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

Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial: A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor-Augmented Pump Therapy in the Management of Type 1 Diabetes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02985866

Acronym

iDCL

Enrollment

127

Registered

2016-12-07

Start date

2017-10-27

Completion date

2018-09-04

Last updated

2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type1 Diabetes Mellitus

Keywords

Artificial Pancreas, Closed Loop Control, Continuous Glucose Monitor (CGM), inControl Diabetes Management Platform

Brief summary

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.

Detailed description

The protocol is a 3-month parallel group multi-center randomized trial designed to compare Control-to-Range (CTR) closed-loop (CL) with sensor augmented pump therapy (SAP). Approximately 126 subjects will be entered into the randomized trial at approximately seven clinical sites in the United States, such that at least 110 subjects complete the randomized trial. A maximum of 200 subjects may be enrolled in the study in order to achieve the goal of randomizing 126 subjects. In order to have a broad range of glycemic control among the subjects, a study goal will be to have a minimum of 50 subjects with HbA1c ≥ 7.5% and 50 with HbA1c \< 7.5%.

Interventions

DEVICEArtificial Pancreas

Use of CTR at home for 3 months

OTHERSensor Augmented Therapy

Use of personal pump with study CGM & glucometer at home for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

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. Use of an insulin pump for at least 6 months 3. Age ≥14 years old 4. HbA1c level \<10.5% at screening 5. For females, not currently known to be pregnant 6. Willingness not to add glucose-lowering agents (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) during the study 7. Willingness, if not assigned to the closed-loop group, to avoid use of any closed-loop control system for the duration of the clinical trial 8. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the unblinded study CGM is in use 9. Willingness to establish network connectivity on at least a weekly basis either via local Wifi network or via a study-provided cellular service 10. Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra) 11. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol 12. For subjects less than 18 years old, living with one or more parent/legal guardian (referred to subsequently as diabetes care partner) committed to participating in study training for emergency procedures for severe hypoglycemia and able to contact the subject in case of an emergency

Exclusion criteria

1. Medical need for chronic acetaminophen 2. Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) in the 3 months prior to enrollment 3. Hemophilia or any other bleeding disorder 4. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk including any contraindication to the use of any of the study devices per FDA labeling 5. Participation in another pharmaceutical or device trial at the time of enrollment or during the study 6. Use of a closed-loop system within the last month prior to enrollment 7. Employed by, or having immediate family members employed by TypeZero Technologies, LLC

Design outcomes

Primary

Measure	Time frame	Description
Time Below 70 mg/dL	Post randomization (final 11 weeks)	CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)
Time Above 180 mg/dL	Post randomization (final 11 weeks)	CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority)

Secondary

Measure	Time frame	Description
Time in Range 70-180 mg/dL	Post randomization (final 11 weeks)	CGM-measured % in range 70-180 mg/dL
Time in Range 70-140 mg/dL	Post randomization (final 11 weeks)	CGM-measured % time in range 70-140 mg/dL
Time Below 60 mg/dL	Post randomization (final 11 weeks)	CGM-measured % time below 60 mg/dL
Time Above 300 mg/dL	Post randomization (final 11 weeks)	CGM-measured % time above 300 mg/dL
Coefficient of Variation	Post randomization (final 11 weeks)	CGM-measured coefficient of variation (CV)
Time Above 250 mg/dL	Post randomization (final 11 weeks)	CGM-measured % time above 250 mg/dL
Time Below 54 mg/dL	Post randomization (final 11 weeks)	Percent time CGM readings were below 54 mg/dL

Countries

United States

Participant flow

Recruitment details

This parallel-group, multicenter, randomized unblinded clinical trial was conducted at 7 US university centers. Participants were diagnosed with type 1 diabetes, treated with insulin for at least 1 year, using pump therapy for at least 6 months, age 14 and above, & HbA1c \<10.5% (91 mmol/mol). A study goal was to have at least 50 participants with HbA1c\<7.5% (58 mmol/mol) and at least 50 participants with HbA1c \>7.5% (58 mmol/mol). Participants were screened October 2017 - May 2018.

