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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK101984-01A1 | U.S. NIH Grant/Contract | View source | |
| 1DP3DK112227-01 | U.S. NIH Grant/Contract | View source |
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Initial difficulty with recruitment was exasperated by COVID pause of the study and then the end of funding.
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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To demonstrate that a new insulin pump system can prevent low glucose episodes and improve brain function in aged Type 1 diabetes mellitus subjects.
The goals of this proposal are to implement a Close-Loop/Artificial Pancreas (CL/AP) system in older patients with type 1 diabetes mellitus (T1DM) in order to reverse brain metabolic adaptations and restore metabolic sensitivity, hypoglycemia awareness and appropriate hormonal counterregulatory responses (CRR). For purposes of this study we are looking to enroll aged T1DM subjects under insulin pump treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CL/AP system | Active Comparator | 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. |
|
| usual care | Placebo Comparator | Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CL/AP system | Device | CL/AP system enabled insulin pump/CGM combination |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Alternate Fuel Uptake | 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." | Baseline to 8 - 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Function: MOCA | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raimund Herzog, MD | Yale School of Medicine Department of Endocrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants that were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brain Alternate Fuel Uptake | 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." | 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. | Posted | Mean | Standard Deviation | percent enrichment of Gln4 | Baseline to 8 - 10 weeks |
|
Up to 10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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This study experienced low enrollment prior to being paused due to COVID19. Upon restart of the study, it was determined that there were not sufficient funds to fully resume the trial. The overall enrollment did not provide adequate numbers to perform statistical analyses outside of providing summary statistics on those that were enrolled and those that completed the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raimund Herzog, MD, MHS | Associate Professor of Medicine | (877) 925-3637 | raimund.herzog@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2022 | Sep 30, 2022 | Prot_SAP_000.pdf |
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The design is a single-site, parallel group, randomized clinical trail. Following enrollement and CGM documentation of hypoglycemia during the 4-week run-in period, study participants are randomized to intervention and control groups.
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The intervention consists of treatment with a CL/AP-enabled insulin pump/CGM combination; subjects in the control group will continue their usual diabetes care (insulin pump therapy) along with CGM recording .
| usual diabetic care |
| Device |
usual diabetic care (insulin pump therapy) along with CGM recording |
|
| Baseline to 8-10 weeks |
| Change in Cognitive Function: Trail Test A | 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 to 8-10 weeks |
| Change in Cognitive Function: Trail Test B | 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 to 8-10 weeks |
| Change in Cognitive Function: Grooved Pegboard Test | 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 to 8-10 weeks |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| 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 |
| OG001 | 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 |
|
|
| Secondary | Change in Cognitive Function: MOCA | 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 | Only those that completed both assessments (did not drop out) were included in the analyses. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 8-10 weeks |
|
|
|
| Secondary | Change in Cognitive Function: Trail Test A | 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. | Only those that completed both assessments (did not drop out) were included in the analyses. | Posted | Mean | Standard Deviation | seconds | Baseline to 8-10 weeks |
|
|
|
| Secondary | Change in Cognitive Function: Trail Test B | 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. | Only those that completed both assessments (did not drop out) were included in the analyses. | Posted | Mean | Standard Deviation | seconds | Baseline to 8-10 weeks |
|
|
|
| Secondary | Change in Cognitive Function: Grooved Pegboard Test | 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. | Only those that completed both assessments (did not drop out) were included in the analyses. | Posted | Mean | Standard Deviation | seconds | Baseline to 8-10 weeks |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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 | 0 | 3 | 0 | 3 | 0 | 3 |
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| Change |
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| Change |
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| Change |
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| Change |
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