Back to resultsDiabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fully Closed Loop (FCL)
Fully Closed Loop with meal anticipation module (FCL+)
Hybrid Closed Loop (HCL)
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes (T1D), Continuous Glucose Monitor (CGM), Insulin Pump, Fully Automated Closed Loop (FCL), Hybrid Closed Loop (HCL)
Eligibility Criteria
Inclusion Criteria:
- Age ≥18.0 and ≤70 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 University of Virginia (UVa) closed-loop system throughout study admission
- Willingness to use the insulin supplied by the study for the hotel stay, if not already using that preparation. Study insulin will be lispro (Humalog) or aspart (Novolog)
- 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 1g/kg of carbohydrate per day during the hotel admission
- Willingness to reschedule if placed on oral steroids
- An understanding and willingness to follow the protocol and signed informed consent
- Willingness to commit to self-quarantine for at least 5 days before COVID-19 testing (If participant has received a full course of COVID-19 vaccine and data emerge suggesting significantly reduced transmissibility among those receiving that vaccine, this self-quarantine requirement can be waived.)
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
- Known contact with a COVID-19 positive individual within 14 days of the hotel/rental house studies.
Sites / Locations
- University of Virginia Center for Diabetes Technology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
FCL (Fully Closed Loop)
FCL+ (Fully Closed Loop with meal anticipation)
HCL (Hybrid Closed Loop)
Arm Description
Closed-loop control without meal anticipation module without meal bolus
Closed-loop control with meal anticipation module without meal bolus
Closed-loop control without meal anticipation module with meal bolus
Outcomes
Primary Outcome Measures
Time in Range (TIR) 70-180 mg/dL From Breakfast Time + 5 Hours
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following breakfast. Higher TIR is a positive outcome.
Secondary Outcome Measures
Time in Range (TIR) 70-180 mg/dL Overall
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) during the 24hr study admission. Higher TIR is a positive outcome.
Time in Range (TIR) 70-180 mg/dL From Dinner Time + 5 Hours
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following dinner. Higher TIR is a positive outcome.
Time in Range (TIR) 70-180 mg/dL From Lunch Time + 5 Hours
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following lunch. Higher TIR is a positive outcome.
Time Below Range (TBR) From Breakfast Time + 5 Hours
Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following breakfast.
Time Below Range (TBR) Overall
Frequency of CGM values falling below 70 mg/dL (excluded) during the 24hr study admission.
Time Below Range (TBR) From Dinner Time + 5 Hours
Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following dinner.
Time Below Range (TBR) From Lunch Time + 5 Hours
Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following lunch.
Time Above Range (TAR) From Breakfast Time + 5 Hours
Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following breakfast.
Time Above Range (TAR) Overall
Frequency of CGM values falling above 180 mg/dL (excluded) during the 24hr study admission.
Time Above Range (TAR) From Dinner Time + 5 Hours
Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following dinner.
Time Above Range (TAR) From Lunch Time + 5 Hours
Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following lunch.
Time in Significant Hyperglycemia From Breakfast Time + 5 Hours
Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following breakfast.
Time in Significant Hyperglycemia Overall
Frequency of CGM values falling above 250 mg/dL (excluded) during the 24hr study admission.
Time in Significant Hyperglycemia From Dinner Time + 5 Hours
Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following dinner.
Time in Significant Hyperglycemia From Lunch Time + 5 Hours
Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following lunch.
Time in Significant Hypoglycemia From Breakfast Time +5 Hours
Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following breakfast.
Time in Significant Hypoglycemia Overall
Frequency of CGM values falling below 54 mg/dL (excluded) during the 24hr study admission.
Time in Significant Hypoglycemia Dinner Time + 5 Hours
Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following dinner.
Time in Significant Hypoglycemia Lunch Time + 5 Hours
Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following lunch
Number of Hypoglycemia Events From Breakfast Time + 5 Hours
Number of hypoglycemia events in the 5 hours following breakfast. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Metrics are number of hypoglycemia events per participant.
Number of Hypoglycemia Events Overall
Number of hypoglycemia events during the 24hr study admission. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Values reported as the number of hypoglycemia events per participant.
Number of Hypoglycemia Events Dinner Time + 5 Hours
Number of hypoglycemia events in the 5 hours following dinner. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Values reported as the number of hypoglycemia events per participant.
Number of Hypoglycemia Events Lunch Time + 5 Hours
Number of hypoglycemia events in the 5 hours following lunch. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one).
