Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Loss frame sleep extension intervention

    Behavioral

    Aim 2 will be an interventional study design utilizing Fitbit and text messaging to perform a loss-framed incentive intervention designed to motivate participants to increase their sleep duration. Glycemic control will be measured via laboratory testing of hemoglobin A1c and Libre continuous glucose monitoring (CGM) for 2 weeks pre- and post-intervention. A focus group will be conducted prior to this intervention with patients ineligible for the intervention in order to determine appropriate text messaging.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Sleep duration (for Aim 2)

Will assess for sleep extension throughout intervention

Time frame
13 weeks
2

Hemoglobin A1c (for Aim 1)

Aim 1 is assessing cross-sectional relationship of A1c to sleep duration

Time frame
baseline
3

BMI (for Aim 1)

Aim 1 is assessing cross-sectional relationship of BMI to sleep duration

Time frame
baseline
4

Qualitative data from focus group

Qualitative output from focus group discussion on text messages

Time frame
baseline at focus group

Secondary outcomes

1

Glycemic control

Will assess for change in hemoglobin a1c throughout intervention

Time frame
13 weeks
2

Glycemic control

Will assess for change in continuous glucose monitor measures throughout intervention

Time frame
13 weeks
3

BMI

Will assess for change in body mass index (BMI) throughout intervention

Time frame
13 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Philadelphia

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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