Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type I diabetic patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| closed-loop insulin pump | Device | Follow up of patients with real-time closed-loop insulin delivery systems |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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% | At 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | 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% |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Type I diabetic patients with a closed-loop insulin pump between April 2020 and August 2023
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Didier GOUET, MD | Groupe Hospitalier de la Rochelle Ré Aunis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Béthune-Beuvry | Béthune | France | ||||
| CH Boulogne-sur-Mer |
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
Data will be made available with publication. A Digital Object Identifier will be used.
The only available version will be the locked database. With the exception of dates, all data will be made available. Dates will only be collected to verify the quality of the clinical trial execution. They do not add to the clinical question, and may be a means of indirectly identifying patients.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Type I Diabetic Patient | Patients with a confirmed diagnosis of type 1 diabetes mellitus (T1DM) who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Type I Diabetic Patient | Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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% | Posted | Mean | Standard Deviation | percentage of HBA1c | At 3 months |
|
|
18 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Type I Diabetic Patient | Patients with a confirmed diagnosis of T1DM who initiated use of the MiniMed 780G™ system for glycemic regulation under the care of general hospital-based endocrinology or diabetes services |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe hypoglycemia | Endocrine disorders | MedDRA 28.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical device change | Endocrine disorders | MedDRA 28.1 | Systematic Assessment | End the use of the hybrid closed-loop system and revert to an open system. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Didier Gouet | Groupe Hospitalier de la Rochelle Ré Aunis | +335 46 45 51 31 | didier.gouet@ght-atlantique17.fr |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2022 | Feb 20, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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 | 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 | At 12 months |
| Time Below Range | Percentage of time with glucose values below 70 mg/dL in the last 14 days | At 3 months |
| Time Below Range | Percentage of time with glucose values below 70 mg/dL in the last 14 days | At 6 months |
| Time Below Range | Percentage of time with glucose values below 70 mg/dL in the last 14 days | At 12 months |
| Time Above Range | Percentage of time with glucose values above 180 mg/dL in the last 14 days | At 3 months |
| Time Above Range | Percentage of time with glucose values above 180 mg/dL in the last 14 days | At 6 months |
| Time Above Range | Percentage of time with glucose values above 180 mg/dL in the last 14 days | At 12 months |
| Coefficient of Variation | Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage) | At 3 months |
| Coefficient of Variation | Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage) | At 6 months |
| Coefficient of Variation | Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage) | 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% | 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 | at 18 months |
| Time Below Range | Percentage of time with glucose values below 70 mg/dL in the last 14 days | at 18 months |
| Time Above Range | Percentage of time with glucose values above 180 mg/dL in the last 14 days | at 18 months |
| Coefficient of Variation | Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage) | at 18 months |
| Boulogne-sur-Mer |
| France |
| CH Dax | Dax | France |
| CHI Mont de Marsan et du Pays des Sources | Mont-de-Marsan | France |
| CH Périgueux | Périgueux | France |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg^m2 |
|
| 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% | Mean | Standard Deviation | percentage of HBA1c |
|
| Time in range | Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days | Mean | Standard Deviation | percentage of time spent in range |
|
| Time below range | Percentage of time with glucose values below 70 mg/dL in the last 14 days | Mean | Standard Deviation | percentage of time spent below range |
|
| Time above range | Percentage of time with glucose values above 180 mg/dL in the last 14 days | Mean | Standard Deviation | percentage of time spent above range |
|
| Coefficient of variation | Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage) | Mean | Standard Deviation | percentage of coefficient of variation |
|
|
| Secondary | 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% | Posted | Mean | Standard Deviation | percentage of HBA1c | At 6 months |
|
|
|
| Secondary | 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% | Posted | Mean | Standard Deviation | percentage of HBA1c | At 12 months |
|
|
|
| Secondary | Time in Range | Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days | Posted | Mean | Standard Deviation | percentage of time spent in range | At 3 months |
|
|
|
| Secondary | Time in Range | Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days | Posted | Mean | Standard Deviation | percentage of time spent in range | At 6 months |
|
|
|
| Secondary | Time in Range | Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days | Posted | Mean | Standard Deviation | percentage of time spent in range | At 12 months |
|
|
|
| Secondary | Time Below Range | Percentage of time with glucose values below 70 mg/dL in the last 14 days | Posted | Mean | Standard Deviation | percentage of time spent below range | At 3 months |
|
|
|
| Secondary | Time Below Range | Percentage of time with glucose values below 70 mg/dL in the last 14 days | Posted | Mean | Standard Deviation | percentage of time spent below range | At 6 months |
|
|
|
| Secondary | Time Below Range | Percentage of time with glucose values below 70 mg/dL in the last 14 days | Posted | Mean | Standard Deviation | percentage of time spent below range | At 12 months |
|
|
|
| Secondary | Time Above Range | Percentage of time with glucose values above 180 mg/dL in the last 14 days | Posted | Mean | Standard Deviation | percentage of time spent above range | At 3 months |
|
|
|
| Secondary | Time Above Range | Percentage of time with glucose values above 180 mg/dL in the last 14 days | Posted | Mean | Standard Deviation | percentage of time spent above range | At 6 months |
|
|
|
| Secondary | Time Above Range | Percentage of time with glucose values above 180 mg/dL in the last 14 days | Posted | Mean | Standard Deviation | percentage of time spent above range | At 12 months |
|
|
|
| Secondary | Coefficient of Variation | Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage) | Posted | Mean | Standard Deviation | percentage of coefficient of variation | At 3 months |
|
|
|
| Secondary | Coefficient of Variation | Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage) | Posted | Mean | Standard Deviation | percentage of coefficient of variation | At 6 months |
|
|
|
| Secondary | Coefficient of Variation | Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage) | Posted | Mean | Standard Deviation | percentage of coefficient of variation | At 12 months |
|
|
|
| Secondary | 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% | Posted | Mean | Standard Deviation | percentage of HBA1c | at 18 months |
|
|
|
| Secondary | Time in Range | Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days | Posted | Mean | Standard Deviation | percentage of HBA1c | at 18 months |
|
|
|
| Secondary | Time Below Range | Percentage of time with glucose values below 70 mg/dL in the last 14 days | Posted | Mean | Standard Error | percentage of time spent below range | at 18 months |
|
|
|
| Secondary | Time Above Range | Percentage of time with glucose values above 180 mg/dL in the last 14 days | Posted | Mean | Standard Deviation | percentage of time spent above range | at 18 months |
|
|
|
| Secondary | Coefficient of Variation | Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage) | Posted | Mean | Standard Deviation | percentage of coefficient of variation | at 18 months |
|
|
|
| 0 |
| 410 |
| 26 |
| 410 |
| 184 |
| 410 |
| Ketoacidaemia | Endocrine disorders | MedDRA 28.1 | Systematic Assessment |
|
| Hospitalisation | Endocrine disorders | MedDRA 28.1 | Systematic Assessment |
|
|
| Device end of service | Endocrine disorders | MedDRA 28.1 | Systematic Assessment |
|
| Device defective | Endocrine disorders | MedDRA 28.1 | Systematic Assessment | Transmitter replacement |
|
| Device defective | Endocrine disorders | MedDRA 28.1 | Systematic Assessment | Sensor malfunctions |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |