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

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02558491

Run by

Daniel Chernavvsky, MD

People needed

33

Starts

2015-09-01

Expected to finish

2017-02-01

Last updated by the study team

2024-08-07

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Age 21- 65years old.
• 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.
• Demonstration of proper mental status and cognition for the study
• MDI subjects should be administering the Lantus (glargine), Tresiba [degludec], or Levemir [Detemir] dose at approximately the same time each day.
• CSII subjects must currently be using the bolus calculator function of the current insulin pump with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor.
• MDI users must currently be using Intensive Insulin Therapy including carbohydrate counting and use of pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor.
• Willing to use Humalog (lispro) or Novolog (aspart) insulin during the study procedures for MDI subjects.
• CSII subjects must be willing to use the current bolus calculator pump parameters and enter all carbohydrate intake into the pump during the 28 day data collection period.
• MDI users must be willing to use their carbohydrate counting parameters for all meal dosing and enter the information into the MySugr app.
• Ability to access the Internet to provide data to the clinical team or to travel to the research center so that the study equipment and personal pump can be downloaded.
• An understanding of and willingness to follow the protocol and sign the informed consent.
• Exclusion Criteria: The presence of any of the following is an exclusion for the study:
• Diabetic ketoacidosis (DKA) in the 6 months prior to enrollment.
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment.
• Current treatment of a seizure disorder.
• Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.
• Atrial or ventricular arrhythmias (benign premature atrial contractions [PACs] and premature ventricular contractions [PVCs] allowed)
• Cystic fibrosis.
• Pregnancy, breast-feeding, or intention of becoming pregnant over time of study procedures.

Where it is running

• University of Virginia Center for Diabetes Technology — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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