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

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ClinicalTrials.gov Identifier: NCT04877730
Recruitment Status : Completed
First Posted : May 7, 2021
Results First Posted : May 17, 2023
Last Update Posted : May 17, 2023
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Sue Brown, University of Virginia

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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Fully Closed Loop (FCL) Device: Fully Closed Loop with meal anticipation module (FCL+) Device: Hybrid Closed Loop (HCL) Not Applicable

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;

  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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation
Actual Study Start Date : May 21, 2021
Actual Primary Completion Date : March 4, 2022
Actual Study Completion Date : March 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: FCL (Fully Closed Loop)
Closed-loop control without meal anticipation module without meal bolus
 Device: Fully Closed Loop (FCL)
Closed loop without a meal anticipation module without announced carbohydrate
Experimental: FCL+ (Fully Closed Loop with meal anticipation)
Closed-loop control with meal anticipation module without meal bolus
 Device: Fully Closed Loop with meal anticipation module (FCL+)
Closed loop with a meal anticipation module and without announced carbohydrate
Experimental: HCL (Hybrid Closed Loop)
Closed-loop control without meal anticipation module with meal bolus
 Device: Hybrid Closed Loop (HCL)
Closed loop without a meal anticipation module with announced carbohydrate


Outcome Measures
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Primary Outcome Measures :
  1. Time in Range (TIR) 70-180 mg/dL From Breakfast Time + 5 Hours [ Time Frame: The 5 hour period following breakfast during the study admission ]
    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 :
  1. Time in Range (TIR) 70-180 mg/dL Overall [ Time Frame: The 24 hour study admission from 4pm to 4pm ]
    Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) during the 24hr study admission. Higher TIR is a positive outcome.

  2. Time in Range (TIR) 70-180 mg/dL From Dinner Time + 5 Hours [ Time Frame: The 5 hour period following dinner during the study admission ]
    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.

  3. Time in Range (TIR) 70-180 mg/dL From Lunch Time + 5 Hours [ Time Frame: The 5 hour period following lunch during the study admission ]
    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.

  4. Time Below Range (TBR) From Breakfast Time + 5 Hours [ Time Frame: The 5 hour period following breakfast during the study admission ]
    Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following breakfast.

  5. Time Below Range (TBR) Overall [ Time Frame: The 24 hour study admission from 4pm to 4pm ]
    Frequency of CGM values falling below 70 mg/dL (excluded) during the 24hr study admission.

  6. Time Below Range (TBR) From Dinner Time + 5 Hours [ Time Frame: The 5 hour period following dinner during the study admission ]
    Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following dinner.

  7. Time Below Range (TBR) From Lunch Time + 5 Hours [ Time Frame: The 5 hour period following lunch during the study admission ]
    Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following lunch.

  8. Time Above Range (TAR) From Breakfast Time + 5 Hours [ Time Frame: The 5 hour period following breakfast during the study admission ]
    Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following breakfast.

  9. Time Above Range (TAR) Overall [ Time Frame: The 24 hour study admission from 4pm to 4pm ]
    Frequency of CGM values falling above 180 mg/dL (excluded) during the 24hr study admission.

  10. Time Above Range (TAR) From Dinner Time + 5 Hours [ Time Frame: The 5 hour period following dinner during the study admission ]
    Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following dinner.

  11. Time Above Range (TAR) From Lunch Time + 5 Hours [ Time Frame: The 5 hour period following lunch during the study admission ]
    Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following lunch.

  12. Time in Significant Hyperglycemia From Breakfast Time + 5 Hours [ Time Frame: The 5 hour period following breakfast during the study admission ]
    Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following breakfast.

  13. Time in Significant Hyperglycemia Overall [ Time Frame: The 24 hour study admission from 4pm to 4pm ]
    Frequency of CGM values falling above 250 mg/dL (excluded) during the 24hr study admission.

  14. Time in Significant Hyperglycemia From Dinner Time + 5 Hours [ Time Frame: The 5 hour period following dinner during the study admission ]
    Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following dinner.

  15. Time in Significant Hyperglycemia From Lunch Time + 5 Hours [ Time Frame: The 5 hour period following lunch during the study admission ]
    Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following lunch.

  16. Time in Significant Hypoglycemia From Breakfast Time +5 Hours [ Time Frame: The 5 hour period following breakfast during the study admission ]
    Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following breakfast.

  17. Time in Significant Hypoglycemia Overall [ Time Frame: The 24 hour study admission from 4pm to 4pm ]
    Frequency of CGM values falling below 54 mg/dL (excluded) during the 24hr study admission.

  18. Time in Significant Hypoglycemia Dinner Time + 5 Hours [ Time Frame: The 5 hour period following dinner during the study admission ]
    Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following dinner.

  19. Time in Significant Hypoglycemia Lunch Time + 5 Hours [ Time Frame: The 5 hour period following lunch during the study admission ]
    Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following lunch

  20. Number of Hypoglycemia Events From Breakfast Time + 5 Hours [ Time Frame: The 5 hour period following breakfast during the study admission ]
    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.

  21. Number of Hypoglycemia Events Overall [ Time Frame: The 24 hour study admission from 4pm to 4pm ]
    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.

  22. Number of Hypoglycemia Events Dinner Time + 5 Hours [ Time Frame: The 5 hour period following dinner during the study admission ]
    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.

  23. Number of Hypoglycemia Events Lunch Time + 5 Hours [ Time Frame: The 5 hour period following lunch during the study admission ]
    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).

  24. Units of Insulin Injected Between 2 Hours Before and 5 Hours After Breakfast [ Time Frame: The 7 hour period including the two hours before and the 5 hours after breakfast ]
    Sum of all system provided insulin for breakfast (as planned) post-prandial excursion, including anticipation

  25. Units of Insulin Injected (Units/kg) Overall [ Time Frame: The 24 hour study admission from 4pm to 4pm ]
    Calculation of all system-provided insulin (units/kg) injected during the 24hr study admission.

  26. Units of Insulin Injected Between 2 Hours Before and 5 Hours After Dinner [ Time Frame: The 7 hour period including the 2 hours before and 5 hours after dinner ]
    Sum of all system provided insulin for dinner (late) post-prandial excursion, including anticipation


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04877730


Locations
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United States, Virginia
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Sue Brown, MD University of Virginia Center for Diabetes Technology
  Study Documents (Full-Text)

Documents provided by Sue Brown, University of Virginia:
Study Protocol and Statistical Analysis Plan  [PDF] November 18, 2021
Informed Consent Form  [PDF] October 22, 2021

More Information
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Responsible Party: Sue Brown, Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT04877730    
Other Study ID Numbers: 210035
UC4DK108483 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2021    Key Record Dates
Results First Posted: May 17, 2023
Last Update Posted: May 17, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Generally data will be made available after the primary publications of each study.
Access Criteria: Data Sharing agreements will be formulated by the study team.

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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
Keywords provided by Sue Brown, University of Virginia:
Type 1 Diabetes (T1D)
Continuous Glucose Monitor (CGM)
Insulin Pump
Fully Automated Closed Loop (FCL)
Hybrid Closed Loop (HCL)
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases