The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas

University of Virginia168 enrolled

Overview

The objective of the study is to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial.

After consent is signed, eligibility will be assessed. Eligible participants not currently using an insulin pump and Dexcom CGM with minimum data requirements will initiate a run-in phase of 2 to 8 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) using t:slim X2 with Control-IQ Technology vs. SAP for 6 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

168

Conditions

Type 1 Diabetes Mellitus

Interventions

t:slim X2 with Control-IQ Technology & Dexcom G6 CGMDEVICE

Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.

Sensor-augmented pump (SAP)DEVICE

Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year. 2. Familiarity and use of a carbohydrate ratio for meal boluses. 3. Age ≥14.0 years old. 4. For females, not currently known to be pregnant. 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 child-bearing 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. 5. For participants \<18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency. 6. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use. 7. Willingness to use a regular insulin pump during the study with no automatic insulin adjustment based on glucose level when assigned to participate in an SAP group 8. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol. 9. 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. 10. Total daily insulin dose (TDD) at least 10 U/day. 11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial. Exclusion Criteria 1. Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas). 2. Hemophilia or any other bleeding disorder. 3. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. 4. Participation in another pharmaceutical or device trial at the time of enrollment or during the study. 5. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc. or TypeZero Technologies, LLC, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.

Locations (7)

Sansum Diabetes Research Institute

Santa Barbara, California, United States

Stanford University

Stanford, California, United States

Barbara Davis Center, University of Colorado

Aurora, Colorado, United States

Harvard University (Joslin Diabetes Center)

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Time in Target Range

The primary outcome is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SAP group.

Time frame: 26 weeks

Secondary Outcomes

CGM Time Above 180

CGM-measured % above 180 mg/dL

Time frame: 26 weeks

CGM Mean Glucose

CGM-measured mean glucose

Time frame: 26 weeks

HbA1c at 26 Weeks

Hemoglobin A1c measured at 26 weeks

Time frame: 26 weeks

CGM Time Below 70

CGM-measured % below 70 mg/dL

Time frame: 26 weeks

CGM Time Below 54

CGM-measured % below 54 mg/dL

Time frame: 26 weeks

CGM Time in Range 70-140 mg/dL

CGM-measured % in range 70-140 mg/dL

Time frame: 26 weeks

Coefficient of Variability

CGM measured glucose variability measured with the coefficient of variation (CV)

Time frame: 26 weeks

Standard Deviation of CGM

CGM measured glucose variability measured with the standard deviation (SD)

Time frame: 26 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Mayo Clinic

Rochester, Minnesota, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

CGM-measured % below 60 mg/dL

Time frame: 26 weeks

LBGI

Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values \<1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)

Time frame: 26 weeks

CGM Hypoglycemia Events

CGM-measured events of at least 15 consecutive minutes \<70mg/dL per week

Time frame: 26 weeks

CGM Time >250

CGM-measured % \>250 mg/dL

Time frame: 26 weeks

CGM Time >300

CGM-measured % \>300 mg/dL

Time frame: 26 weeks

HBGI

High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia. Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL. Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. Diabetes Technol Ther 2003;5:817-828pmid:14633347)

Time frame: 26 weeks

Number of Participants With HbA1c <7.0% at 26 Weeks

Number of participants HbA1c \<7.0% at 26 weeks

Time frame: 26 weeks

Number of Participants With HbA1c <7.5% at 26 Weeks

Number of Participants with HbA1c \<7.5% at 26 weeks

Time frame: 26 weeks

Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >0.5%

HbA1c improvement from baseline to 26 weeks \>0.5%

Time frame: 26 weeks

Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0%

HbA1c improvement from baseline to 26 weeks \>1.0%

Time frame: 26 weeks

HbA1c Relative Improvement From Baseline to 26 Weeks >10%

HbA1c relative improvement from baseline to 26 weeks \>10%

Time frame: 26 weeks

Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0% or HbA1c <7.0% at 26 Weeks

HbA1c improvement from baseline to 26 weeks \>1.0% or HbA1c \<7.0% at 26 weeks

Time frame: 26 weeks

HFS-II

For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses. Fear of Hypoglycemia Survey (HFS-II) for adults has a total score that is summed from the two subscale scores (33 items) and ranges from 0 to 132 with higher scores indicating greater degrees of fear of hypoglycemia. The teen survey has a total of 25 items and the range of Total scores is 0 to 100. The parent version of the survey has a total of 26 items with Total scores that range from 0 to 108.

Time frame: 26 weeks

Hyperglycemia Avoidance Scale

Hyperglycemia Avoidance Scale total score is the sum of 21 items rated on a 4 point Likert scale from 0 (never) to 4 (almost always) and ranges from 0 to 84 with a higher score indicating greater degrees of avoiding hyperglycemia.

Time frame: 26 weeks

Diabetes Distress Scale

Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress.

Time frame: 26 weeks

Hypoglycemia Confidence Scale

Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.

Time frame: 26 weeks

Clarke Hypoglycemia Awareness Scores

Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)

Time frame: 26 weeks

INSPIRE Survey Scores

The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items.

Time frame: 26 weeks

System Usability Scores (SUS)

System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability

Time frame: 26 weeks

Technology Acceptance Questionnaire

Technology Acceptance Survey measures the user's perceptions regarding the burdens and the barriers associated with a technology with a higher score indicates increased technology acceptance. There total score uses 37 items with items are rated on a 5 point scale ranging from 1 (strongly disagree) to 5 (strongly agree) for total score range of 37-185.

Time frame: 26 weeks

Total Daily Insulin

Total Daily Insulin (units)

Time frame: 26 weeks

Basal:Bolus Insulin Ratio

Time frame: 26 weeks

Weight

Weight (kg)

Time frame: 26 weeks

BMI

Body Mass Index (BMI) kg/m\^2

Time frame: 26 weeks