Biobehavioral Mechanisms of Glucose Variability (NCT01835964) | Clinical Trial Compass
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 range
21 Years – 65 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change Between Pre and Post Challenge Glucose Variability