Pre-assignment details

Participants who used a personal Dexcom G4 or G5 CGM pre-study for at least 21 of the prior 28 days proceeded directly to randomization. For these participants, the data downloaded from the personal CGM provided the 2-week baseline data. All others wore a blinded study CGM for 2 weeks to collect baseline data, followed by 2 weeks of training using an unblinded study CGM. Successful completion of the run-in was followed by randomization.

Participants by arm

Arm	Count
Artificial Pancreas (Closed Loop Control) Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes. Artificial Pancreas: Use of CTR at home for 3 months	65
Sensor Augmented Therapy Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Sensor Augmented Therapy: Use of personal pump with study CGM & glucometer at home for 3 months	62
Total	127

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Poor CGM data	1	1

Baseline characteristics

Characteristic	Sensor Augmented Therapy	Artificial Pancreas (Closed Loop Control)	Total
Age, Customized <21	17 Participants	18 Participants	35 Participants
Age, Customized 21 to <35	21 Participants	19 Participants	40 Participants
Age, Customized 35 to <65	21 Participants	25 Participants	46 Participants
Age, Customized ≥65	3 Participants	3 Participants	6 Participants
BMI at enrollment (kg/m2) <18	0 Participants	2 Participants	2 Participants
BMI at enrollment (kg/m2) 18 to <25	29 Participants	22 Participants	51 Participants
BMI at enrollment (kg/m2) 25 to <30	22 Participants	23 Participants	45 Participants
BMI at enrollment (kg/m2) ≥30	11 Participants	18 Participants	29 Participants
C-Peptide at randomization (nmol/L): Laboratory <0.003	45 Participants	48 Participants	93 Participants
C-Peptide at randomization (nmol/L): Laboratory 0.003 to <0.1	13 Participants	9 Participants	22 Participants
C-Peptide at randomization (nmol/L): Laboratory 0.1 to <0.5	4 Participants	6 Participants	10 Participants
C-Peptide at randomization (nmol/L): Laboratory ≥0.5	0 Participants	2 Participants	2 Participants
Diabetes duration at randomization (years) 10 to <20	29 Participants	13 Participants	42 Participants
Diabetes duration at randomization (years) 1 to <5	3 Participants	10 Participants	13 Participants
Diabetes duration at randomization (years) 20 to <30	13 Participants	18 Participants	31 Participants
Diabetes duration at randomization (years) 30 to <40	9 Participants	6 Participants	15 Participants
Diabetes duration at randomization (years) ≥40	3 Participants	8 Participants	11 Participants
Diabetes duration at randomization (years) 5 to <10	5 Participants	10 Participants	15 Participants
Diabetes ketoacidosis events in the last 12 months 0	61 Participants	64 Participants	125 Participants
Diabetes ketoacidosis events in the last 12 months 1	0 Participants	1 Participants	1 Participants
Diabetes ketoacidosis events in the last 12 months 2	1 Participants	0 Participants	1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	6 Participants	9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants	59 Participants	118 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
HbA1c at randomization: laboratory <7.0% (53 mmol/ml)	21 Participants	22 Participants	43 Participants
HbA1c at randomization: laboratory 7.0% to <7.5% (53 to <58 mmol/mol)	12 Participants	11 Participants	23 Participants
HbA1c at randomization: laboratory 7.5% to <8.0% (58 to <64 mmol/mol)	15 Participants	13 Participants	28 Participants
HbA1c at randomization: laboratory 8.0% to ≤10.5% (64 to ≤91 mmol/mol)	14 Participants	19 Participants	33 Participants
Prior CGM use Current	44 Participants	48 Participants	92 Participants
Prior CGM use In past, but not current	14 Participants	16 Participants	30 Participants
Prior CGM use Never	4 Participants	1 Participants	5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	3 Participants	5 Participants
Race (NIH/OMB) Black or African American	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) More than one race	4 Participants	3 Participants	7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	3 Participants	3 Participants
Race (NIH/OMB) White	55 Participants	55 Participants	110 Participants
Severe hypoglycemic events in past 12 months 0	58 Participants	63 Participants	121 Participants
Severe hypoglycemic events in past 12 months 1	4 Participants	2 Participants	6 Participants
Sex: Female, Male Female	28 Participants	32 Participants	60 Participants
Sex: Female, Male Male	34 Participants	33 Participants	67 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 65	0 / 62
other Total, other adverse events	0 / 65	2 / 62
serious Total, serious adverse events	1 / 65	0 / 62