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Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM | Clinical Trials | Clareo Health

COMPLETEDNA

Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM

NCT02558491•Daniel Chernavvsky, MD

View on ClinicalTrials.gov

Summary

The purpose of this study is to demonstrate the safety and feasibility of a decision support system aimed at reducing glucose variability in T1DM patient using an insulin pump.

Detailed Description

The overall aim of this proposed research is to demonstrate the safety and feasibility of a decision support system aimed at reducing glucose variability in T1DM patient using an insulin pump. The system will be deployed on our portable medical application platform (DiAs) and will include insulin pump treatment parameters optimization and an exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment. A second phase of the trial will enroll additional users of insulin pumps, and subjects who treat their T1DM with the use of multiple daily injections (MDI) of insulin. MDI users should be administering the Lantus (glargine) dose at approximately the same time each day and use only one basal rate per day. MDI users will also use MySugr app to count carbohydrates for all meals that require insulin treatment.

Eligibility

Age

21 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Clinical diagnosis based on investigator assessment, of type 1 diabetes for at least one year and either using insulin pump therapy for at least 6 months or MDI therapy (consisting of a of Lantus \[glargine\], Tresiba \[degludec\], or Levemir \[Detemir\] plus rapid-acting meal insulin) for at least 6 months; 1-2 basal insulin injections per day, consistent in timing and amount.
•A. Historical criteria for documented hyperglycemia (at least 1 must be met):
•i. Fasting glucose ≥126 mg/dL. ii. Two-hour oral glucose tolerance test (OGTT) glucose ≥200 mg/dL. iii. Hemoglobin A1c ≥6.5% documented. iv. Random glucose ≥200 mg/dL with symptoms. v. No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes.
•B. Historical criteria for requiring insulin at diagnosis (1 must be met):
•i. Participant required insulin at diagnosis and continually thereafter. ii. Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually.
•iii. Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and did require insulin eventually and used continually.
•2. Age 21- 65years old.
•3. Females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while participating in the study. A negative urine/blood pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.
•4. Demonstration of proper mental status and cognition for the study
•5. MDI subjects should be administering the Lantus (glargine), Tresiba \[degludec\], or Levemir \[Detemir\] dose at approximately the same time each day.
+7 more criteria

Exclusion Criteria

•1. Diabetic ketoacidosis (DKA) in the 6 months prior to enrollment.
•2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment.
•3. Current treatment of a seizure disorder.
•4. Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.
•5. Atrial or ventricular arrhythmias (benign premature atrial contractions \[PACs\] and premature ventricular contractions \[PVCs\] allowed)
•6. Cystic fibrosis.
•7. Pregnancy, breast-feeding, or intention of becoming pregnant over time of study procedures.
•8. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
•i. Inpatient psychiatric treatment in the past 6 months ii. Presence of a known adrenal disorder iii. Abnormal liver function test results (Transaminase \>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function iv. Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty v. Active gastroparesis vi. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study vii. Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise viii. Abuse of alcohol or recreational drugs ix. Infectious process not anticipated to be resolved prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, deep tissue infection).
•x. Uncontrolled arterial hypertension (Resting diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>180 mmHg).
+10 more criteria

Locations (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Key Dates

Start Date

September 1, 2015

Primary Completion Date

February 1, 2017

Completion Date

February 1, 2017

Last Updated

August 7, 2024

Enrollment

ACTUAL participants

Conditions

Type 1 Diabetes Mellitus

Interventions

Decision Support System

DEVICE

Usual Care

OTHER

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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: August 7, 2024Data 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.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM

Inclusion Criteria

Exclusion Criteria

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