Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Icadom | INDUSTRY |
| AGIR Ã Dom | OTHER |
| CHU Grenoble Alpes | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The objective of this study is to collect the evolution of blood glucose levels in type 2 diabetes (T2D) patients under different conditions of their daily life: physical activity, meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant T2D using a closed loop.
T2D is a condition that combines insulin resistance and relative insulin deficiency. The T2D naturally progresses towards an increasingly pronounced insulin deficiency that leads to the need for pancreatic replacement, by administering insulin.
Type 1 diabetes (T1D) requires a complete and immediate substitution of pancreatic insulin secretion. Currently, patients need to be involved in managing their disease by deciding how much insulin to administer based on the results of glucose monitoring. Artificial intelligence, thanks to a self-learning algorithm, enables the automation and customization of insulin administration. These devices, known as closed loops, bring real benefit to the patients included in the studies, by improving glycemic balance, by decreasing the number of hypo- and hyperglycemia but also by decreasing the mental load associated with the disease, improving their quality of life.
These very significant benefits in the T1D treatment open the possibility of obtaining similar benefits in the T2D treated by the basal-bolus type insulin regimen. This study aims to develop a specific algorithm of T2D to meet its particular characteristics.
The objective of this study is to collect the evolution of blood glucose levels in T2D patients under different conditions of their daily life: physical activity, meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant T2D using a closed loop.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| At home clinical data collection | Experimental | Clinical data will be collected during 7 days: physical activity, sleep duration, chronotype, food and medication intake, glucose level and insulin administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actimetry | Device | Actimetry will be performed at home to measure physical activity, sleep duration and patient chronotype for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose level modification | Continuous subcutaneous glucose level (measured by continuous glucose sensor (CGM)) for 7 days, compared to the daily activities collected and the insulin doses delivered by the insulin pump. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity | Measured by actimetry | 7 days |
| Physical activity | Measured by physical actimetry journal | 7 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anne-Laure BOREL, MD, PhD | CHU Grenoble Alpes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AGIRADOM | Meylan | 38140 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Actimetry is performed in all patients included.
Not provided
Not provided
Not provided
Not provided
| Questionnaires | Other | Patients will complete food and medication intake questionnaires for 7 days. |
|
| Glucose level and insulin administration | Other | Continuous subcutaneous glucose level (measured by continuous glucose monitor (CGM)) and the insulin doses delivered by the insulin pump will be collected for 7 days . |
|
| Sleep duration | Measured by actimetry | 7 days |
| Sleep duration | Measured by sleep journal | 7 days |
| Patient's chronotype | Measured by actimetry | 7 days |
| Patient's chronotype | Measured by sleep journal | 7 days |
| Schedule and type of food intake | Questionnaire on schedule and type of food intake (without score on a scale) | 7 days |
| Medication intake | Questionnaire on medication intake (without score on a scale) | 7 days |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |