Adults 50 to 75, 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.
Brain Alternate Fuel UptakePrimary· Baseline to 8 - 10 weeks
Change in brain alternate fuel uptake under hypoglycemia was measured by assessing the percent enrichment of Glutamine 4 (Gln4). Change was measured by subtracting follow up from baseline.
Astrocytic glutamine C4 enrichment is a measure of brain acetate metabolism (an alternate fuel to glucose). Previous studies have shown that in people who have been exposed to frequent hypoglycemic episodes, glutamine C4 enrichment increases. Therefore, we expected a reduction in Glutamine C4 percent enrichment in the follow up NMR scans in the intervention group who avoided frequent hypoglycemic episodes t
Baseline
Group
Value
95% CI
CL/AP System
10.855
± 10.642
Follow Up
Group
Value
95% CI
CL/AP System
7.28
± 8.888
Change
Group
Value
95% CI
CL/AP System
3.57
± 1.754
Change in Cognitive Function: MOCASecondary· Baseline to 8-10 weeks
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal. Change was calculated by subtracting follow up from baseline. https://www.parkinsons.va.gov/resources/MoCA-Instructions-English.pdf
Baseline
Group
Value
95% CI
CL/AP System
23
± 0
Usual Care
27
± 2
Follow Up
Group
Value
95% CI
CL/AP System
25.5
± 0.707
Usual Care
29
± 0
Change
Group
Value
95% CI
CL/AP System
-2.5
± 0.707
Usual Care
-2
± 2
Change in Cognitive Function: Trail Test ASecondary· Baseline to 8-10 weeks
Trail making test (TMT) A is a test of visual attention and task switching. It provides information about visual search speed, speed of processing and executive function. Time is measured in seconds. The typical average time to complete the test is 29 seconds, a "deficient" performance would be \>78 seconds; most people are able to complete in 90 seconds. Change was calculated by subtracting follow up from baseline.
Baseline
Group
Value
95% CI
CL/AP System
63
± 39
Usual Care
28
± 11
Follow Up
Group
Value
95% CI
CL/AP System
34
± 3
Usual Care
21
± 5
Change
Group
Value
95% CI
CL/AP System
29
± 42
Usual Care
7
± 16
Change in Cognitive Function: Trail Test BSecondary· Baseline to 8-10 weeks
Trail making test (TMT) B is a test of visual attention and task switching. It provides information about visual search speed, speed of processing and executive function. Time will be measured in seconds. The typical average time to complete the test is 75 seconds, a "deficient" performance would be \>273 seconds; most people are able to complete in 180 seconds. Change was calculated by subtracting follow up from baseline.
Baseline
Group
Value
95% CI
CL/AP System
86
± 22
Usual Care
54
± 13
Follow Up
Group
Value
95% CI
CL/AP System
68
± 23
Usual Care
42
± 7
Change
Group
Value
95% CI
CL/AP System
18
± 1
Usual Care
12
± 17
Change in Cognitive Function: Grooved Pegboard TestSecondary· Baseline to 8-10 weeks
The grooved pegboard test is a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consists of a small board of holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. The task was completed using the dominant hand. Time was measured in seconds.
Baseline
Group
Value
95% CI
CL/AP System
105
± 64
Usual Care
78
± 13
Follow Up
Group
Value
95% CI
CL/AP System
100
± 53
Usual Care
73
± 18
Change
Group
Value
95% CI
CL/AP System
5
± 11
Usual Care
5
± 8
Sponsor's own description
To demonstrate that a new insulin pump system can prevent low glucose episodes and improve brain function in aged Type 1 diabetes mellitus subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 18 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03353792.