NCT02813421

Brief Summary

The purpose of the study is to learn more about blood glucose control when people with Type 1 Diabetes switch to an insulin pump. The investigators hope to learn whether using a continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to stable blood glucoses and less frequent insulin pump dose changes during the transition to an insulin pump.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

May 25, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

June 2, 2016

Results QC Date

January 25, 2019

Last Update Submit

May 3, 2021

Conditions

Type 1 Diabetes Mellitus

Keywords

CGM

Outcome Measures

Primary Outcomes (1)

  • Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL)

    First 6 weeks of insulin pump therapy

Secondary Outcomes (12)

  • Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL)

    First 5 days of insulin pump therapy

  • Mean Blood Glucose (mg/dL)

    First 6 weeks of insulin pump therapy

  • Percentage Time Hyperglycemic

    First 6 weeks of insulin pump therapy

  • Total Daily Insulin Dose (Units)

    First 6 weeks of insulin pump therapy

  • Percentage Basal Insulin (%)

    First 6 weeks of insulin pump therapy

  • +7 more secondary outcomes

Study Arms (2)

CGM Informed

EXPERIMENTAL

CGM data was available for use when determining starting insulin pump doses.

Device: CGM Informed

Control

NO INTERVENTION

CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.

Interventions

CGM InformedDEVICE
Also known as: iPro2 Professional Continuous Glucose Monitor
CGM Informed

Eligibility Criteria

Age2 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Males and Females aged 2-24 years
  • Clinical diagnosis of Type 1 diabetes mellitus
  • Duration of diabetes: At least 6 months
  • \- This will ensure some glycemic stability prior to study, and most children do not start on an insulin pump until about 6 months into their diagnosis.
  • Basal/bolus insulin regimen using long-acting and rapid-acting insulin
  • \- This will provide a uniform method of insulin therapy.
  • Willingness to perform at least 6-8 capillary blood glucose tests per day while wearing the iPro®2
  • Willingness to wear the iPro®2 for 5 days continuously per insertion
  • Participant agrees to comply with the study protocol requirements
  • Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights signed by the participant and/or parent guardian

You may not qualify if:

  • Comorbid conditions, including but not limited to cystic fibrosis, oncologic processes, other systemic diseases that may affect overall glycemic control
  • Glucocorticoid use within 2 weeks of study enrollment
  • Concurrent use of other medications that may affect glycemic control
  • Prior CGM use in the past 6 months
  • The participant has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) in the area of iPro®2 placement that has not been resolved at the time of enrollment and would inhibit the participant from wearing the iPro®2.
  • Non-English or non-Spanish speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Dr. Jessica Ferris
Organization
Children's Hospital Los Angeles
jeferris@chla.usc.edu
323-361-4606

Study Officials

  • Jessica A Ferris, MD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Fellow

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 27, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 25, 2021

Results First Posted

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)