Status:
TERMINATED
Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type1 Diabetes Mellitus
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
To demonstrate that a new insulin pump system can prevent low glucose episodes and improve brain function in aged Type 1 diabetes mellitus subjects.
Detailed Description
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2019
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03353792
Start Date
November 1 2017
End Date
August 28 2019
Last Update
November 18 2022
Active Locations (1)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510