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Restoring brain metabolism and function in older adult T1DM patients using an AP system

  • Study HIC#:2000020059
  • Last Updated:07/15/2021

This study is being done to demonstrate that a new closed loop insulin pump can prevent low glucose episodes and enhance brain function in older patients with Type 1 diabetes. 

For more information about this study, contact: (203) 737-4777  or email diabetes.research@yale.edu.

  • Age50 years - 80 years
  • GenderBoth
  • Start Date11/20/2017
  • End Date11/30/2021

Eligibility Criteria

Inclusion criteria:

  • Age 50-75 years
  • Type 1 diabetes (>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)
  • BMI <27 kg/m2
  • Good general health

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
  • Vegetarian diet
  • Any contraindications for MRI scanning, including presence of metallic implants or claustrophobia
  • Heavy exercise on a regular basis (i.e. marathon runners)
  • 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, or lactating. 

Sub-Investigators

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