Sleep and Glycemic Control in Type 2 Diabetes Adolescents (NCT04213547) | Clinical Trial Compass
RecruitingNot Applicable
Sleep and Glycemic Control in Type 2 Diabetes Adolescents
United States90 participantsStarted 2020-09-16
Plain-language summary
The primary objective is to determine the cross-sectional relationship between sleep duration (as measured by 14 days of actigraphy) and glycemic control in an adolescent Type 2 Diabetes (T2DM) cohort (age 12-20y, n=67). A secondary objective is to determine if a loss-framed incentive for achieving sleep goals can increase sleep duration in 15 adolescent patients diagnosed with T2DM with insufficient sleep. Another secondary objective is to test if increasing sleep duration leads to improved glycemic control in 15 adolescents with T2DM identified in Aim 1 as having \<8 hr sleep/evening. A focus group will be conducted prior to this intervention with patients ineligible for the intervention in order to determine appropriate text messaging.
Who can participate
Age range
12 Years – 20 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
. Subjects age 12-20
. Diagnosed with T2DM by standard laboratory criteria without pancreatic autoimmunity
. Low probability of obstructive sleep apnea (OSA) assessed via validated sleep survey
. Subjects will be included if they are taking T2DM treatments (i.e., diet modification, Metformin and/or insulin)
. Parental/guardian permission and child assent
. Completed Aim 1 evaluation
. Average sleep duration \< 8 hours per night as determined by actigraphy in Aim 1
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.
. HbA1c ≤ 10% as HbA1c \>10 correlates to poor adherence
Exclusion criteria
. Non-English speaking subject (as questionnaires used are validated in English)
. Institutionalized patients as sleep duration will not be of their own accord, and therefore is not generalizable to the rest of the adolescent T2DM population.
. Patients with other forms of Diabetes Mellitus (e.g. Type 1 Diabetes)
. Behavioral disorders that may affect data collection (e.g. autism spectrum disorder) will be determined on a case-by-case basis. These include patients that are unable to answer questionnaires on their own, participate in a sleep diary, wear devices and/or understand incentives.
. Oral or IV steroid treatment within the past month
. Females with known pregnancies as these patients will not be generalizable to the rest of the adolescent T2DM population and pregnancy may alter sleep duration.
. Subjects with known hyperthyroidism, pain syndrome, or serious medical condition that can affect sleep.
. Subjects with hemoglobinopathies that affect hemoglobin A1c measurement.