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The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)
NA trial testing t:slim X2 with Control-IQ Technology & Dexcom G6 CGM in Type 1 Diabetes Mellitus in 164 participants. Completed in 9 March 2020.
| Lead sponsor | University of Virginia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 164 |
| Start date | 17 January 2019 |
| Primary completion | 28 February 2020 |
| Estimated completion | 9 March 2020 |
| Sites | 7 locations across United States |
University of Virginia
14 and older, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary exploratory outcome is time in target range 70-180 mg/dL measured by CGM comparing the randomized groups CLC vs PLGS. Results from SAP to CLC group is also included here without the primary intention of comparing to CLC vs PLGS groups.
| Group | Value | 95% CI |
|---|---|---|
| Closed Loop Control (CLC) | 67.6 | ± 12.6 |
| Predictive-Low Glucose Suspend (PLGS) | 60.4 | ± 17.1 |
| SAP to CLC Group | 69 | ± 11 |
CGM-measured % above 180 mg/dL
| Group | Value | 95% CI |
|---|---|---|
| Closed Loop Control (CLC) | 31 | ± 13 |
| Predictive-Low Glucose Suspend (PLGS) | 38 | ± 18 |
| SAP to CLC Group | 29 | ± 11 |
CGM-measured mean glucose
| Group | Value | 95% CI |
|---|---|---|
| Closed Loop Control (CLC) | 160 | ± 20 |
| Predictive-Low Glucose Suspend (PLGS) | 170 | ± 30 |
| SAP to CLC Group | 158 | ± 17 |
CGM-measured % below 70 mg/dL
| Group | Value | 95% CI |
|---|---|---|
| Closed Loop Control (CLC) | 0.53 | ± 0.34 |
| Predictive-Low Glucose Suspend (PLGS) | 0.59 | ± 0.37 |
| SAP to CLC Group | 1.76 | ± 1.07 |
CGM-measured % below 54 mg/dL
| Group | Value | 95% CI |
|---|---|---|
| Closed Loop Control (CLC) | 0.2 | 0.07 – 0.48 |
| Predictive-Low Glucose Suspend (PLGS) | 0.22 | 0.06 – 0.46 |
| SAP to CLC Group | 0.19 | 0.08 – 0.36 |
CGM-measured % in range 70-140 mg/dL
| Group | Value | 95% CI |
|---|---|---|
| Closed Loop Control (CLC) | 42 | ± 12.5 |
| Predictive-Low Glucose Suspend (PLGS) | 37.1 | ± 14.2 |
| SAP to CLC Group | 45 | ± 10 |
CGM measured glucose variability measured with the coefficient of variation (CV)
| Group | Value | 95% CI |
|---|---|---|
| Closed Loop Control (CLC) | 34 | ± 4 |
| Predictive-Low Glucose Suspend (PLGS) | 35 | ± 5 |
| SAP to CLC Group | 35 | ± 5 |
CGM measured glucose variability measured with the standard deviation (SD)
| Group | Value | 95% CI |
|---|---|---|
| Closed Loop Control (CLC) | 55 | ± 12 |
| Predictive-Low Glucose Suspend (PLGS) | 60 | ± 15 |
| SAP to CLC Group | 56 | ± 12 |
CGM-measured % below 60 mg/dL
| Group | Value | 95% CI |
|---|---|---|
| Closed Loop Control (CLC) | 0.43 | 0.19 – 0.97 |
| Predictive-Low Glucose Suspend (PLGS) | 0.46 | 0.17 – 0.96 |
| SAP to CLC Group | 0.51 | 0.30 – 0.78 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Closed Loop Control (CLC) | 0.53 | ± 0.34 |
| Predictive-Low Glucose Suspend (PLGS) | 0.59 | ± 0.37 |
| SAP to CLC Group | 0.54 | ± 0.24 |
CGM-measured events of at least 15 consecutive minutes \<70 mg/dL
| Group | Value | 95% CI |
|---|---|---|
| Closed Loop Control (CLC) | 3.0 | 1.5 – 4.9 |
| Predictive-Low Glucose Suspend (PLGS) | 3.1 | 1.6 – 5.3 |
| SAP to CLC Group | 3.8 | 2.5 – 4.8 |
CGM-measured % \>250 mg/dL
| Group | Value | 95% CI |
|---|---|---|
| Closed Loop Control (CLC) | 7 | ± 6.5 |
| Predictive-Low Glucose Suspend (PLGS) | 13.6 | ± 12.4 |
| SAP to CLC Group | 7.8 | ± 6.6 |
Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Closed Loop Control (CLC) | Predictive-Low Glucose Sus… | SAP to CLC Group |
|---|---|---|---|---|
| Hyperglycemia or ketosis events without meeting criteria for Diabetic Ketoacidosis | Endocrine disorders | — | — | — |
Data from ClinicalTrials.gov NCT03591354 adverse events section.
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.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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