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Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes (RocketAP)

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

RocketAP

USS Virginia

About this trial

This is an interventional other trial for Type 1 Diabetes focused on measuring Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Insulin Pump, Closed Loop Control

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥12.0 and ≤25 years old at time of consent
Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
Currently using insulin for at least six months
Currently using insulin pump for at least three months
Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
Access to internet and willingness to upload data during the study as needed
For females, not currently known to be pregnant or breastfeeding
If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
Willingness to use the UVa artificial pancreas system throughout study sessions.
Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/d
Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals)
Willingness to eat at least 1 g/kg of carbohydrate per day during the camp/hotel admission
Willingness to reschedule Study Dinner Sessions if placed on oral steroids
An understanding and willingness to follow the protocol and signed informed consent

Exclusion Criteria:

History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
Pregnancy or intent to become pregnant during the trial
Currently being treated for a seizure disorder
Planned surgery during study duration
Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team

Sites / Locations

University of Virginia Center for Diabetes Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RocketAP

USS Virginia

Arm Description

Adolescents will be assessed for a 48-70 hour period on the Rocket AP. This time will include two dinner times, one with and one without announcement of carbohydrate content. This is a cross-over study, so all participants will also be tested on the USS Virginia system under the same conditions.

Adolescents will be assessed for a 48-70 hour period on the USS Virginia system. This time will include two dinner times, one with and one without announcement of carbohydrate content. This is a cross-over study, so all participants will also be tested on the Rocket AP system under the same conditions.

Outcomes

Primary Outcome Measures

Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range 70-180 mg/dL in the Unannounced Meal

Percentage of time from dinner time until midnight with blood glucose in range 70-180 mg/dL in the unannounced meal

Secondary Outcome Measures

Number of Hypoglycemia Events From Dinner Time Until Midnight

Number of hypoglycemia events from dinner time until midnight

Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL

Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL

Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL

Units of Insulin Injected From Dinner Time Until Midnight

Units of insulin injected from dinner time until midnight

The Blood Glucose Area Under the Curve (AUC) From Dinner Until Midnight, Accounting for the Initial Blood Glucose Value

The blood glucose area under the curve (AUC) from dinner until midnight, accounting for the initial blood glucose value.

Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range 70-180 mg/dL

Percentage of time from dinner time until dinner time + 12h with blood glucose in range 70-180 mg/dL

Number of Hypoglycemia Events From Dinner Time Until Dinner Time + 12h

Number of hypoglycemia events from dinner Time until dinner time + 12h

Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range <70 mg/dL

Percentage of time from dinner time until dinner time + 12h with blood Glucose in range <70 mg/dL

Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >180 mg/dL

Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL

Units of Insulin Injected From Dinner Time Until Dinner Time + 12h

Units of insulin injected from dinner time until dinner time + 12h

The Blood Glucose Area Under the Curve (AUC) From Dinner Until Dinner + 12h, Accounting for the Initial Blood Glucose Value

The Blood Glucose Area Under the Curve (AUC) From Dinner Until dinner + 12h, Accounting for the Initial Blood Glucose Value

Percentage of Time Outside the Dinner Sessions With Blood Glucose in Range 70-180 mg/dL

Percentage of Time outside the dinner sessions With Blood Glucose in Range 70-180 mg/dL

Number of Hypoglycemia Events Outside of the Study Dinner Sessions

Number of hypoglycemia events outside of the Study Dinner Sessions

Percentage of Time Outside of the Study Dinner Sessions With Blood Glucose <70 mg/dL

Percentage of Time outside of the Study Dinner Sessions with Blood Glucose <70 mg/dL

Percent of Time Outside of the Study Dinner Sessions With Blood Glucose >180 mg/dL

Percent of Time Outside of the Study Dinner Sessions with Blood Glucose >180 mg/dL

Percent Time Outside of the Study Dinner Sessions With Blood Glucose >250 mg/dL

Percent Time Outside of the Study Dinner Sessions with Blood Glucose >250 mg/dL

Units of Insulin Injected Outside of the Study Dinner Sessions

Units of insulin injected outside of the Study Dinner Sessions

Full Information

NCT ID

NCT04545567

First Posted

September 3, 2020

Last Updated

March 31, 2022

Sponsor

University of Virginia

1. Study Identification

Unique Protocol Identification Number

NCT04545567

Brief Title

Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes

Acronym

RocketAP

Official Title

Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes (Rocket AP)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

December 16, 2020 (Actual)

Primary Completion Date

January 18, 2021 (Actual)

Study Completion Date

January 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study team will be comparing two investigational Artificial Pancreas (AP) systems that the UVA Center for Diabetes Technology has developed. An artificial pancreas system delivers insulin automatically based on a blood glucose level that is provided from a continuous glucose monitor (CGM).

