Trial Outcomes & Findings for Glycemic Control and the Brain in Children With Type 1 Diabetes (NCT NCT03428932)
NCT ID: NCT03428932
Last Updated: 2023-05-16
Results Overview
Trends in total and regional grey matter volume
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
6 months
Results posted on
2023-05-16
Participant Flow
Two enrolled participants did not meet inclusion/exclusion criteria and were screen failures before randomization. Two additional participants failed to complete all required baseline assessments or procedures. The remaining 42 subjects participated in the study and were included in all data analyses in line with the intention to treat principle. There were no additional participant losses.
Participant milestones
| Measure |
Standard Care
Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Standard Care: Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months.
|
Closed-Loop
Subjects will transition from their current treatment (insulin pump or injections) onto the Medtronic 670G insulin pump (intervention arm as a comparator) and will have close contact with the study team. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Closed Loop (Medtronic 670G): A loaner Medtronic 670G insulin pump, Enlite 3 sensor and GST3C Guardian transmitter will be utilized
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glycemic Control and the Brain in Children With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Standard Care
n=21 Participants
Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Standard Care: Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months.
|
Closed-Loop
n=21 Participants
Subjects will transition from their current treatment (insulin pump or injections) onto the Medtronic 670G insulin pump (intervention arm as a comparator) and will have close contact with the study team. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Closed Loop (Medtronic 670G): A loaner Medtronic 670G insulin pump, Enlite 3 sensor and GST3C Guardian transmitter will be utilized
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15.7 years
STANDARD_DEVIATION 0.97 • n=5 Participants
|
15.9 years
STANDARD_DEVIATION 1.76 • n=7 Participants
|
15.8 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Gray Matter Volume
|
739.16 cm^3
n=5 Participants
|
727.27 cm^3
n=7 Participants
|
734.22 cm^3
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTrends in total and regional grey matter volume
Outcome measures
| Measure |
Standard Care
n=21 Participants
Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Standard Care: Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months.
|
Closed-Loop
n=21 Participants
Subjects will transition from their current treatment (insulin pump or injections) onto the Medtronic 670G insulin pump (intervention arm as a comparator) and will have close contact with the study team. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Closed Loop (Medtronic 670G): A loaner Medtronic 670G insulin pump, Enlite 3 sensor and GST3C Guardian transmitter will be utilized
|
|---|---|---|
|
Changes in Gray Matter Volume in the Brain
|
-4.83 centimeters cubed
Interval -8.92 to -0.74
|
-9.31 centimeters cubed
Interval -14.46 to -4.17
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: fMRI was not available for 3 Subjects in the Standard Care Group and for 1 in the Closed-Loop Group.
Blood Oxygen level diffusion (BOLD) Functional Magnetic Resonance Imaging (fMRI) was measured to assess functional activation occurring during "no-go" relative to "go" trials during a Go/No-Go cognitive task. Parameter estimates for an individual subject are obtained by modeling the subject's BOLD time series at each voxel against the expected BOLD response to a given task. Statistical weights (i.e., parameter estimates of activation strength) are determined based on how closely the observed and expected signals agree for each task condition to create parameter maps over the entire brain. Higher-level parameter estimates are generated via contrasts of the estimates from specific task conditions, which can lead to positive or negative values, depending on the relative activation of the conditions.
Outcome measures
| Measure |
Standard Care
n=18 Participants
Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Standard Care: Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months.
|
Closed-Loop
n=20 Participants
Subjects will transition from their current treatment (insulin pump or injections) onto the Medtronic 670G insulin pump (intervention arm as a comparator) and will have close contact with the study team. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Closed Loop (Medtronic 670G): A loaner Medtronic 670G insulin pump, Enlite 3 sensor and GST3C Guardian transmitter will be utilized
|
|---|---|---|
|
Changes in Brain Activation (Dorsal Anterior Cingulate, Inferior Frontal Gyrus and/or Parietal Cortex)
|
78.58 parameter estimates (betas)
Interval 35.98 to 158.81
|
-119.51 parameter estimates (betas)
Interval -297.01 to -104.65
|
SECONDARY outcome
Timeframe: 6 monthsThe Wechsler Abbreviated Scale of Intelligence second edition (WASI-II) was used. The WASI-II is composed of four subtests: Block Design, Vocabulary, Matrix Reasoning, and Similarities. The WASI-II used in this study produces a Perceptual Reasoning Index (PRI) score from the Block Design and Matrix Reasoning subtests' age-corrected scaled scores. The index scores are derived from a summation of the comprising scaled scores. The PRI score range is: 50-150. Higher scores mean better outcomes. Change over time in the PRI score is reported in each group.
Outcome measures
| Measure |
Standard Care
n=21 Participants
Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Standard Care: Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months.
|
Closed-Loop
n=21 Participants
Subjects will transition from their current treatment (insulin pump or injections) onto the Medtronic 670G insulin pump (intervention arm as a comparator) and will have close contact with the study team. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Closed Loop (Medtronic 670G): A loaner Medtronic 670G insulin pump, Enlite 3 sensor and GST3C Guardian transmitter will be utilized
|
|---|---|---|
|
Changes in WASI-II Perceptual Reasoning Index (PRI)
|
2.05 score on a scale
Interval -0.17 to 4.27
|
6.10 score on a scale
Interval 4.05 to 8.14
|
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Closed-Loop
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Care
n=21 participants at risk
Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Standard Care: Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months.
|
Closed-Loop
n=21 participants at risk
Subjects will transition from their current treatment (insulin pump or injections) onto the Medtronic 670G insulin pump (intervention arm as a comparator) and will have close contact with the study team. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Closed Loop (Medtronic 670G): A loaner Medtronic 670G insulin pump, Enlite 3 sensor and GST3C Guardian transmitter will be utilized
|
|---|---|---|
|
Endocrine disorders
Hyperglycemia, Large Ketones, DKA
|
0.00%
0/21 • 6 months
|
4.8%
1/21 • Number of events 1 • 6 months
|
|
General disorders
Acute illness: Tonsillitis
|
0.00%
0/21 • 6 months
|
4.8%
1/21 • Number of events 1 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place