Trial Outcomes & Findings for The International Diabetes Closed Loop (iDCL) Trial: Protocol 1 (NCT NCT02985866)
NCT ID: NCT02985866
Last Updated: 2022-12-05
Results Overview
CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
127 participants
Primary outcome timeframe
Post randomization (final 11 weeks)
Results posted on
2022-12-05
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
62
|
|
Overall Study
COMPLETED
|
64
|
61
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Poor CGM data
|
1
|
1
|
Baseline Characteristics
The International Diabetes Closed Loop (iDCL) Trial: Protocol 1
Baseline characteristics by cohort
| Measure |
Artificial Pancreas (Closed Loop Control)
n=65 Participants
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
|
Sensor Augmented Therapy
n=62 Participants
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
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<21
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Customized
21 to <35
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Customized
35 to <65
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Customized
≥65
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Diabetes duration at randomization (years)
1 to <5
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Diabetes duration at randomization (years)
5 to <10
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Diabetes duration at randomization (years)
10 to <20
|
13 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Diabetes duration at randomization (years)
20 to <30
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Diabetes duration at randomization (years)
30 to <40
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Diabetes duration at randomization (years)
≥40
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Prior CGM use
Never
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Prior CGM use
In past, but not current
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Prior CGM use
Current
|
48 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
BMI at enrollment (kg/m2)
<18
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
BMI at enrollment (kg/m2)
18 to <25
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
BMI at enrollment (kg/m2)
25 to <30
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
BMI at enrollment (kg/m2)
≥30
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
HbA1c at randomization: laboratory
<7.0% (53 mmol/ml)
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
HbA1c at randomization: laboratory
7.0% to <7.5% (53 to <58 mmol/mol)
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
HbA1c at randomization: laboratory
7.5% to <8.0% (58 to <64 mmol/mol)
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
HbA1c at randomization: laboratory
8.0% to ≤10.5% (64 to ≤91 mmol/mol)
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
C-Peptide at randomization (nmol/L): Laboratory
<0.003
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
C-Peptide at randomization (nmol/L): Laboratory
0.003 to <0.1
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
C-Peptide at randomization (nmol/L): Laboratory
0.1 to <0.5
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
C-Peptide at randomization (nmol/L): Laboratory
≥0.5
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Diabetes ketoacidosis events in the last 12 months
0
|
64 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Diabetes ketoacidosis events in the last 12 months
1
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Diabetes ketoacidosis events in the last 12 months
2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Severe hypoglycemic events in past 12 months
0
|
63 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Severe hypoglycemic events in past 12 months
1
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post randomization (final 11 weeks)CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)
Outcome measures
| Measure |
Artificial Pancreas (Closed Loop Control)
n=64 Participants
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
|
Sensor Augmented Therapy
n=61 Participants
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
|
|---|---|---|
|
Time Below 70 mg/dL
|
2.4 percentage of total CGM time
Standard Deviation 1.7
|
4.0 percentage of total CGM time
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: Post randomization (final 11 weeks)CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority)
Outcome measures
| Measure |
Artificial Pancreas (Closed Loop Control)
n=64 Participants
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
|
Sensor Augmented Therapy
n=61 Participants
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
|
|---|---|---|
|
Time Above 180 mg/dL
|
34 percentage of total CGM time
Standard Deviation 11
|
39 percentage of total CGM time
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Post randomization (final 11 weeks)Percent time CGM readings were below 54 mg/dL
Outcome measures
| Measure |
Artificial Pancreas (Closed Loop Control)
n=64 Participants
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
|
Sensor Augmented Therapy
n=61 Participants
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
|
|---|---|---|
|
Time Below 54 mg/dL
|
0.6 Percentage
Standard Deviation 0.6
|
1.1 Percentage
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Post randomization (final 11 weeks)CGM-measured % time below 60 mg/dL
Outcome measures
| Measure |
Artificial Pancreas (Closed Loop Control)
n=64 Participants
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
|
Sensor Augmented Therapy
n=61 Participants
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
|
|---|---|---|
|
Time Below 60 mg/dL
|
1.1 Percentage
Standard Deviation 1.0
|
1.9 Percentage
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Post randomization (final 11 weeks)CGM-measured % in range 70-180 mg/dL
Outcome measures
| Measure |
Artificial Pancreas (Closed Loop Control)
n=64 Participants
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
|
Sensor Augmented Therapy
n=61 Participants
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
|
|---|---|---|
|
Time in Range 70-180 mg/dL
|
64 Percentage
Standard Deviation 11
|
57 Percentage
Standard Deviation 14
|
SECONDARY outcome
Timeframe: Post randomization (final 11 weeks)CGM-measured % time in range 70-140 mg/dL
Outcome measures
| Measure |
Artificial Pancreas (Closed Loop Control)
n=64 Participants
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
|
Sensor Augmented Therapy
n=61 Participants
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
|
|---|---|---|
|
Time in Range 70-140 mg/dL
|
39 Percentage
Standard Deviation 10
|
35 Percentage
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Post randomization (final 11 weeks)CGM-measured % time above 250 mg/dL
Outcome measures
| Measure |
Artificial Pancreas (Closed Loop Control)
n=64 Participants
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
|
Sensor Augmented Therapy
n=61 Participants
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
|
|---|---|---|
|
Time Above 250 mg/dL
|
11.2 Percentage
Standard Deviation 7.4
|
13.7 Percentage
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Post randomization (final 11 weeks)CGM-measured % time above 300 mg/dL
Outcome measures
| Measure |
Artificial Pancreas (Closed Loop Control)
n=64 Participants
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
|
Sensor Augmented Therapy
n=61 Participants
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
|
|---|---|---|
|
Time Above 300 mg/dL
|
4.4 Percentage
Standard Deviation 4.2
|
5.7 Percentage
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: Post randomization (final 11 weeks)CGM-measured coefficient of variation (CV)
Outcome measures
| Measure |
Artificial Pancreas (Closed Loop Control)
n=64 Participants
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
|
Sensor Augmented Therapy
n=61 Participants
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
|
|---|---|---|
|
Coefficient of Variation
|
37 Percentage
Standard Deviation 5
|
38 Percentage
Standard Deviation 5
|
Adverse Events
Artificial Pancreas (Closed Loop Control)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Sensor Augmented Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Artificial Pancreas (Closed Loop Control)
n=65 participants at risk
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
|
Sensor Augmented Therapy
n=62 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Hypoglycemic seizure
|
1.5%
1/65 • Number of events 1 • 13 weeks
|
0.00%
0/62 • 13 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/65 • Number of events 1 • 13 weeks
|
0.00%
0/62 • 13 weeks
|
Other adverse events
| Measure |
Artificial Pancreas (Closed Loop Control)
n=65 participants at risk
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
|
Sensor Augmented Therapy
n=62 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/65 • 13 weeks
|
1.6%
1/62 • Number of events 1 • 13 weeks
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/65 • 13 weeks
|
1.6%
1/62 • Number of events 1 • 13 weeks
|
Additional Information
Boris Kovatchev, PhD
University of Virginia Center for Diabetes Technology
Phone: 434-982-0602
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place