Units of Insulin Injected Between 2 Hours Before and 5 Hours After Breakfast
Sum of all system provided insulin for breakfast (as planned) post-prandial excursion, including anticipation
Units of Insulin Injected (Units/kg) Overall
Calculation of all system-provided insulin (units/kg) injected during the 24hr study admission.
Units of Insulin Injected Between 2 Hours Before and 5 Hours After Dinner
Sum of all system provided insulin for dinner (late) post-prandial excursion, including anticipation
Full Information
NCT ID
NCT04877730
First Posted
April 26, 2021
Last Updated
April 21, 2023
Sponsor
University of Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04877730
Brief Title
Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation
Official Title
Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
March 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
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 purpose of this study is to test the meal anticipation module on a closed loop algorithm, assessing efficacy and safety.
Detailed Description
This is a pilot study to assess glycemic responses to three different approaches to insulin dosing for carbohydrate ingestion, with different approaches to a closed-loop system in random order;
without the meal anticipation module and without carbohydrate announcement (FCL)
with the meal anticipation module and without carbohydrate announcement (FCL+)
without the meal anticipation module and with carbohydrate announcement (HCL),
This study will target completion of up to 36 adults in a randomized cross-over trial, comparing blood glucose time in range 70-180 mg/dL following meals with and without the meal anticipation module in use (FCL+ vs FCL), and comparing to a system with carb announcement instead of a meal anticipation module (HCL). The study will also assess safety when dinner is consumed later than usual and when a lunch is consumed without having been entrained in the meal anticipation module. Each participant will complete each of the 3 modules in random order.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 Diabetes (T1D), Continuous Glucose Monitor (CGM), Insulin Pump, Fully Automated Closed Loop (FCL), Hybrid Closed Loop (HCL)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FCL (Fully Closed Loop)
Arm Type
Experimental
Arm Description
Closed-loop control without meal anticipation module without meal bolus
Arm Title
FCL+ (Fully Closed Loop with meal anticipation)
Arm Type
Experimental
Arm Description
Closed-loop control with meal anticipation module without meal bolus
Arm Title
HCL (Hybrid Closed Loop)
Arm Type
Experimental
Arm Description
Closed-loop control without meal anticipation module with meal bolus
Intervention Type
Device
Intervention Name(s)
Fully Closed Loop (FCL)
Intervention Description
Closed loop without a meal anticipation module without announced carbohydrate
Intervention Type
Device
Intervention Name(s)
Fully Closed Loop with meal anticipation module (FCL+)
Intervention Description
Closed loop with a meal anticipation module and without announced carbohydrate
Intervention Type
Device
Intervention Name(s)
Hybrid Closed Loop (HCL)
Intervention Description
Closed loop without a meal anticipation module with announced carbohydrate
Primary Outcome Measure Information:
Title
Time in Range (TIR) 70-180 mg/dL From Breakfast Time + 5 Hours
Description
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following breakfast. Higher TIR is a positive outcome.
Time Frame
The 5 hour period following breakfast during the study admission
Secondary Outcome Measure Information:
Title
Time in Range (TIR) 70-180 mg/dL Overall
Description
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) during the 24hr study admission. Higher TIR is a positive outcome.
Time Frame
The 24 hour study admission from 4pm to 4pm
Title
Time in Range (TIR) 70-180 mg/dL From Dinner Time + 5 Hours
Description
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following dinner. Higher TIR is a positive outcome.
Time Frame
The 5 hour period following dinner during the study admission
Title
Time in Range (TIR) 70-180 mg/dL From Lunch Time + 5 Hours
Description
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following lunch. Higher TIR is a positive outcome.
Time Frame
The 5 hour period following lunch during the study admission
Title
Time Below Range (TBR) From Breakfast Time + 5 Hours
Description
Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following breakfast.
Time Frame
The 5 hour period following breakfast during the study admission
Title
Time Below Range (TBR) Overall
Description
Frequency of CGM values falling below 70 mg/dL (excluded) during the 24hr study admission.
Time Frame
The 24 hour study admission from 4pm to 4pm
Title
Time Below Range (TBR) From Dinner Time + 5 Hours
Description
Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following dinner.
Time Frame
The 5 hour period following dinner during the study admission
Title
Time Below Range (TBR) From Lunch Time + 5 Hours
Description
Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following lunch.
Time Frame
The 5 hour period following lunch during the study admission
Title
Time Above Range (TAR) From Breakfast Time + 5 Hours
Description
Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following breakfast.
Time Frame
The 5 hour period following breakfast during the study admission
Title
Time Above Range (TAR) Overall
Description
Frequency of CGM values falling above 180 mg/dL (excluded) during the 24hr study admission.
