Clinical trial for Type 2 Diabetes
Official title Sleep and Glycemic Control in Type 2 Diabetes Adolescents
ClinicalTrials.gov ID: NCT04213547
What this study is testing
- What it's testing
- The study aims to see if sleep length affects blood sugar control in teens with Type 2 diabetes. It also tests if a specific text message incentive can help teens sleep more.
- Who it's for
- The study is looking for teenagers aged 12 to 20 who have Type 2 diabetes.
- What's involved
- Participants will wear a wrist device for 14 days to track their sleep. Some may also receive text messages to encourage them to meet sleep goals.
- Time commitment
- The study involves a 14-day sleep tracking period and participation in a focus group or intervention.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 20
You may be able to join if
- people 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
- people will be included if they are taking T2DM treatments (i.e., diet modification, Metformin and/or insulin)
- Completed Aim 1 evaluation
You likely can't join if
- 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...
- 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.
- 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...
See the full eligibility criteria
- people 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
- people will be included if they are taking T2DM treatments (i.e., diet modification, Metformin and/or insulin)
- Completed Aim 1 evaluation
- Average sleep duration \< 8 hours per night as determined by actigraphy in Aim 1
- HbA1c ≤ 10% as HbA1c \>10 correlates to poor adherence
- people aged 12-20
- Diagnosed with type 2 diabetes without pancreatic autoimmunity
- 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.
- 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.
- people with known hyperthyroidism, pain syndrome, or serious medical condition that can affect sleep.
- people with hemoglobinopathies that affect hemoglobin A1c measurement.
- Unable to obtain point-of-care hemoglobin A1c in clinic on date of recruitment
- Non-English speaking subject (as questionnaires used are validated in English)
- Non-English speaking subject (as focus group will be conducted in English)
- Lack of access to a computer, tablet or smartphone that can accommodate participation in video conferencing
The study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 20 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.