Ignite Creation Date:
2024-05-06 @ 2:07 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04213547
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2019-12-26
Brief Title:
Sleep and Glycemic Control in Type 2 Diabetes Adolescents
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Sleep Duration and Glycemic Control in Adolescents With Type 2 Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 n67 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 sleepevening A focus group will be conducted prior to this intervention with patients ineligible for the intervention in order to determine appropriate text messaging
Detailed Description:
Aim 1 will be a cross-sectional study design utilizing actigraphy watch devices to estimate sleep duration Participants will be recruited either before or after a routine outpatient clinic visit and asked to complete intake questionnaires They will then be provided an actigraphy watch device which will be worn for 14 days to estimate sleep duration and Libre continuous glucose monitor CGM to estimate glycemic control After their visit clinical data will be extracted from the electronic medical record
Aim 2 will be an interventional study design utilizing Fitbit 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
Aim 2 will be an interventional study design utilizing Fitbit 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2T32DK063688-16 | NIH | None | httpsreporternihgovquickSearch2T32DK063688-16 |