient |
Primary outcome
HbA1c Level
Time frame: At 3 months
Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
19 secondary outcomes
HbA1c Level
Time frame: At 6 months
HbA1c Level
Time frame: At 12 months
Time in Range
Time frame: At 3 months
Time in Range
Time frame: At 6 months
Time in Range
Time frame: At 12 months
Time Below Range
Time frame: At 3 months
Time Below Range
Time frame: At 6 months
Time Below Range
Time frame: At 12 months
Time Above Range
Time frame: At 3 months
Time Above Range
Time frame: At 6 months
Time Above Range
Time frame: At 12 months
Coefficient of Variation
Time frame: At 3 months
Coefficient of Variation
Time frame: At 6 months
Coefficient of Variation
Time frame: At 12 months
HbA1c Level
Time frame: at 18 months
Time in Range
Time frame: at 18 months
Time Below Range
Time frame: at 18 months
Time Above Range
Time frame: at 18 months
Coefficient of Variation
Time frame: at 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The database will be made available on a general-purpose open repository. Medical Subject Headings (MESH) terms will be used to describe clinical data. International standard unit will be used. Keyword are type I diabetes, Insulin Infusion Systems, Patient Outcome Assessment
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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.
Didier GOUET, MD study director
Groupe Hospitalier de la Rochelle Ré Aunis
5 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 Groupe Hospitalier de la Rochelle Ré Aunis at 5 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 2 inclusion and 2 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 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
HbA1c Level (time frame: At 3 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 12 Mar 2026.