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 |
|---|---|
| Harvard University | OTHER |
| Harvard School of Public Health (HSPH) | OTHER |
Not provided
Not provided
Not provided
The objective of this randomized crossover clinical trial is to 1) assess the efficacy and safety of an automated insulin delivery (AID) system using a Model Predictive Control (MPC) algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS) in people with type 1 diabetes, and 2) assess the impact of different meal macronutrient content on glucose control when using AID and SAP.
The goal of this study is to compare the efficacy and safety of an AID system using a MPC algorithm versus SAP/PLGS therapy with different food choices over a 4 week period.
The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices.
In this study, during each two-week period, subjects will be given pre-weighed portions of different meals to eat (either regular semolina pasta or extra-long grain white rice) with detailed cooking instructions, and will eat these meals on 6 different occasions for dinner. They will bolus as they normally do for these meals. This will allow us to observe the postprandial meal response when using sensor-augmented pump (SAP) or iAPS, showing the importance of nutrition choices with modern technological treatments in T1D.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated Insulin Delivery | Experimental | Participants will use the Automated Insulin Delivery (AID) iAPS system for 2 weeks in the outpatient setting. During AID use, subjects will consume 6 study meals (3 meals of each meal type in assigned random order, 1-2 portions per meal,) at dinner time over the 2-week period in a pre-assigned random order, and document on the study meal forms when they consume each numbered meal. |
|
| SAP/PLGS | No Intervention | Participants will use their home pump with a CGM sensor (sensor augmented pump) or in Predictive Low Glucose Suspend (PLGS) mode if their home pump supports this mode, for 2 weeks in the outpatient setting. During these 2 weeks, subjects will consume 6 study meals (3 meals of each meal type in assigned random order, 1-2 portions per meal,) at dinner time over the 2-week period in a pre-assigned random order, and document on the study meal forms when they consume each numbered meal. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iAPS | Device | The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in target glucose range | Time in target glucose range 70-180 mg/dL measured by CGM to determine safety and efficacy of the integrated system | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glucose peak | Postprandial glucose peak rise (highest measurement in mg/dL) from baseline glucose (mg/dl) for the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS | 4 weeks |
| Time to postprandial glucose peak |
| Measure | Description | Time Frame |
|---|---|---|
| Total daily insulin use | Total daily insulin use (units/day) during both use of SAP/PLGS and when using the iAPS | 4 weeks |
| Total basal insulin use | Total daily basal insulin use (units/day) during both use of SAP/PLGS and when using the iAPS |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eyal Dassau, PhD | John A. Paulson School of Engineering and Applied Sciences | Principal Investigator |
| David Eisenberg, MD | Harvard School of Public Health (HSPH) | Principal Investigator |
| Jordan E Pinsker, MD | Sansum Diabetes Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32319791 | Derived | Deshpande S, Pinsker JE, Church MM, Piper M, Andre C, Massa J, Doyle Iii FJ, Eisenberg DM, Dassau E. Randomized Crossover Comparison of Automated Insulin Delivery Versus Conventional Therapy Using an Unlocked Smartphone with Scheduled Pasta and Rice Meal Challenges in the Outpatient Setting. Diabetes Technol Ther. 2020 Dec;22(12):865-874. doi: 10.1089/dia.2020.0022. Epub 2020 Oct 13. |
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
Time (minutes) to postprandial glucose (highest measurement in mg/dL) rise from baseline glucose (mg/dl) during the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS |
| 4 weeks |
| Postprandial Area Under the Curve | Area Under the Curve Glucose (mg/dl x min) for the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS | 4 weeks |
| Postprandial time for glucose to return to baseline | Time (minutes) for CGM glucose to return to baseline (starting value) after the study meals, during both use of SAP/PLGS and when using the iAPS | 4 weeks |
| Glucose < 70 mg/dL | Percent time GGM glucose < 70 mg/dL | 4 weeks |
| Glucose < 54 mg/dL | Percent time GGM glucose < 54 mg/dL | 4 weeks |
| Glucose > 180 mg/dL | Percent time GGM glucose > 180 mg/dL | 4 weeks |
| Glucose > 250 mg/dL | Percent time GGM glucose > 250 mg/dL | 4 weeks |
| Serious adverse events (SAE) | The total number of serious adverse events during the clinical trial | 4 weeks |
| Serious adverse device events (SADE) | The total number of serious adverse events related to the study device use during the clinical trial | 4 weeks |
| Adverse device effects (ADE) | The total number of adverse device effects (ADE) during the clinical trial | 4 weeks |
| Unanticipated adverse device effects (UADE) | The total number of unanticipated adverse device effects (UADE) during the clinical trial | 4 weeks |
| 4 weeks |
| Total bolus insulin use | Total daily bolus insulin use (units/day) during both use of SAP/PLGS and when using the iAPS | 4 weeks |
| Sensor Use Time | Total hours of CGM sensor use time during both use of SAP/PLGS and when using the iAPS | 4 weeks |
| Closed-Loop Active Time | Percent time (hours/day) of closed-loop use during the two weeks of iAPS use | 2 weeks |
| Device Issues | Total number of devices issues during the clinical trial | 4 weeks |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided