Diabetes Mellitus, Hyperglycemia
Conditions
Keywords
Closed-loop blood glucose control, Continuous glucose monitoring, Bionic pancreas, Artificial pancreas
Brief summary
The purpose of this study is to test an experimental medical device designed to automatically control blood sugar. This device was designed for use by patients with diabetes while they are in the hospital, and others who may develop high blood sugar as a result of their medical problems.
Detailed description
The goal of this first-in-man trial is to test the safety and efficacy of the automated, closed-loop control system in insulin sensitive subjects with type 1 diabetes, insulin sensitive subjects with type 2 diabetes (TTD \> 1u/kg/day), and subjects with type 2 diabetes and substantial insulin resistance (\<2 u/kg/day). The results of this study will help to design future studies, exploring the use of the closed-loop system for BG control in hospitalized patients, including those with diabetes or hyperglycemia of critical illness.
Interventions
DEVICEClosed-loop blood glucose control
The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose \> 2 u/kg).
Sponsors
Boston University
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Subjects with type 1 diabetes * Age 21 to 75 with clinical type 1 diabetes for at least one year * Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins * Total daily dose (TDD) of insulin that is \< 1 u/kg Subjects with type 2 diabetes * Age 21 to 75 with clinical type 2 diabetes for at least one year * Diabetes managed using NPH as the basal insulin, which may be supplemented with regular or rapid-acting insulin * Total daily dose (TDD) of insulin that is \> 1 u/kg/day but \< 2 u/kg/day or \> 2 u/kg/day
Exclusion criteria
* Pregnancy * Renal insufficiency * Cancer * Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia * Acute illness or exacerbation of chronic illness at the time of the study procedure * Use of non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications other than metformin * History of allergy or adverse reaction to aspirin, peptic ulcers or bleeding disorders * Known history of coronary artery disease, TIA or stroke * History of seizures * Transaminitis * Stage 2 hypertension at the time of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements. | 12 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements | 12 hours | — |
| Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl | 12 hours | — |
| Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm | 12 hours | — |
| Number of BG Events < 70 mg/dl as Determined by the CGM | 12 hours | — |
| Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol | 12 hours | — |
| Insulin Dosing (u/kg) | 12 hours | — |
| Dextrose Dosing (g/kg) | 12 hours | — |
| Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard. | 12 hours | The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout |
| Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl | 12 hours | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Closed-loop Blood Glucose Control | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Closed-loop Blood Glucose Control |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.
Time frame: 12 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-loop Blood Glucose Control | Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements. | Overall average blood sugar | 115.9 mg/dl | Standard Deviation 19.7 |
| Closed-loop Blood Glucose Control | Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements. | Type 1 subjects average blood sugar | 107.0 mg/dl | Standard Deviation 13.6 |
| Closed-loop Blood Glucose Control | Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements. | Type 2 subjects average blood sugar | 124.83 mg/dl | Standard Deviation 21.85 |
Secondary
Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard.
The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed-loop Blood Glucose Control | Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard. | 8.29 percent absolute relative difference | Standard Deviation 7.41 |
Secondary
Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed-loop Blood Glucose Control | Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm | 115.8 mg/dl | Standard Deviation 21.4 |
Secondary
Dextrose Dosing (g/kg)
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed-loop Blood Glucose Control | Dextrose Dosing (g/kg) | 0.48 grams/kilogram | Standard Deviation 0.45 |
Secondary
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl
Time frame: 12 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-loop Blood Glucose Control | Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl | 70-180 mg/dl | 95.5 percentage of time | Standard Deviation 7.6 |
| Closed-loop Blood Glucose Control | Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl | 70-120 mg/dl | 67.5 percentage of time | Standard Deviation 27.7 |
| Closed-loop Blood Glucose Control | Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl | < 70 mg/dl | 0.25 percentage of time | Standard Deviation 0.45 |
| Closed-loop Blood Glucose Control | Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl | > 180 mg/dl | 4.3 percentage of time | Standard Deviation 7.8 |
Secondary
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl
Time frame: 12 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-loop Blood Glucose Control | Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl | < 70 mg/dl | 1.5 percentage of time | Standard Deviation 3 |
| Closed-loop Blood Glucose Control | Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl | 70-120 mg/dl | 66.8 percentage of time | Standard Deviation 26.4 |
| Closed-loop Blood Glucose Control | Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl | 70-180 mg/dl | 94.4 percentage of time | Standard Deviation 6.9 |
| Closed-loop Blood Glucose Control | Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl | > 180 mg/dl | 4.0 percentage of time | Standard Deviation 7.3 |
Secondary
Insulin Dosing (u/kg)
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed-loop Blood Glucose Control | Insulin Dosing (u/kg) | 0.42 units/kilogram | Standard Deviation 0.28 |
Secondary
Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements
Time frame: 12 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed-loop Blood Glucose Control | Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements | 4 Blood glucose values < 70 mg/dl |
Secondary
Number of BG Events < 70 mg/dl as Determined by the CGM
Time frame: 12 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed-loop Blood Glucose Control | Number of BG Events < 70 mg/dl as Determined by the CGM | 8 events |
Secondary
Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol
Time frame: 12 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed-loop Blood Glucose Control | Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol | 0 number of carbohydrate interventions |