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

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT03353792
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
10
Enrollment
1
Location
2
Arms
50
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CL/AP system
  • Device: usual diabetic care
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
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.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
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. brain alternate fuel uptake [8 - 10 weeks]

    change in brain alternate fuel uptake under hypoglycemia

Secondary Outcome Measures

  1. change of cognitive function [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Yale New Haven Hospital New Haven Connecticut United States 06510

Sponsors and Collaborators

  • Yale University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Raimund Herzog, MD, Yale School of Medicine Department of Endocrinology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT03353792
Other Study ID Numbers:
  • 2000020059
  • 1R01DK101984-01A1
  • 1DP3DK112227-01
First Posted:
Nov 27, 2017
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Jul 12, 2022