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Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients (T1DM AP)

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Yale University

Status

Terminated

Conditions

Type1 Diabetes Mellitus

Treatments

Device: usual diabetic care
Device: CL/AP system

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03353792
2000020059
1R01DK101984-01A1 (U.S. NIH Grant/Contract)
1DP3DK112227-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

To demonstrate that a new insulin pump system can prevent low glucose episodes and improve brain function in aged Type 1 diabetes mellitus subjects.

Full 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 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.

Enrollment

7 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

7 participants in 2 patient groups, including a placebo group

CL/AP system
Active Comparator group
Description:
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.
Treatment:
Device: CL/AP system
usual care
Placebo Comparator group
Description:
Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.
Treatment:
Device: usual diabetic care

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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