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

This study is currently recruiting participants.
Verified November 2017 by Yale University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03353792
First Posted: November 27, 2017
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yale University
  Purpose
To demonstrate that a new insulin pump system can prevent low glucose episodes and improve brain function in aged Type 1 diabetes mellitus subjects.

Condition Intervention
Type1 Diabetes Mellitus Device: CL/AP system Device: usual diabetic care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
Masking Description:
The intervention consists of treatment with a CL/AP-enabled insulin pump/CGM combination; subjects in the control group will continue their usual diabetes care (insulin pump therapy) along with CGM recording .
Primary Purpose: Treatment
Official Title: Restoring Brain Metabolism and Function in Older Adult T1DM Patients Using an AP System

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • brain alternate fuel uptake [ Time Frame: 8 - 10 weeks ]
    change in brain alternate fuel uptake under hypoglycemia


Secondary Outcome Measures:
  • change of cognitive function [ Time Frame: 8-10 weeks ]
    The Cantab battery of short-term memory tests will be used to compare numerical test scores before and after the study intervention to determine the effect of improved glycemia control on cognition.


Estimated Enrollment: 30
Actual Study Start Date: November 1, 2017
Estimated Study Completion Date: November 2022
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Device: CL/AP system
CL/AP system enabled insulin pump/CGM combination
Placebo Comparator: usual care
Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.
Device: usual diabetic care
usual diabetic care (insulin pump therapy) along with CGM recording

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353792


Contacts
Contact: Diabetes Research@Yale 203-737-4777 diabetes.research@yale.edu

Locations
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Raimund Herzog, MD Yale School of Medicine Department of Endocrinology
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03353792     History of Changes
Other Study ID Numbers: 2000020059
First Submitted: November 9, 2017
First Posted: November 27, 2017
Last Update Posted: December 6, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs