NCT02985866: iDCL

The International Diabetes Closed Loop (iDCL) Trial: Protocol 1

Completed NA Results posted Last updated 5 December 2022

What this trial tests

NA trial testing Artificial Pancreas in Type1 Diabetes Mellitus in 127 participants. Completed in 4 September 2018.

Timeline

27 October 2017

Primary endpoint
4 September 2018

4 September 2018

Quick facts

Lead sponsor	University of Virginia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	127
Start date	27 October 2017
Primary completion	4 September 2018
Estimated completion	4 September 2018
Sites	7 locations across United States

Drugs / interventions tested

• Artificial Pancreas
• Sensor Augmented Therapy

Conditions studied

• Type1 Diabetes Mellitus — all drugs for Type1 Diabetes Mellitus →

Sponsor

University of Virginia

Who can join

14 and older, any sex, with Type1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time Below 70 mg/dL Primary · Post randomization (final 11 weeks)

CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)

Group	Value	95% CI
Artificial Pancreas (Closed Loop Control)	2.4	± 1.7
Sensor Augmented Therapy	4.0	± 3.4

Time Above 180 mg/dL Primary · Post randomization (final 11 weeks)

CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority)

Group	Value	95% CI
Artificial Pancreas (Closed Loop Control)	34	± 11
Sensor Augmented Therapy	39	± 15

Time Below 54 mg/dL Secondary · Post randomization (final 11 weeks)

Percent time CGM readings were below 54 mg/dL

Group	Value	95% CI
Artificial Pancreas	0.6	± 0.6
Sensor Augmented Therapy	1.1	± 1.2

Time Below 60 mg/dL Secondary · Post randomization (final 11 weeks)

CGM-measured % time below 60 mg/dL

Group	Value	95% CI
Artificial Pancreas (Closed Loop Control)	1.1	± 1.0
Sensor Augmented Therapy	1.9	± 1.9

Time in Range 70-180 mg/dL Secondary · Post randomization (final 11 weeks)

CGM-measured % in range 70-180 mg/dL

Group	Value	95% CI
Artificial Pancreas (Closed Loop Control)	64	± 11
Sensor Augmented Therapy	57	± 14

Time in Range 70-140 mg/dL Secondary · Post randomization (final 11 weeks)

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

Group	Value	95% CI
Artificial Pancreas (Closed Loop Control)	39	± 10
Sensor Augmented Therapy	35	± 12

Time Above 250 mg/dL Secondary · Post randomization (final 11 weeks)

CGM-measured % time above 250 mg/dL

Group	Value	95% CI
Artificial Pancreas (Closed Loop Control)	11.2	± 7.4
Sensor Augmented Therapy	13.7	± 11.4

Time Above 300 mg/dL Secondary · Post randomization (final 11 weeks)

CGM-measured % time above 300 mg/dL

Group	Value	95% CI
Artificial Pancreas (Closed Loop Control)	4.4	± 4.2
Sensor Augmented Therapy	5.7	± 7.1

Coefficient of Variation Secondary · Post randomization (final 11 weeks)

CGM-measured coefficient of variation (CV)

Group	Value	95% CI
Artificial Pancreas (Closed Loop Control)	37	± 5
Sensor Augmented Therapy	38	± 5

Adverse events — posted to ClinicalTrials.gov

Time frame: 13 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Artificial Pancreas (Closed Loop Control)

Serious: 1/65 (2%)

Deaths: 0/65

Sensor Augmented Therapy

Serious: 0/62 (0%)

Deaths: 0/62

Serious adverse events (2 terms)

Reaction	System	Artificial Pancreas (Close…	Sensor Augmented Therapy
Hypoglycemic seizure	Nervous system disorders	—	—
Dehydration	Metabolism and nutrition disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Artificial Pancreas (Close…	Sensor Augmented Therapy
Gastroenteritis	Gastrointestinal disorders	—	—
Surgery	Surgical and medical procedures	—	—

Most-reported serious reactions: Hypoglycemic seizure, Dehydration.

Data from ClinicalTrials.gov NCT02985866 adverse events section.

Sponsor's own description

The objective of the study is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. First Look at Control-IQ: A New-Generation Automated Insulin Delivery System.
   Brown S, Raghinaru D, Emory E, Kovatchev B. · · 2018 · cited 54× · PMID 30305346 · DOI 10.2337/dc18-1249
2. Glucose control and psychosocial outcomes with use of automated insulin delivery for 12 to 96 weeks in type 1 diabetes: a meta-analysis of randomised controlled trials.
   Godoi A, Reis Marques I, Padrão EMH, Mahesh A, et al · · 2023 · cited 50× · PMID 37759290 · DOI 10.1186/s13098-023-01144-4
3. Better TIR, HbA1c, and less hypoglycemia in closed-loop insulin system in patients with type 1 diabetes: a meta-analysis.
   Jiao X, Shen Y, Chen Y. · · 2022 · cited 45× · PMID 35450868 · DOI 10.1136/bmjdrc-2021-002633
4. Randomized Controlled Trial of Mobile Closed-Loop Control.
   Kovatchev B, Anderson SM, Raghinaru D, Kudva YC, et al · · 2020 · cited 43× · PMID 31937608 · DOI 10.2337/dc19-1310
5. Evening and overnight closed-loop control versus 24/7 continuous closed-loop control for type 1 diabetes: a randomised crossover trial.
   Kovatchev BP, Kollar L, Anderson SM, Barnett C, et al · · 2020 · cited 35× · PMID 32864597 · DOI 10.1016/s2589-7500(19)30218-3
6. Closing the Loop on Managing Youth With Type 1 Diabetes: Children Are Not Just Small Adults.
   Sherr JL. · · 2018 · cited 19× · PMID 29936422 · DOI 10.2337/dci18-0003
7. Novel Detection and Progression Markers for Diabetes Based on Continuous Glucose Monitoring Data Dynamics.
   Montaser E, Farhy LS, Kovatchev BP. · · 2024 · cited 18× · PMID 38820084 · DOI 10.1210/clinem/dgae379
8. 2019 Diabetes Technology Meeting Abstracts
   · 2020