Detailed Description

Maintaining blood glucose (BG) control among adolescents with Type 1 diabetes (T1D) is arguably the greatest challenge in the entire field of T1D. One reason for this poor control relates to missed meal boluses, which affects 65% of adolescents at least once weekly, with 38% missing at least 15% of their boluses. Adolescents who miss four boluses weekly experience an increase of 1% in their HbA1c. While the advent of the artificial pancreas (AP) offers promise of safe reductions in HbA1c, the study team previously found that the AP only partly compensates for missed prandial insulin -demonstrating that some form of meal announcement is necessary for good BG control, even with an AP. One way to automate this process is by sharing the prandial dosing responsibilities between an automated insulin priming (based on continuous glucose monitor condition predictive of a safe situation for such insulin dosing) and a closed loop controller capable of reconstructing (estimating) the prevailing glucose rate of appearance from an unannounced meal. The study team has developed such an insulin priming schema and integrated it into a new version of the robust Model Predictive Controller University of Virginia AP system (called the RocketAP). In the current study, the investigators are testing this new AP system in two configurations: hybrid and fully automated, among up to 20 adolescents. The primary outcome will be one of efficacy in assessing how well the new system controls post-prandial BG in the absence of carbohydrate (CHO) announcement as compared to the same situation but using the Control-IQ closed loop algorithm, also designed at UVa and using the same modular architecture and safety system, but without insulin priming and with a less advanced model-based controller. Further comparisons will be made to BG control on RocketAP with CHO announcement and on Control-IQ with CHO announcement. Adolescents will be started on the respective University of Virginia AP systems (RocketAP and Control-IQ in random order, both implemented on the DiAs platform, MAF 2109) and followed over the course of two dinners on each of the two platforms: a dinner where CHO is announced as normal and the 2nd where no announcement is made. The study team hypothesize that performances of RocketAP in fully automated mode will lie in between Hybrid and Fully Automated Control-IQ. In time, this may provide an opportunity to improve BG control among adolescents who miss meal announcement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Insulin Pump, Closed Loop Control

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

A randomized cross-over trial assessing glycemic responses to two different approaches to insulin dosing for carbohydrate ingestion (announced vs. unannounced), with two different AP systems (RocketAP vs. USS Virginia, aka Control-IQ, in random order)

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RocketAP

Arm Type

Experimental

Arm Description

Arm Title

USS Virginia

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

RocketAP

Intervention Description

Artificial pancreas system which is designed to be able to identify when you have eaten and provide insulin for this meal

Intervention Type

Device

Intervention Name(s)

USS Virginia

Intervention Description

Artificial pancreas system which responds to glucose fluctuations by modulating insulin delivery but does not specifically detect meal ingestion

Primary Outcome Measure Information:

Title

Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range 70-180 mg/dL in the Unannounced Meal

Description

Percentage of time from dinner time until midnight with blood glucose in range 70-180 mg/dL in the unannounced meal

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

Number of Hypoglycemia Events From Dinner Time Until Midnight

Description

Number of hypoglycemia events from dinner time until midnight

Time Frame

6 hours

Title

Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL

Description

Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL

Time Frame

6 hours

Title

Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL

Description

Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL

Time Frame

6 hours

Title

Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL

Description

Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL

Time Frame

6 hours

Title

Units of Insulin Injected From Dinner Time Until Midnight

Description

Units of insulin injected from dinner time until midnight

Time Frame

6 hours

Title

The Blood Glucose Area Under the Curve (AUC) From Dinner Until Midnight, Accounting for the Initial Blood Glucose Value

Description

The blood glucose area under the curve (AUC) from dinner until midnight, accounting for the initial blood glucose value.

