Trial Outcomes & Findings for Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients (NCT NCT03353792)

Last Updated: 2022-11-18

Results Overview

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 through the CL/AP system. In addition, there is no specific cut off value used for Glutamine C4 enrichment, rather a change or reduction was expected and noted."

Recruitment status

TERMINATED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

Baseline to 8 - 10 weeks

Results posted on

2022-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	CL/AP System To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients. CL/AP system: CL/AP system enabled insulin pump/CGM combination	Usual Care Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording. usual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording
Overall Study STARTED	4	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CL/AP System To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients. CL/AP system: CL/AP system enabled insulin pump/CGM combination	Usual Care Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording. usual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording
Overall Study Lost to Follow-up	1	0
Overall Study Participant Unable to Manage Device	1	0

Baseline Characteristics

Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline to 8 - 10 weeks

Population: Only 2 participants (per protocol complete cases) in the intervention had data that was analyzable due to technical issues that occured with the usual care group.

Outcome measures

Outcome measures
Measure	CL/AP System n=2 Participants To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients. CL/AP system: CL/AP system enabled insulin pump/CGM combination	Usual Care Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording. usual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording
Brain Alternate Fuel Uptake Baseline	10.855 percent enrichment of Gln4 Standard Deviation 10.642	—
Brain Alternate Fuel Uptake Follow Up	7.28 percent enrichment of Gln4 Standard Deviation 8.888	—
Brain Alternate Fuel Uptake Change	3.57 percent enrichment of Gln4 Standard Deviation 1.754	—

SECONDARY outcome

Timeframe: Baseline to 8-10 weeks

Population: Only those that completed both assessments (did not drop out) were included in the analyses.

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

Outcome measures

Outcome measures
Measure	CL/AP System n=2 Participants To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients. CL/AP system: CL/AP system enabled insulin pump/CGM combination	Usual Care n=3 Participants Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording. usual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording
Change in Cognitive Function: MOCA Baseline	23 units on a scale Standard Deviation 0	27 units on a scale Standard Deviation 2
Change in Cognitive Function: MOCA Follow Up	25.5 units on a scale Standard Deviation 0.707	29 units on a scale Standard Deviation 0
Change in Cognitive Function: MOCA Change	-2.5 units on a scale Standard Deviation 0.707	-2 units on a scale Standard Deviation 2

SECONDARY outcome

Timeframe: Baseline to 8-10 weeks

Population: Only those that completed both assessments (did not drop out) were included in the analyses.

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.

Outcome measures

Outcome measures
Measure	CL/AP System n=2 Participants To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients. CL/AP system: CL/AP system enabled insulin pump/CGM combination	Usual Care n=3 Participants Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording. usual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording
Change in Cognitive Function: Trail Test A Baseline	63 seconds Standard Deviation 39	28 seconds Standard Deviation 11
Change in Cognitive Function: Trail Test A Follow Up	34 seconds Standard Deviation 3	21 seconds Standard Deviation 5
Change in Cognitive Function: Trail Test A Change	29 seconds Standard Deviation 42	7 seconds Standard Deviation 16

SECONDARY outcome

Timeframe: Baseline to 8-10 weeks

Population: Only those that completed both assessments (did not drop out) were included in the analyses.

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.

Outcome measures

Outcome measures
Measure	CL/AP System n=2 Participants To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients. CL/AP system: CL/AP system enabled insulin pump/CGM combination	Usual Care n=3 Participants Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording. usual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording
Change in Cognitive Function: Trail Test B Baseline	86 seconds Standard Deviation 22	54 seconds Standard Deviation 13
Change in Cognitive Function: Trail Test B Follow Up	68 seconds Standard Deviation 23	42 seconds Standard Deviation 7
Change in Cognitive Function: Trail Test B Change	18 seconds Standard Deviation 1	12 seconds Standard Deviation 17

SECONDARY outcome

Timeframe: Baseline to 8-10 weeks

Population: Only those that completed both assessments (did not drop out) were included in the analyses.

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.

Outcome measures

Outcome measures
Measure	CL/AP System n=2 Participants To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients. CL/AP system: CL/AP system enabled insulin pump/CGM combination	Usual Care n=3 Participants Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording. usual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording
Change in Cognitive Function: Grooved Pegboard Test Baseline	105 seconds Standard Deviation 64	78 seconds Standard Deviation 13
Change in Cognitive Function: Grooved Pegboard Test Follow Up	100 seconds Standard Deviation 53	73 seconds Standard Deviation 18
Change in Cognitive Function: Grooved Pegboard Test Change	5 seconds Standard Deviation 11	5 seconds Standard Deviation 8

Adverse Events

CL/AP System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raimund Herzog, MD, MHS

Associate Professor of Medicine

Phone: (877) 925-3637

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	CL/AP System n=4 Participants To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients. CL/AP system: CL/AP system enabled insulin pump/CGM combination	Usual Care n=3 Participants Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording. usual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording	Total n=7 Participants Total of all reporting groups
Age, Customized Age Categorized · 50-59 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Customized Age Categorized · 60-69 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Customized Age Categorized · 70-79 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants