The Impact of Continuous Glucose Monitoring Use on Sleep... | NCT01425255

Studies
The Impact of Continuous Glucose Monitoring Use on Sleep in Parents of Children With Type 1 Diabetes Mellitus

NCT01425255

Sponsor

Wolfson Medical Center

Status

Withdrawn

Last Update Posted

Jun 21, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Type 1 Diabetes

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment finished and a paper was published.

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Aug 26, 2011

First Submission Date that Met QC Criteria

Aug 26, 2011

First Posted Date

Aug 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2016

Last Update Posted Date

Jun 21, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

zohar landau, Head of Pediatric Endocrinology Service, Wolfson Medical CenterPrincipal Investigator

Lead Sponsor

Wolfson Medical CenterOTHER_GOV

Collaborators

Name	Class
Tel Aviv Medical Center	OTHER
Sheba Medical Center	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this prospective exploratory study is to compare sleep quality and sleep-wake patterns in parents of children with type 1 diabetes (T1D) before and several weeks after initiating using real-time continuous glucose monitoring (RT-CGM) of their children.

Detailed Description

Few weeks before scheduled initiation of RT-CGM use of a child with T1D, the 'dominant parent' (the main caregiver during the nighttime in the family) will obtain an informed consent. This will be done during a routine visit in the diabetes clinic. The participants will complete a sleep quality questionnaire (PSQI) and instructions on care of the actigraph and how to keep complete the daily sleep diary will be given. The participants will be instructed to wear the actigraph for 7 consequences nights. Four to eight weeks after initiation of RT-CGM use, the 'dominant parent' will be asked to wear the actigraph for 7 consequences nights and to complete the sleep quality questionnaire and the daily sleep diary.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parents of children with Type 1 diabetes		before and several weeks after initiating using RT-CGM of their children.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sleep quality	Actigraphy: Sleep Diary:During the weeks participants will wear the actigraph, they will be asked to rate their previous nights' sleep using a very short questionnaire. Pittsburgh Sleep Quality Index (PSQI):	1 year

Secondary Outcomes

Measure	Description	Time Frame
Glycemic control	HbA1c level Mean blood glucose level: Number of severe hypoglycemic episodes and diabetic ketoacidoacidosis episodes	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parents of children up to 16 years old with type 1 diabetes

Exclusion Criteria:

Either the child or parent had obstructive sleep apnea, narcolepsy, or restless legs syndrome.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Juvenile Diabetes Clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zohar Landau, MD	Wolfson Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
E. Wolfson Medical Center		Holon		58100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided