NCT04436796: DCLP4

The International Diabetes Closed Loop (iDCL) Trial: Protocol 4

Completed NA Results posted Last updated 2 December 2022

What this trial tests

NA trial testing interoperable Artificial Pancreas System (iAPS) in Type 1 Diabetes in 35 participants. Completed in 10 May 2021.

Timeline

5 August 2020

Primary endpoint
10 May 2021

10 May 2021

Quick facts

Lead sponsor	Sansum Diabetes Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	5 August 2020
Primary completion	10 May 2021
Estimated completion	10 May 2021
Sites	5 locations across United States

Drugs / interventions tested

• interoperable Artificial Pancreas System (iAPS)
• Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

Sansum Diabetes Research Institute

Who can join

18 and older, any sex, with Type 1 Diabetes. 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.

Percent CGM Time in Range 70-180 mg/dL Primary · 13 weeks

This results shown is mean percent time in range 70-180 mg/dL.

Group	Value	95% CI
Artificial Pancreas	69	± 14
Sensor Augmented Pump/Predictive Low Glucose Suspend	66	± 14

Non-inferiority for CGM Time <54 mg/dL Primary · 13 weeks

Superiority for time in range 70-180 mg/dL and non-inferiority for time \<54 mg/dL measured with CGM will be considered primary endpoints, analyzed using a hierarchical gatekeeping testing procedure

Group	Value	95% CI
Artificial Pancreas	0.41	± 0.39
Sensor Augmented Pump/Predictive Low Glucose Suspend	0.71	± 0.82

CGM Mean Glucose Secondary · 13 weeks

CGM-measured mean glucose (mg/dL)

Group	Value	95% CI
Artificial Pancreas	158	± 22
Sensor Augmented Pump/Predictive Low Glucose Suspend	156	± 27

CGM Time > 180 Secondary · 13 weeks

CGM time \> 180 mg/dL

Group	Value	95% CI
Artificial Pancreas	29	± 15
Sensor Augmented Pump/Predictive Low Glucose Suspend	30	± 16

CGM Time > 250 Secondary · 13 weeks

CGM time \> 250 mg/dL

Group	Value	95% CI
Artificial Pancreas	9	± 8
Sensor Augmented Pump/Predictive Low Glucose Suspend	8	± 8

CGM Time < 70 Secondary · 13 weeks

CGM time \< 70 mg/dL

Group	Value	95% CI
Artificial Pancreas	2.1	± 1.7
Sensor Augmented Pump/Predictive Low Glucose Suspend	3.5	± 3.1

CGM Time < 54 (Superiority) Secondary · 13 weeks

CGM time \< 54 mg/dL (Superiority)

Group	Value	95% CI
Artificial Pancreas	0.41	± 0.39
Sensor Augmented Pump/Predictive Low Glucose Suspend	0.71	± 0.82

Coefficient of Variation Secondary · 13 weeks

CGM measured glucose variability measured with the coefficient of variation (CV)

Group	Value	95% CI
Artificial Pancreas	34.5	± 5.3
Sensor Augmented Pump/Predictive Low Glucose Suspend	34.9	± 5.7

CGM Time in Range 70-140 mg/dL Secondary · 13 weeks

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

Group	Value	95% CI
Artificial Pancreas	44	± 14
Sensor Augmented Pump/Predictive Low Glucose Suspend	43	± 17

Standard Deviation Secondary · 13 weeks

CGM measured glucose variability measured with the standard deviation (SD)

Group	Value	95% CI
Artificial Pancreas	34.5	± 5.3
Sensor Augmented Pump/Predictive Low Glucose Suspend	34.9	± 5.7

CGM Time < 60 Secondary · 13 weeks

CGM time \< 60 mg/dL

Group	Value	95% CI
Artificial Pancreas	0.81	± 0.73
Sensor Augmented Pump/Predictive Low Glucose Suspend	1.39	± 1.45

LBGI Secondary · 13 weeks

Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 \< LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 \< LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI \> 5.0 is associated with high risk of hypoglycemia.

Group	Value	95% CI
Artificial Pancreas	0.6	± 0.4
Sensor Augmented Pump/Predictive Low Glucose Suspend	1.0	± 0.8

Adverse events — posted to ClinicalTrials.gov

Time frame: From protocol entry through last study date which is approximately 26-28 weeks per participant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Artificial Pancreas

Serious: 0/35 (0%)

Deaths: 0/35

Sensor Augmented Pump/Predictive Low Glucose Suspend

Serious: 1/35 (3%)

Deaths: 0/35

Serious adverse events (1 terms)

Reaction	System	Artificial Pancreas	Sensor Augmented Pump/Pred…
Severe Hypoglycemia	Endocrine disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Artificial Pancreas	Sensor Augmented Pump/Pred…
Hyperglycemia or ketosis events without meeting criteria for Diabetic Ketoacidosis	Endocrine disorders	—	—
Medical Device Site Bleeding	Skin and subcutaneous tissue disorders	—	—
COVID-19	Infections and infestations	—	—

Most-reported serious reactions: Severe Hypoglycemia.

Data from ClinicalTrials.gov NCT04436796 adverse events section.

Sponsor's own description

The investigators aim to compare the efficacy and safety of an AID system using an adaptive MPC algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) in people with type 1 diabetes.

Publications & conference data

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

1. 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
2. Outpatient Randomized Crossover Comparison of Zone Model Predictive Control Automated Insulin Delivery with Weekly Data Driven Adaptation Versus Sensor-Augmented Pump: Results from the International Diabetes Closed-Loop Trial 4.
   Pinsker JE, Dassau E, Deshpande S, Raghinaru D, et al · · 2022 · cited 11× · PMID 35549708 · DOI 10.1089/dia.2022.0084
3. Glucose Rate-of-Change and Insulin-on-Board Jointly Weighted Zone Model Predictive Control.
   Deshpande S, Doyle FJ, Dassau E. · · 2023 · cited 1× · PMID 38525198 · DOI 10.1109/tcst.2023.3291573