Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation

University of Virginia50 enrolled

Overview

The purpose of this study is to test the meal anticipation module on a closed loop algorithm, assessing efficacy and safety.

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; 1. without the meal anticipation module and without carbohydrate announcement (FCL) 2. with the meal anticipation module and without carbohydrate announcement (FCL+) 3. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Fully Closed Loop (FCL)DEVICE

Closed loop without a meal anticipation module without announced carbohydrate

Fully Closed Loop with meal anticipation module (FCL+)DEVICE

Closed loop with a meal anticipation module and without announced carbohydrate

Hybrid Closed Loop (HCL)DEVICE

Closed loop without a meal anticipation module with announced carbohydrate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥18.0 and ≤70 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year 3. Currently using insulin for at least six months 4. Currently using insulin pump for at least three months 5. Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections 6. Access to internet and willingness to upload data during the study as needed 7. For females, not currently known to be pregnant or breastfeeding 8. 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. 9. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use 10. Willingness to use the University of Virginia (UVa) closed-loop system throughout study admission 11. 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) 12. 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) 13. Willingness to eat at least 1g/kg of carbohydrate per day during the hotel admission 14. Willingness to reschedule if placed on oral steroids 15. An understanding and willingness to follow the protocol and signed informed consent 16. 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: 1. History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment 2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment 3. Pregnancy or intent to become pregnant during the trial 4. Currently being treated for a seizure disorder 5. Planned surgery during study duration 6. Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals) 7. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol. 8. Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team 9. Known contact with a COVID-19 positive individual within 14 days of the hotel/rental house studies.

Locations (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

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.

Time frame: The 5 hour period following breakfast during the study admission

Secondary Outcomes

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 frame: The 24 hour study admission from 4pm to 4pm

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 frame: The 5 hour period following dinner during the study admission

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 frame: The 5 hour period following lunch during the study admission

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 frame: The 5 hour period following breakfast during the study admission

Time Below Range (TBR) Overall

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

Data from ClinicalTrials.gov

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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 frame: The 5 hour period following dinner during the study admission

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 frame: The 5 hour period following lunch during the study admission

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 frame: The 5 hour period following breakfast during the study admission

Time Above Range (TAR) Overall

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

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 frame: The 5 hour period following dinner during the study admission

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 frame: The 5 hour period following lunch during the study admission

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 frame: The 5 hour period following breakfast during the study admission

Time in Significant Hyperglycemia Overall

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

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 frame: The 5 hour period following dinner during the study admission

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 frame: The 5 hour period following lunch during the study admission

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 frame: The 5 hour period following breakfast during the study admission

Time in Significant Hypoglycemia Overall

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

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 frame: The 5 hour period following dinner during the study admission

Time in Significant Hypoglycemia Lunch Time + 5 Hours

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

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.

Time frame: The 5 hour period following breakfast during the study admission

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.

Time frame: The 24 hour study admission from 4pm to 4pm

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.

Time frame: The 5 hour period following dinner during the study admission

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).

Time frame: The 5 hour period following lunch during the study admission

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

Time frame: The 7 hour period including the two hours before and the 5 hours after breakfast

Units of Insulin Injected (Units/kg) Overall

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

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

Time frame: The 7 hour period including the 2 hours before and 5 hours after dinner