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
| Name | Class |
|---|---|
| Stanford University | OTHER |
| University of Colorado, Denver | OTHER |
| Mount Sinai Hospital, New York | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study trials a prototype artificial pancreas system that consists of a Roche insulin pump, a Dexcom continuous glucose monitor (CGM), and an experiential MMPPC (multiple model probabilistic predictive control) algorithm housed on an android cell phone. The system doses insulin based on CGM sensor glucose levels and the experimental algorithm.
The aim of this clinical study is to determine the efficacy of the MMPPC controller in adolescents and adults with type 1 diabetes in a hotel setting.
This study trials a prototype artificial pancreas system that consists of a Roche insulin pump, a Dexcom continuous glucose monitor (CGM), and an experiential MMPPC (multiple model probabilistic predictive control) algorithm housed on an android cell phone. The system doses insulin based on CGM sensor glucose levels and the experimental algorithm. The algorithm runs through a glucose control platform called the DiAs (Diabetes Assistant)
The aim of this study is to determine the safety and feasibility of the MMPPC controller in adults and adolescents with type 1 diabetes testing the use of predefined tuning parameters to provide adaptability to patient. We will assess the safety of the system with both unannounced meals, and meals using a meal announcement with a premeal insulin bolus based on the subject's estimated carbohydrate content of the meal
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMPPC arm | Experimental | Subjects in this arm will wear the experimental MMPPC algorithm artificial pancreas for 72 hours in a hotel/house setting. The study period will involve unannounced meals and exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMPPC algorithm artificial pancreas | Device | An artificial pancreas system using the MMPPC algorithm, Roche insulin pump, and Dexcom CGM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean CGM glucose value | Average CGm glucose value during the experimental trial | 72 hours |
| CGM percent time < 60 mg/dl | Percent of time the CGM was reading <60 mg/dl | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| CGM percent time < 50 mg/dl | Percent of time the CGM was reading <50 mg/dl | 72 hours |
| CGM percent time < 70 mg/dl | Percent of time the CGM was reading <70 mg/dl |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Announced and Unannounced Meals | Glycemic control in the 4 hour period after announced meals will be compared to glycemic control in the 4 hour period after unannounced meals as an exploratory measure | 72 hours |
| Safety Criteria 1: No more than 3 SMBG values < 50 mg/dL per subject |
3.1 Eligibility Criteria
1. Clinical diagnosis of type 1 diabetes for at least 12 months 2. Daily insulin therapy for at least 12 months 3. Age between 15.0 to 55.0 years of age 4. Use of an insulin pump for at least 3 months 5. Current use of continuous glucose monitoring with Dexcom sensor 6. Subject comprehends English 7. Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test 8. Total daily insulin requirement ≥ 0.3 units/kg/day 9. A1C between 7.0 and 10% 3.2 Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 27, 2023 | |
| Reset | Apr 19, 2023 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 27, 2023 | Apr 19, 2023 |
| 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
Use the MMPPC system for 72 hours in a hotel setting
Not provided
Not provided
Not provided
Not provided
| 72 hours |
| % 70-140 mg/dl | Percent of time CGM glucose levels were between 70-140 mg/dl | 72 hours |
| % 70-180 mg/dl | Percent of time CGM glucose levels were between 70-180 mg/dl | 72 hours |
| % CGM >180 mg/dl | Percent of time CGM glucose levels were >180 mg/dl | 72 hours |
| % CGM >250 mg/dl | Percent of time CGM glucose levels were >250 mg/dl | 72 hours |
| number of SMBG <70 mg/dl | Number of self monitored blood glucose levels less than 70 mg/dl | 72 hours |
| number of SMBG <60 mg/dl | Number of self monitored blood glucose levels less than 60 mg/dl | 72 hours |
| number of SMBG <50 mg/dl | Number of self monitored blood glucose levels less than 50 mg/dl | 72 hours |
| Grams of carbs for hypoglycemia | Number of carbohydrates consumed for treatment of hypoglycemia | 72 hours |
| Total daily dose of insulin | Total daily dose of insulin | 72 hours |
| % time CGM used | Percent of time CGM was used | 72 hours |
| % time in closed loop | Percent of time in closed loop | 72 hours |
| % of subjects with mean CGM <169 (eHbA1C < 7.5%) | Percentage of subjects with mean CGM value < 169 for the 72 hour period. This corresponds to an estimated hemoglobin A1c of <7.5%. | 72 hours |
Safety evaluation of system based on SMBG detected severe hypoglycemia |
| 72 hours |
| Safety Criteria 2: No more than 2 episodes with SMBG value >300 mg/dL for >1 hour not due to infusion set failure per subject | Safety evaluation of system based on SMBG detected hyperglycemia | 72 hours |
| Safety Criteria 3: No kotonemia >1.0 mmol/L, while the system is functional unless related to an intercurrent illness or infusion set failure for any patient | Safety evaluation of system based on ketone detection | 72 hours |
| Safety Criteria 4: No seizures or loss of consciousness while system is on and functional | Safety evaluation of system based on severe hypoglycemic events | 72 hours |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |