MMPPC Outpatient Clinical Protocol 2016
- Conditions
- Type 1 Diabetes
- Interventions
- Device: MMPPC algorithm artificial pancreas
- Registration Number
- NCT02769884
- Lead Sponsor
- Rensselaer Polytechnic Institute
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MMPPC arm MMPPC algorithm artificial pancreas 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
- Primary Outcome Measures
Name Time Method Mean CGM glucose value 72 hours Average CGm glucose value during the experimental trial
CGM percent time < 60 mg/dl 72 hours Percent of time the CGM was reading \<60 mg/dl
- Secondary Outcome Measures
Name Time Method CGM percent time < 50 mg/dl 72 hours Percent of time the CGM was reading \<50 mg/dl
number of SMBG <70 mg/dl 72 hours Number of self monitored blood glucose levels less than 70 mg/dl
Grams of carbs for hypoglycemia 72 hours Number of carbohydrates consumed for treatment of hypoglycemia
CGM percent time < 70 mg/dl 72 hours Percent of time the CGM was reading \<70 mg/dl
% CGM >250 mg/dl 72 hours Percent of time CGM glucose levels were \>250 mg/dl
% time CGM used 72 hours Percent of time CGM was used
% 70-140 mg/dl 72 hours Percent of time CGM glucose levels were between 70-140 mg/dl
number of SMBG <60 mg/dl 72 hours Number of self monitored blood glucose levels less than 60 mg/dl
% CGM >180 mg/dl 72 hours Percent of time CGM glucose levels were \>180 mg/dl
Total daily dose of insulin 72 hours Total daily dose of insulin
% time in closed loop 72 hours Percent of time in closed loop
% of subjects with mean CGM <169 (eHbA1C < 7.5%) 72 hours Percentage of subjects with mean CGM value \< 169 for the 72 hour period. This corresponds to an estimated hemoglobin A1c of \<7.5%.
% 70-180 mg/dl 72 hours Percent of time CGM glucose levels were between 70-180 mg/dl
number of SMBG <50 mg/dl 72 hours Number of self monitored blood glucose levels less than 50 mg/dl