Clinical trial NCT03353792: Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients
Official title: Restoring Brain Metabolism and Function in Older Adult T1DM Patients Using an AP System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type1 Diabetes Mellitus
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-11-27
Enrollment: 7
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design is a single-site, parallel group, randomized clinical trail. Following enrollement and CGM documentation of hypoglycemia during the 4-week run-in period, study participants are randomized to intervention and control groups.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Brain Alternate Fuel Uptake
timeFrame: Baseline to 8 - 10 weeks
Secondary outcomes:
measure: Change in Cognitive Function: MOCA
timeFrame: Baseline to 8-10 weeks
measure: Change in Cognitive Function: Trail Test A
timeFrame: Baseline to 8-10 weeks
measure: Change in Cognitive Function: Trail Test B
timeFrame: Baseline to 8-10 weeks
measure: Change in Cognitive Function: Grooved Pegboard Test
timeFrame: Baseline to 8-10 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale School of Medicine Department of Endocrinology
name: Raimund Herzog, MD
role: PRINCIPAL_INVESTIGATOR
References: