Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients
NCT ID: NCT03353792
Last Updated: 2022-11-18
Study Results
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View full resultsBasic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2017-11-01
2019-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
Interventions
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CL/AP system
CL/AP system enabled insulin pump/CGM combination
usual diabetic care
usual diabetic care (insulin pump therapy) along with CGM recording
Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
75 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Raimund Herzog, MD
Role: PRINCIPAL_INVESTIGATOR
Yale School of Medicine Department of Endocrinology
Locations
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Yale New Haven Hospital
New Haven, Connecticut, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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