Meal Composition and the Influence on Pre-prandial Blood Glucose Values (NCT03028506) | Clinical Trial Compass
CompletedNot Applicable
Meal Composition and the Influence on Pre-prandial Blood Glucose Values
50 participantsStarted 2015-01
Plain-language summary
The purpose of the proposed study is to assess the distribution of carbohydrates and fat in the diet of women with type 1 diabetes during pregnancy. More specifically, it will look at the distribution of carbohydrate in the diet during weeks 29-32 of pregnancy. The carbohydrate distribution and fat content of the meal will be compared to maternal glucose control, preprandial glucose levels, and the percentile for weight of the infant at birth. In addition, each meal and snack will be classified as low-moderate fat or high fat.
Who can participate
Age range
16 Years – 45 Years
Sex
FEMALE
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:
* Female, age 16-45, all ethnic groups,
* Type 1 diabetes
* Blood glucose logs at least 75% complete
* Food intake records during weeks 29-32 that are at least 75% complete
Exclusion Criteria:
* Maternal medical conditions:
* Renal disease
* Restrictive lung disease
* Cyanotic heart disease (severe heart disease where mother is blue)
* Antiphospholipid antibody syndrome
* Collagen-vascular disease (lupus)
* Substance use and abuse (drugs)
* Multiple gestation
* Genetic disorders
* Severe malnutrition
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.