Preschool CGM Use and Glucose Variability in Type 1 Diabetes | NCT03293082

Studies
Preschool CGM Use and Glucose Variability in Type 1 Diabetes

NCT03293082

Sponsor

University of Ljubljana, Faculty of Medicine

Status

Completed

Last Update Posted

Oct 3, 2017Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Type 1 Diabetes Mellitus

Interventions

CGM ON
CGM OFF

Countries

Slovenia

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

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2017Actual

Primary Completion Date

Sep 30, 2017Actual

Completion Date

Sep 30, 2017Actual

First Submitted Date

Sep 21, 2017

First Submission Date that Met QC Criteria

Sep 21, 2017

First Posted Date

Sep 26, 2017Actual

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

Oct 2, 2017

Last Update Posted Date

Oct 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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 objectives of this clinical study is to evaluate the efficacy continuous glucose monitoring (CGM) use on glucose variability (GV) in preschool children with T1D treated with CSII.

Downloads from CGM and CSII saved in pdf from will be retrospectively reviewed and analysed for all preschool children with type 1 diabetes in Slovenia. Glucose variability and other glycemic parameters will be analyzed separately for periods when CGM was used (CGM and SMBG data) and compared to periods when CGM was not used (SMBG only data).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CGM ON	Device	The period of time when continuous glucose monitoring was used, in edition to SMBG
CGM OFF	Device	The period of time when continuous glucose monitoring was not used, only SMBG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose variability	Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose	Three years

Secondary Outcomes

Measure	Description	Time Frame
Mean intersticial glucose	Mean glucose as measured with CGM	Three years
Mean blood glucose	Mean glucose as measured with SMBG	Three years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject with Type 1 diabetes (> 6 months since diagnosis)
Insulin infusion pump CSII therapy for at least 3 months
Age ≤ 7 years
HbA1c at inclusion ≥ 6.5 and < 10
BMI SDS - below the 95th percentile for age

Exclusion Criteria:

Concomitant diseases that influence metabolic control
Participation in any other interventional study
Known or suspected allergy to trial products

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Years

Standard Ages

Child

Study Population

Population of preschool children with type 1 diabetes aged up to 7 years that were prescribed sensor use in the observational period.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UMC - University Children's Hospital Ljubljana		Ljubljana		1000	Slovenia

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

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