Type 1 Diabetes
Conditions
Keywords
artificial pancreas
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
Interventions
DEVICEMMPPC algorithm artificial pancreas
An artificial pancreas system using the MMPPC algorithm, Roche insulin pump, and Dexcom CGM
Sponsors
Stanford University
University of Colorado, Denver
Mount Sinai Hospital, New York
Rensselaer Polytechnic Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Use the MMPPC system for 72 hours in a hotel setting
Eligibility
Sex/Gender
ALL
Age
15 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
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
1. Diabetic ketoacidosis in the past 6 months 2. Hypoglycemic seizure or loss of consciousness in the past 6 months 3. Hypoglycemia unawareness as defined by no recognition of hypoglycemia until the glucose is \<60 mg/dL and no adrenergic symptoms at glucose of 60 mg/dL (shakiness, palpitations, diaphoresis). Subjects will also be administered the Clark questionnaire for hypoglycemia unawareness. If they have a score ≥ 4, they are excluded from the study 4. Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or glargine) 5. Subjects using other anti-diabetic medications other than insulin (oral or injectable) at the time of enrollment. Any prior use of other anti-diabetic medications must be washed out for at least 8 weeks prior to enrollment. 6. Current use of other medications, which in the judgment of the investigator would be a contraindication to participation in the study 7. Subject has a medical disorder that in the judgment of the investigator will affect completion of any aspect of the protocol 8. Subject is currently participating in another investigational device or drug study within 30 days or 5-half lives of the drug. 9. Subject has a history of any cardiac or vascular disorder including, but not limited to, myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, arrhythmia or thromboembolic disease 10. An EKG will be obtained on subjects who are ≥ 45 years of age, or who have had a 20 year history of diabetes and are ≥ 30 years of age. Subjects will be excluded if they have an abnormal EKG consistent with coronary artery disease or increased risk of malignant arrhythmia including, but not limited to, evidence of active ischemia, prior myocardial infarction, proximal LAD critical stenosis (Wellen's sign), prolonged QT interval (\> 440 ms). Non-specific ST segment and T wave changes are not grounds for exclusion in the absence of symptoms or history of heart disease. 11. Subject has a history of hepatic disease 12. Subject has renal failure on dialysis 13. Systolic blood pressure \> 160 mmHg on screening visit 14. Diastolic blood pressure \> 90 mmHg on screening visit 15. Subjects with inadequately treated thyroid disease or celiac disease 16. Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol 17. Subject has received inpatient psychiatric treatment in the past 6 months 18. Subject consumes more than an average of 4 standard alcoholic drinks/day in the last 30 days 19. Subject has an active skin condition that would affect sensor placement 20. Subject is unable to avoid acetaminophen for the duration of the study 21. Subject consuming less than 100g of carbohydrates daily
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| % CGM >250 mg/dl | 72 hours | Percent of time CGM glucose levels were \>250 mg/dl |
| Grams of carbs for hypoglycemia | 72 hours | Number of carbohydrates consumed for treatment of hypoglycemia |
| Total daily dose of insulin | 72 hours | Total daily dose of insulin |
| % time CGM used | 72 hours | Percent of time CGM was used |
| % 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%. |
| CGM percent time < 50 mg/dl | 72 hours | Percent of time the CGM was reading \<50 mg/dl |
| CGM percent time < 70 mg/dl | 72 hours | Percent of time the CGM was reading \<70 mg/dl |
| % 70-140 mg/dl | 72 hours | Percent of time CGM glucose levels were between 70-140 mg/dl |
| % 70-180 mg/dl | 72 hours | Percent of time CGM glucose levels were between 70-180 mg/dl |
| % CGM >180 mg/dl | 72 hours | Percent of time CGM glucose levels were \>180 mg/dl |
| number of SMBG <70 mg/dl | 72 hours | Number of self monitored blood glucose levels less than 70 mg/dl |
| number of SMBG <60 mg/dl | 72 hours | Number of self monitored blood glucose levels less than 60 mg/dl |
| number of SMBG <50 mg/dl | 72 hours | Number of self monitored blood glucose levels less than 50 mg/dl |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 72 hours | Safety evaluation of system based on ketone detection |
| Safety Criteria 4: No seizures or loss of consciousness while system is on and functional | 72 hours | Safety evaluation of system based on severe hypoglycemic events |
| 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 | 72 hours | Safety evaluation of system based on SMBG detected hyperglycemia |
| Safety Criteria 1: No more than 3 SMBG values < 50 mg/dL per subject | 72 hours | Safety evaluation of system based on SMBG detected severe hypoglycemia |
| Comparison of Announced and Unannounced Meals | 72 hours | 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 |
Outcome results
None listed