Time Frame
The 24 hour study admission from 4pm to 4pm
Title
Time Above Range (TAR) From Dinner Time + 5 Hours
Description
Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following dinner.
Time Frame
The 5 hour period following dinner during the study admission
Title
Time Above Range (TAR) From Lunch Time + 5 Hours
Description
Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following lunch.
Time Frame
The 5 hour period following lunch during the study admission
Title
Time in Significant Hyperglycemia From Breakfast Time + 5 Hours
Description
Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following breakfast.
Time Frame
The 5 hour period following breakfast during the study admission
Title
Time in Significant Hyperglycemia Overall
Description
Frequency of CGM values falling above 250 mg/dL (excluded) during the 24hr study admission.
Time Frame
The 24 hour study admission from 4pm to 4pm
Title
Time in Significant Hyperglycemia From Dinner Time + 5 Hours
Description
Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following dinner.
Time Frame
The 5 hour period following dinner during the study admission
Title
Time in Significant Hyperglycemia From Lunch Time + 5 Hours
Description
Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following lunch.
Time Frame
The 5 hour period following lunch during the study admission
Title
Time in Significant Hypoglycemia From Breakfast Time +5 Hours
Description
Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following breakfast.
Time Frame
The 5 hour period following breakfast during the study admission
Title
Time in Significant Hypoglycemia Overall
Description
Frequency of CGM values falling below 54 mg/dL (excluded) during the 24hr study admission.
Time Frame
The 24 hour study admission from 4pm to 4pm
Title
Time in Significant Hypoglycemia Dinner Time + 5 Hours
Description
Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following dinner.
Time Frame
The 5 hour period following dinner during the study admission
Title
Time in Significant Hypoglycemia Lunch Time + 5 Hours
Description
Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following lunch
Time Frame
The 5 hour period following lunch during the study admission
Title
Number of Hypoglycemia Events From Breakfast Time + 5 Hours
Description
Number of hypoglycemia events in the 5 hours following breakfast. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Metrics are number of hypoglycemia events per participant.
Time Frame
The 5 hour period following breakfast during the study admission
Title
Number of Hypoglycemia Events Overall
Description
Number of hypoglycemia events during the 24hr study admission. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Values reported as the number of hypoglycemia events per participant.
Time Frame
The 24 hour study admission from 4pm to 4pm
Title
Number of Hypoglycemia Events Dinner Time + 5 Hours
Description
Number of hypoglycemia events in the 5 hours following dinner. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Values reported as the number of hypoglycemia events per participant.
Time Frame
The 5 hour period following dinner during the study admission
Title
Number of Hypoglycemia Events Lunch Time + 5 Hours
Description
Number of hypoglycemia events in the 5 hours following lunch. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one).
Time Frame
The 5 hour period following lunch during the study admission
Title
Units of Insulin Injected Between 2 Hours Before and 5 Hours After Breakfast
Description
Sum of all system provided insulin for breakfast (as planned) post-prandial excursion, including anticipation
Time Frame
The 7 hour period including the two hours before and the 5 hours after breakfast
Title
Units of Insulin Injected (Units/kg) Overall
Description
Calculation of all system-provided insulin (units/kg) injected during the 24hr study admission.
Time Frame
The 24 hour study admission from 4pm to 4pm
Title
Units of Insulin Injected Between 2 Hours Before and 5 Hours After Dinner
Description
Sum of all system provided insulin for dinner (late) post-prandial excursion, including anticipation
Time Frame
The 7 hour period including the 2 hours before and 5 hours after dinner
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18.0 and ≤70 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 University of Virginia (UVa) closed-loop system throughout study admission
Willingness to use the insulin supplied by the study for the hotel stay, if not already using that preparation. Study insulin will be lispro (Humalog) or aspart (Novolog)
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 1g/kg of carbohydrate per day during the hotel admission
Willingness to reschedule if placed on oral steroids
An understanding and willingness to follow the protocol and signed informed consent
Willingness to commit to self-quarantine for at least 5 days before COVID-19 testing (If participant has received a full course of COVID-19 vaccine and data emerge suggesting significantly reduced transmissibility among those receiving that vaccine, this self-quarantine requirement can be waived.)
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
Known contact with a COVID-19 positive individual within 14 days of the hotel/rental house studies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Brown, MD
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
22903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
IPD Sharing Time Frame
Generally data will be made available after the primary publications of each study.
IPD Sharing Access Criteria
Data Sharing agreements will be formulated by the study team.
Learn more about this trial
Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation
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