Sleep and Glycemic Control in Type 2 Diabetes Adolescents
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-20
SponsorChildren's Hospital of Philadelphia
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Loss frame sleep extension intervention
Treatment groups
90 Participants
are divided into 1 treatment groupSponsors and collaborators
Children's Hospital of Philadelphia
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov