Clinical trial NCT03591354: The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)
Official title: An Extension Study of t:Slim X2 With Control-IQ Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Artificial Pancreas (AP)
Type 1 Diabetes Mellitus
Insulin Pump
Continuous Glucose Monitor (CGM)
Closed Loop Control (CLC)
Sensor-Augmented Pump (SAP)
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Jaeb Center for Health Research
name: Tandem Diabetes Care, Inc.
name: DexCom, Inc.
name: Roche Diagnostics GmbH
First posted: 2018-07-19
Enrollment: 164
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial of 3 months at home closed loop system vs. predictive-low glucose suspend.
Primary purpose: OTHER

Brief summary: This is a 3-month extension study (DCLP3 Extension) following a primary trial (DCLP3 or NCT03563313) to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial. Upon completion of the NIH 3-month extension study, subjects will be invited to participate in a continued use phase with Control-IQ Technology, funded by Tandem Diabetes Care, until the equipment has received FDA approval for commercial use.

Detailed description: Participants in the 6 month primary trial (DCLP3) will be invited to continue in this 3-month extension study (DCLP3 Extension) following completion of the primary trial. The closed-loop control (CLC) Intervention Group participants from the primary trial will be randomly assigned to continue CLC or to switch to Predictive Low-Glucose Suspend (PLGS) therapy with t:slim X2 with Basal-IQ and Dexcom G6 for 3 months. The Sensor-Augmented Pump (SAP) Control Group participants from the primary trial will be assigned to CLC using t:slim X2 with Control-IQ Technology and Dexcom G6 (CGM) for 3 months. Upon completion of the extension study, subjects will be invited to participate in continued use of the Control-IQ Technology until the equipment has received FDA approval for commercial use.

This extension phase has two separate objectives:

Objective 1: Among participants who used CLC in the primary trial: the primary efficacy outcome for the randomized controlled trial (RCT) is time in target range 70-180 mg/dL measured by CGM in CLC group vs. PLGS group over 3 months. Safety outcomes also will be assessed Objective 2: Among participants who used SAP in the primary trial: the primary outcome is to obtain additional safety data. Efficacy also will be assessed as a pre-post within participant analysis

Note: Primary Trial (DCLP3) is NCT03563313

Eligibility criteria: Inclusion Criteria:

1. Successful completion of the original 6-month RCT within the prior 14 days
2. 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 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.
3. 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.
4. Willingness to not use a personal CGM for the duration of the study
5. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
6. Willingness to use only lispro (Humalog) or aspart (Novolog), and to use no other insulin during the study.
7. 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., Dexcom, 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

