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Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients | Clinical Trials | Clareo Health

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

Restoring Brain Metabolism and Function in Older Adult T1DM Patients Using an AP System

NCT03353792•Yale University

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

Age

50 - 75 years

Sex

ALL

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
+2 more criteria

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
+5 more criteria

Locations (1)

Yale New Haven Hospital

New Haven, Connecticut, United States

Key Dates

Start Date

November 1, 2017

Primary Completion Date

August 28, 2019

Completion Date

August 28, 2019

Last Updated

November 18, 2022

Enrollment

ACTUAL participants

Conditions

Type1 Diabetes Mellitus

Interventions

CL/AP system

DEVICE

usual diabetic care

DEVICE

Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes

NCT05777330

Type1 Diabetes Mellitus

View study

RECRUITING

China Diabetes Registry by Metabolic Management Center

NCT03811470

Type 2 Diabetes MellitusType1 Diabetes Mellitus+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes

China Diabetes Registry by Metabolic Management Center

Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus

The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes

Comparison of Real-time CGMS With Intermittently-scanned CGMS in Adolescents and Adults With Type 1 Diabetes Mellitus

The International Diabetes Closed Loop (iDCL) Trial: Protocol 1