- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03353792
Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients (T1DM AP)
Restoring Brain Metabolism and Function in Older Adult T1DM Patients Using an AP System
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale New Haven Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Provide signed and dated informed consent form
- Male or female
- Age 50-75 years (at least 50% over the age of 65)
- T1DM (>20 years duration)
- C-peptide undetectable
- HbA1c of < 8%
- Insulin pump therapy
- History of frequent hypoglycemia with unawareness (defined as 2 or more episodes of severe hypoglycemia within one year requiring assistance) and 2 or more glucose values < 54 mg/dL during the week of Continuous Glucose Monitoring (CGM) (iPRO monitor, Medtronic) prior to enrollment
- BMI <27 kg/m2
- Good general health as evidenced by medical history and blood screening
- Willing to comply with all study procedures and be available for the duration of the study
- Willing to fast for a limited time period on the morning of a clamp study
Exclusion Criteria:
- Significant diabetic complications (untreated proliferative retinopathy, creatinine ≥1.5 mg/dl, urinary albumin levels 300 mg/day, autonomic neuropathy, painful peripheral neuropathy)
- Significant alcohol intake and vegetarian diet since both are known to have an impact on counterregulation and brain metabolism
- Any contraindications for MRI scanning, including presence of metallic implants or claustrophobia.
- Heavy exercise on a regular basis (i.e. marathon runners)
- Known allergic reactions to components of the study product(s)
- Treatment with another investigational drug or other intervention
- Active infection including hepatitis C, hepatitis B, HIV
- Any past or current history of alcohol or substance abuse
- Psychiatric or neurological disorders under active treatment
- Baseline hemoglobin < 10.5 g/dL in females, or < 12.5 g/dL in males. Blood donation within 30 days of the study
- History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
- Co-existing cardiac, liver, and kidney disease
- Abnormal liver function tests
- Women that are on oral contraceptives, post-menopausal, pregnant (as assessed by pregnancy test that will be performed on female participants at reproductive age), or lactating.
- Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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CL/AP system enabled insulin pump/CGM combination
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Placebo Comparator: usual care
Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.
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usual diabetic care (insulin pump therapy) along with CGM recording
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain Alternate Fuel Uptake
Time Frame: 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 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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cognitive Function: MOCA
Time Frame: 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
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Baseline to 8-10 weeks
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Change in Cognitive Function: Trail Test A
Time Frame: 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.
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Baseline to 8-10 weeks
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Change in Cognitive Function: Trail Test B
Time Frame: Baseline to 8-10 weeks
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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.
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Baseline to 8-10 weeks
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Change in Cognitive Function: Grooved Pegboard Test
Time Frame: Baseline to 8-10 weeks
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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.
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Baseline to 8-10 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Raimund Herzog, MD, Yale School of Medicine Department of Endocrinology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000020059
- 1R01DK101984-01A1 (U.S. NIH Grant/Contract)
- 1DP3DK112227-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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