Time Frame

6 hours

Title

Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range 70-180 mg/dL

Description

Percentage of time from dinner time until dinner time + 12h with blood glucose in range 70-180 mg/dL

Time Frame

12 hours

Title

Number of Hypoglycemia Events From Dinner Time Until Dinner Time + 12h

Description

Number of hypoglycemia events from dinner Time until dinner time + 12h

Time Frame

12 hours

Title

Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range <70 mg/dL

Description

Percentage of time from dinner time until dinner time + 12h with blood Glucose in range <70 mg/dL

Time Frame

12 hours

Title

Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >180 mg/dL

Description

Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >180 mg/dL

Time Frame

12 hours

Title

Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL

Description

Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL

Time Frame

12 hours

Title

Units of Insulin Injected From Dinner Time Until Dinner Time + 12h

Description

Units of insulin injected from dinner time until dinner time + 12h

Time Frame

12 hours

Title

The Blood Glucose Area Under the Curve (AUC) From Dinner Until Dinner + 12h, Accounting for the Initial Blood Glucose Value

Description

The Blood Glucose Area Under the Curve (AUC) From Dinner Until dinner + 12h, Accounting for the Initial Blood Glucose Value

Time Frame

12 hours

Title

Percentage of Time Outside the Dinner Sessions With Blood Glucose in Range 70-180 mg/dL

Description

Percentage of Time outside the dinner sessions With Blood Glucose in Range 70-180 mg/dL

Time Frame

36 hours

Title

Number of Hypoglycemia Events Outside of the Study Dinner Sessions

Description

Number of hypoglycemia events outside of the Study Dinner Sessions

Time Frame

36 hours

Title

Percentage of Time Outside of the Study Dinner Sessions With Blood Glucose <70 mg/dL

Description

Percentage of Time outside of the Study Dinner Sessions with Blood Glucose <70 mg/dL

Time Frame

36 hours

Title

Percent of Time Outside of the Study Dinner Sessions With Blood Glucose >180 mg/dL

Description

Percent of Time Outside of the Study Dinner Sessions with Blood Glucose >180 mg/dL

Time Frame

36 hours

Title

Percent Time Outside of the Study Dinner Sessions With Blood Glucose >250 mg/dL

Description

Percent Time Outside of the Study Dinner Sessions with Blood Glucose >250 mg/dL

Time Frame

36 hours

Title

Units of Insulin Injected Outside of the Study Dinner Sessions

Description

Units of insulin injected outside of the Study Dinner Sessions

Time Frame

36 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥12.0 and ≤25 years old at time of consent Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year Currently using insulin for at least six months Currently using insulin pump for at least three months Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections Access to internet and willingness to upload data during the study as needed For females, not currently known to be pregnant or breastfeeding If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use Willingness to use the UVa artificial pancreas system throughout study sessions. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/d Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals) Willingness to eat at least 1 g/kg of carbohydrate per day during the camp/hotel admission Willingness to reschedule Study Dinner Sessions if placed on oral steroids An understanding and willingness to follow the protocol and signed informed consent Exclusion Criteria: History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment Pregnancy or intent to become pregnant during the trial Currently being treated for a seizure disorder Planned surgery during study duration Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals) A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol. Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark D DeBoer, MD, MSc, MCR

Organizational Affiliation

University of Virginia Center for Diabetes Technology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia Center for Diabetes Technology

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22904

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pending

IPD Sharing Time Frame

Generally will be available after publications completed.

IPD Sharing Access Criteria

No restrictions for access.

Citations:

PubMed Identifier

34400480

Citation

Garcia-Tirado J, Diaz JL, Esquivel-Zuniga R, Koravi CLK, Corbett JP, Dawson M, Wakeman C, Barnett CL, Oliveri MC, Myers H, Krauthause K, Breton MD, DeBoer MD. Advanced Closed-Loop Control System Improves Postprandial Glycemic Control Compared With a Hybrid Closed-Loop System Following Unannounced Meal. Diabetes Care. 2021 Aug 15:dc210932. doi: 10.2337/dc21-0932. Online ahead of print.

Results Reference

result

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Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes

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