Primary outcomes:
measure: Time in Target Range
timeFrame: 13 weeks
Secondary outcomes:
measure: CGM Time Above 180
timeFrame: 13 weeks
measure: CGM Mean Glucose
timeFrame: 13 weeks
measure: CGM Time Below 70
timeFrame: 13 weeks
measure: CGM Time Below 54
timeFrame: 13 weeks
measure: CGM Time in Range 70-140 mg/dL
timeFrame: 13 weeks
measure: Coefficient of Variation
timeFrame: 13 weeks
measure: Standard Deviation
timeFrame: 13 weeks
measure: CGM Time Below 60
timeFrame: 13 weeks
measure: LBGI
timeFrame: 13 weeks
measure: CGM Hypoglycemia Events
timeFrame: 13 weeks
measure: CGM Time >250
timeFrame: 13 weeks
measure: CGM Time >300
timeFrame: 13 weeks
measure: HBGI
timeFrame: 13 weeks
measure: HbA1c at 13 Weeks
timeFrame: 13 weeks
measure: HbA1c <7.0% at 13 Weeks
timeFrame: 13 weeks
measure: HbA1c <7.5% at 13 Weeks
timeFrame: 13 weeks
measure: HbA1c Change From Baseline to 13 Weeks >0.5%
timeFrame: 13 weeks
measure: HbA1c Change From Baseline to 13 Weeks >1.0%
timeFrame: 13 weeks
measure: HbA1c Relative Change From Baseline to 13 Weeks >10%
timeFrame: 13 weeks
measure: HbA1c Change From Baseline to 13 Weeks >1.0% or HbA1C <7.0% at 13 Weeks
timeFrame: 13 weeks
measure: HFS-II Adult
timeFrame: 13 weeks
measure: HFS-II Teen
timeFrame: 13 weeks
measure: HFS-II Parents
timeFrame: 13 weeks
measure: Hyperglycemia Avoidance Scale
timeFrame: 13 weeks
measure: Diabetes Distress Scale
timeFrame: 13 weeks
measure: Hypoglycemia Confidence Scale
timeFrame: 13 weeks
measure: Clarke Hypoglycemia Awareness Scores
timeFrame: 13 weeks
measure: INSPIRE Survey Scores- Adults
timeFrame: 13 weeks
measure: INSPIRE Survey Scores- Teens
timeFrame: 13 weeks
measure: INSPIRE Survey Scores- Parents
timeFrame: 13 weeks
measure: System Usability Scores (SUS)
timeFrame: 13 weeks
measure: Technology Acceptance Questionnaire
timeFrame: 13 weeks
measure: Total Daily Insulin
timeFrame: 13 weeks
measure: Basal:Bolus Insulin Ratio
timeFrame: 13 weeks
measure: Weight
timeFrame: 13 weeks
measure: BMI
timeFrame: 13 weeks
Other outcomes:
measure: Ketone Events Defined as Day With Ketone Level >1.0 mmol/L
timeFrame: 13 weeks
measure: CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)
timeFrame: 13 weeks
measure: CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)
timeFrame: 13 weeks
measure: Worsening of HbA1c From Randomization to 13 Weeks by >0.5%
timeFrame: 13 weeks
measure: Serious Adverse Events With a Possible or Greater Relationship to a Study Device (Including Anticipated and Unanticipated Adverse Device Effects)
timeFrame: 13 weeks
measure: Adverse Device Effects (ADE) That do Not Meet Criteria for SAE
timeFrame: 13 weeks
measure: Other Serious Adverse Events Not Related to a Study Device
timeFrame: 13 weeks
measure: Severe Hypoglycemic Events
timeFrame: 13 weeks
measure: Severe Hypoglycemic Event Rate Per 100 Person-years
timeFrame: 13 weeks
measure: Diabetic Ketoacidosis (DKA) Events
timeFrame: 13 weeks
measure: Diabetic Ketoacidosis (DKA) Event Rate Per 100 Person-years
timeFrame: 13 weeks
measure: Any Adverse Event Rate Per 100 Person-years
timeFrame: 13 weeks
measure: Time in Target Range From Months 4-12
timeFrame: Months 4-12
measure: CGM Time Above 180 From Months 4-12
timeFrame: Months 4-12
measure: CGM Mean Glucose From Months 4-12
timeFrame: Months 4-12
measure: CGM Time Below 70 From Months 4-12
timeFrame: Months 4-12
measure: CGM Time Below 54 From Months 4-12
timeFrame: Months 4-12
measure: CGM Time in Range 70-140 mg/dL From Months 4-12
timeFrame: Months 4-12
measure: Coefficient of Variation From Months 4-12
timeFrame: Months 4-12
measure: Standard Deviation From Months 4-12
timeFrame: Months 4-12
measure: CGM Time Below 60 From Months 4-12
timeFrame: Months 4-12
measure: LBGI From Months 4-12
timeFrame: Months 4-12
measure: HBGI From Months 4-12
timeFrame: Months 4-12
measure: CGM Hypoglycemia Events From Months 4-12
timeFrame: Months 4-12
measure: CGM Time >250 From Months 4-12
timeFrame: Months 4-12
measure: CGM Time >300 From Months 4-12
timeFrame: Months 4-12
measure: HbA1c at Month 6
timeFrame: Month 6 of study
measure: HbA1c at Month 9
timeFrame: Month 9 of study
measure: HbA1c at Month 12
timeFrame: Month 12 of study
measure: Ketone Events Defined as Days With Ketone Level >1.0 mmol/L From Months 4-12
timeFrame: Months 4-12
measure: CGM-measured Hypoglycemia Events (>15 Minutes With Glucose Concentration <54mg/dL) From Months 4-12
timeFrame: Months 4-12
measure: CGM-measured Hyperglycemic Events From Months 4-12
timeFrame: Months 4-12
measure: Number of Severe Hypoglycemic Events From Months 4-12
timeFrame: Months 4-12
measure: Number of Diabetic Ketoacidosis (DKA) Events From Months 4-12
timeFrame: Months 4-12
measure: Other Serious Adverse Events Not Related to a Study Device From Months 4-12
timeFrame: Months 4-12
measure: Any Adverse Event Rate Per 100 Person-years From Months 4-12
timeFrame: Months 4-12
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Barbara Davis Center, University of Colorado
state: Colorado
city: Boston
country: United States
facility: Harvard University (Joslin Diabetes Center)
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Charlottesville
country: United States
facility: University of Virginia Center for Diabetes Technology
state: Virginia
Study officials:
affiliation: University of Virginia
name: Sue Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levy CJ, O'Malley G, Raghinaru D, Kudva YC, Laffel LM, Pinsker JE, Lum JW, Brown SA; iDCL Trial Research Group. Insulin Delivery and Glucose Variability Throughout the Menstrual Cycle on Closed Loop Control for Women with Type 1 Diabetes. Diabetes Technol Ther. 2022 May;24(5):357-361. doi: 10.1089/dia.2021.0431. Epub 2022 Feb 21.