Type 1 Diabetes
Conditions
Brief 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.
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.
Interventions
DEVICEclosed-loop insulin pump
Follow up of patients with real-time closed-loop insulin delivery systems
Sponsors
Groupe Hospitalier de la Rochelle Ré Aunis
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* type I diabetic * with a closed-loop insulin pump
Exclusion criteria
* under legal protection order * patient or legal guardian objecting to the use of the data in the research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Level | 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% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Level | At 6 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% |
| Time in Range | At 3 months | Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days |
| Time Below Range | At 3 months | Percentage of time with glucose values below 70 mg/dL in the last 14 days |
| Time Above Range | At 3 months | Percentage of time with glucose values above 180 mg/dL in the last 14 days |
| Coefficient of Variation | At 3 months | Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage) |
Countries
France
Contacts
STUDY_DIRECTORDidier GOUET, MD
Groupe Hospitalier de la Rochelle Ré Aunis
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 10 Participants |
| Age, Categorical >=65 years | 56 Participants |
| Age, Categorical Between 18 and 65 years | 344 Participants |
| Age, Continuous | 46 years STANDARD_DEVIATION 16 |
| Body mass index | 27 kg^m2 STANDARD_DEVIATION 5.8 |
| Coefficient of variation | 35 percentage of coefficient of variation STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 410 Participants |
| HbA1c level | 7.5 percentage of HBA1c STANDARD_DEVIATION 0.9 |
| Region of Enrollment France | 410 participants |
| Sex: Female, Male Female | 238 Participants |
| Sex: Female, Male Male | 172 Participants |
| Time above range | 31 percentage of time spent above range STANDARD_DEVIATION 13.6 |
| Time below range | 3 percentage of time spent below range STANDARD_DEVIATION 3.5 |
| Time in range | 64 percentage of time spent in range STANDARD_DEVIATION 13.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 410 |
| other Total, other adverse events | 184 / 410 |
| serious Total, serious adverse events | 26 / 410 |
Outcome results
None listed