N/A
Completed N=164
The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)
Source: ClinicalTrials.gov NCT03591354 ↗Enrolled (actual)
164
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Time in Target Range — 67.6; 60.4; 69 percentage of time in range — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time in Target Range |
67.6; 60.4; 69 | <0.001 sig |
| SECONDARY CGM Time Above 180 |
31; 38; 29 | — |
| SECONDARY CGM Mean Glucose |
160; 170; 158 | — |
| SECONDARY CGM Time Below 70 |
0.53; 0.59; 1.76 | — |
| SECONDARY CGM Time Below 54 |
0.2; 0.22; 0.19 | — |
| SECONDARY CGM Time in Range 70-140 mg/dL |
42; 37.1; 45 | — |
| SECONDARY Coefficient of Variation |
34; 35; 35 | — |
| SECONDARY Standard Deviation |
55; 60; 56 | — |
| SECONDARY CGM Time Below 60 |
0.43; 0.46; 0.51 | — |
| SECONDARY LBGI |
0.53; 0.59; 0.54 | — |
| SECONDARY CGM Hypoglycemia Events |
3.0; 3.1; 3.8 | — |
| SECONDARY CGM Time >250 |
7; 13.6; 7.8 | — |
| SECONDARY CGM Time >300 |
2.3; 5.2; 2.7 | — |
| SECONDARY HBGI |
6.4; 9.2; 6.6 | — |
| SECONDARY HbA1c at 13 Weeks |
7.18; 7.53; 7.09 | — |
| SECONDARY HbA1c <7.0% at 13 Weeks |
23; 15; 26 | — |
| SECONDARY HbA1c <7.5% at 13 Weeks |
35; 32; 39 | — |
| SECONDARY HbA1c Change From Baseline to 13 Weeks >0.5% |
1; 2; 14 | — |
| SECONDARY HbA1c Change From Baseline to 13 Weeks >1.0% |
0; 0; 5 | — |
| SECONDARY HbA1c Relative Change From Baseline to 13 Weeks >10% |
0; 0; 8 | — |
| SECONDARY HbA1c Change From Baseline to 13 Weeks >1.0% or HbA1C <7.0% at 13 Weeks |
23; 15; 30 | — |
| SECONDARY HFS-II Adult |
29; 35; 33 | — |
| SECONDARY HFS-II Teen |
35; 30; 30 | — |
| SECONDARY HFS-II Parents |
35; 40; 37 | — |
| SECONDARY Hyperglycemia Avoidance Scale |
37; 37; 36 | — |
| SECONDARY Diabetes Distress Scale |
1.8; 1.7; 1.7 | — |
| SECONDARY Hypoglycemia Confidence Scale |
2.0; 2.1; 1.9 | — |
| SECONDARY Clarke Hypoglycemia Awareness Scores |
1; 1; 1 | — |
| SECONDARY INSPIRE Survey Scores- Adults |
87; 87; 84 | — |
| SECONDARY INSPIRE Survey Scores- Teens |
80; 89; 77 | — |
| SECONDARY INSPIRE Survey Scores- Parents |
86; 87; 86 | — |
| SECONDARY System Usability Scores (SUS) |
85; 86.6; 85.2 | — |
| SECONDARY Technology Acceptance Questionnaire |
151; 149; 145 | — |
| SECONDARY Total Daily Insulin |
0.59; 0.68; 0.62; 0.62; 0.67; 0.64 | — |
| SECONDARY Basal:Bolus Insulin Ratio |
0.9; 0.8; 0.88; 1.0; 0.9; 0.96 | — |
| SECONDARY Weight |
77.2; 73.0; 74; 79.2; 72.8; 75 | — |
| SECONDARY BMI |
25.7; 25.1; 26; 25.6; 25.1; 26 | — |
Eligibility Criteria
Inclusion Criteria
- Successful completion of the original 6-month RCT within the prior 14 days
- 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.
- 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.
- Willingness to not use a personal CGM for the duration of the study
- Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
- Willingness to use only lispro (Humalog) or aspart (Novolog), and to use no other insulin during the study.
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
Exclusion Criteria
- Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- 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
Data sourced from ClinicalTrials.gov (NCT03591354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.