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

Type 1 Diabetes Mellitus Clinical Trial

— DCLP3  

Official title:

A Pivotal Study of t:Slim X2 With Control-IQ Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03563313
• Other study ID #: DCLP3
• Secondary ID: UC4DK108483
• Status: Completed
• Phase: N/A
• Start date: June 28, 2018
• Est. completion date: April 8, 2019

Study information

• Verified date: April 2020
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: April 8, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• t:slim X2 with Control-IQ Technology & Dexcom G6 CGM
Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home.
• Sensor-augmented pump (SAP)
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.

Locations

Country	Name	City	State
United States	Barbara Davis Center, University of Colorado	Aurora	Colorado
United States	Harvard University (Joslin Diabetes Center)	Boston	Massachusetts
United States	University of Virginia Center for Diabetes Technology	Charlottesville	Virginia
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Sansum Diabetes Research Institute	Santa Barbara	California
United States	Stanford University	Stanford	California

Sponsors (6)

Lead Sponsor	Collaborator
University of Virginia	DexCom, Inc., Jaeb Center for Health Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Roche Diagnostics, Tandem Diabetes Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Severe Hypoglycemia (Per Protocol)	Severe hypoglycemia (per protocol)	26 weeks
Other	Number of Participants With Diabetic Ketoacidosis (Per Protocol)	Diabetic ketoacidosis (per protocol)	26 weeks
Other	Ketone Events Defined as Day With Ketone Level >1.0 mmol/L	Ketone events defined as day with ketone level >1.0 mmol/L	26 weeks
Other	CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)	CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL)	26 weeks
Other	CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)	CGM-measured hyperglycemic events (>15 minutes with glucose concentration >300 mg/dL)	26 weeks
Other	BG-measured Hypoglycemic Events (One BG Record <54 mg/dL)	BG-measured hypoglycemic events (one BG record <54 mg/dL)	26 weeks
Other	BG-measured Hyperglycemic Events (One BG Record >350 mg/dL)	BG-measured hyperglycemic events (one BG record >350 mg/dL)	26 weeks
Other	Worsening of HbA1c From Baseline to 26 Weeks by >0.5%	Worsening of HbA1c from baseline to 26 weeks by >0.5%	26 weeks
Other	Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE)	Other serious adverse events (SAE) and serious adverse device events (SADE)	26 weeks
Other	Adverse Device Effects (ADE)	Adverse device effects (ADE)	26 weeks
Other	Unanticipated Adverse Device Effects (UADE)	Unanticipated adverse device effects (UADE)	26 weeks
Other	Number of Participants With SH Events	For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group	26 weeks
Other	SH Event Rate Per 100 Person-years	For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate.	26 weeks
Other	Number of Participants With DKA Events	For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated.	26 weeks
Other	DKA Event Rate Per 100 Person-years	For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate.	26 weeks
Other	Any Adverse Event Rate Per 100 Person-years	For this outcome, the adverse event rate per 100 person-years calculated as a rate.	26 weeks
Primary	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.	26 weeks
Secondary	CGM Time Above 180	CGM-measured % above 180 mg/dL	26 weeks
Secondary	CGM Mean Glucose	CGM-measured mean glucose	26 weeks
Secondary	HbA1c at 26 Weeks	Hemoglobin A1c measured at 26 weeks	26 weeks
Secondary	CGM Time Below 70	CGM-measured % below 70 mg/dL	26 weeks
Secondary	CGM Time Below 54	CGM-measured % below 54 mg/dL	26 weeks
Secondary	CGM Time in Range 70-140 mg/dL	CGM-measured % in range 70-140 mg/dL	26 weeks
Secondary	Coefficient of Variability	CGM measured glucose variability measured with the coefficient of variation (CV)	26 weeks
Secondary	Standard Deviation of CGM	CGM measured glucose variability measured with the standard deviation (SD)	26 weeks
Secondary	CGM Time Below 60	CGM-measured % below 60 mg/dL	26 weeks
Secondary	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)	26 weeks
Secondary	CGM Hypoglycemia Events	CGM-measured events of at least 15 consecutive minutes <70mg/dL per week	26 weeks
Secondary	CGM Time >250	CGM-measured % >250 mg/dL	26 weeks
Secondary	CGM Time >300	CGM-measured % >300 mg/dL	26 weeks
Secondary	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)	26 weeks
Secondary	Number of Participants With HbA1c <7.0% at 26 Weeks	Number of participants HbA1c <7.0% at 26 weeks	26 weeks
Secondary	Number of Participants With HbA1c <7.5% at 26 Weeks	Number of Participants with HbA1c <7.5% at 26 weeks	26 weeks
Secondary	Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >0.5%	HbA1c improvement from baseline to 26 weeks >0.5%	26 weeks
Secondary	Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0%	HbA1c improvement from baseline to 26 weeks >1.0%	26 weeks
Secondary	HbA1c Relative Improvement From Baseline to 26 Weeks >10%	HbA1c relative improvement from baseline to 26 weeks >10%	26 weeks
Secondary	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	26 weeks
Secondary	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.	26 weeks
Secondary	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.	26 weeks
Secondary	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.	26 weeks
Secondary	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.	26 weeks
Secondary	Clarke Hypoglycemia Awareness Scores	Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)	26 weeks
Secondary	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.	26 weeks
Secondary	System Usability Scores (SUS)	System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability	26 weeks
Secondary	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.	26 weeks
Secondary	Total Daily Insulin	Total Daily Insulin (units)	26 weeks
Secondary	Basal:Bolus Insulin Ratio	Basal:Bolus Insulin Ratio	26 weeks
Secondary	Weight	Weight (kg)	26 weeks
Secondary	BMI	Body Mass Index (BMI) kg/m^2	26 weeks