CompletedNot Applicable

Biobehavioral Mechanisms of Glucose Variability

United States30 participantsStarted 2013-04

Plain-language summary

The purpose of this study is to investigate how blood sugar changes in response to insulin and what the body does to counter-act low blood sugar in people with Type 1 Diabetes Mellitus. Insulin sensitivity is the term used to describe blood sugar changes within the body in response to insulin. Greater understanding of insulin sensitivity, particularly how the body responds to low blood sugar, will help us to better predict how blood sugar levels will change. All subjects will receive a liquid mixed-meal and will have their blood sugar response monitored in order to study insulin sensitivity. All subjects will receive additional insulin injections that are given to cause a low blood sugar in order to understand how the body responds to a low blood sugar. All subjects will be closely monitored during the time the insulin is given, by frequent checks of blood sugar and constant medical and nursing supervision. Details of the visits, tests and procedures are described below. During this study, the study team will ask that subjects to use their own insulin pump and own glucometer. Subjects will need to use the same glucometer for the entire study. Subjects will be provided 1 box of strips. Subjects will be required to use lispro (Humalog) insulin 2-3 days before your inpatient admission which will be provided free of charge.

Who can participate

Age range21 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinical diagnosis of type 1 diabetes mellitus for ≥2 years. For an individual to be enrolled at least one criterion from each list must be met. * Criteria for documented hyperglycemia (at least 1 must be met): * Fasting Blood Glucose (BG) ≥126 mg/dL * 2h Oral Glucose Tolerance Test (OGTT) ≥200 mg/dL * Hemoglobin (HbA1c) ≥6.5% * BG ≥200 mg/dL with symptoms * History of hyperglycemia consistent with diabetes * Criteria for requiring insulin at diagnosis (1 must be met): * required insulin at diagnosis and continually thereafter * no insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and insulin eventually required and used continually * no insulin at diagnosis but continued hyperglycemia, positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and insulin eventually required and used continually * Use of an insulin pump for at least six months prior to the study. * Using a bolus calculator with pre-defined parameters for carbohydrate ratio(s), and insulin sensitivity factor(s). * Signed informed consent. * Age ≥21 and \<65 years old. * HbA1c ≤10% as measured with DCA 2000 or equivalent device. * Willingness to use lispro (Humalog) insulin for metabolic challenge admission. * Willingness to perform self-monitoring blood glucose (SMBG) \>4 times/day. * Willingness to avoid consumption of acetaminop…

What they're measuring

Change Between Pre and Post Challenge Glucose Variability

Timeframe: 3 days

Trial details

NCT IDNCT01835964

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-01

Results submitted2019-01-23