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New treatment option 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 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.
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
- Aim 1 for child:
- 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)
You likely can't join if
- Aim 1 for child:
- 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. These include...
- Oral or IV steroid treatment within the past month
See the full eligibility criteria
- Aim 1 for child:
- 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)
- Parental/guardian permission and child assent Aim 1 for parent: 1\. Parent or legal guardian of child that meets for Aim 1. Aim 2 for child:
- 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
- Adherence \> 80% Focus group for child:
- people aged 12-20
- Diagnosed with type 2 diabetes without pancreatic autoimmunity
- Aim 1 for child:
- 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...
- 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
- Known diagnosis of obstructive sleep apnea or other sleep disorder Aim 1 for Parent:
- Non-English speaking subject (as questionnaires used are validated in English)
- Parent/guardians with cognitive disorders that may affect data collection (determined on a case-by-case basis) Aim 2 for child: 1\. Do not own a smart phone or tablet Focus group for child:
- 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's taking place
- 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 - 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?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.