NCT01825382

Brief Summary

The goal of this prospective pilot study is to evaluate the use of remote technology (iBGStar in combination with Diabetes Manager App on iPhone) to patient related outcomes, and a hypoglycemia fear questionnaire. In the future, this study might lead to investigating the role of social media with mobile phones in Type 1 Diabetes (T1D) care. Moreover, the number of patients with T1D continues to increase, and such technology could conceivably help compensate for the shortages of endocrinologists providing care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_4

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

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

May 21, 2014

Status Verified

May 1, 2014

Enrollment Period

8 months

First QC Date

January 29, 2013

Last Update Submit

May 19, 2014

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Patient Reported Outcomes as it relates to hypoglycemia fear and quality of life.

    Primary outcome is patient related outcomes and changes based on the hypoglycemia fear questionnaire and changes in patient comfort in meter use.

    6 months

Secondary Outcomes (1)

  • Improvement in glucose control and indices off glucose variability from SMBG and CGM data.

    6 months

Study Arms (2)

Accu-chek Meter

NO INTERVENTION

Patients receiving the Accu-chek nano meter for use during the study.

iBGStar meter interventional Arm

EXPERIMENTAL

Subjects are given iBGstar meter along with iPhone to use as interventional meter.

Device: iBGStar meter

Interventions

iBGStar meterDEVICE

Subjects will receive iBGStar meter and iPhone to use as meter during the study.

iBGStar meter interventional Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects that meet the following criteria will be considered for admission to the study:
  • Signed informed consent before any study-related activities
  • Male or female aged 18 years and older T1D duration \>1 year
  • A1c \<10%
  • Willingness to routinely practice at least 3-7 blood glucose measurements per day
  • Ability and willingness to adhere to the protocol including scheduled study visits and blinded CGM wear intermittently) for 6 months. During the weeks of blinded CGM wear, subjects will not be able to use their own real-time CGMs (if they own it)
  • Able to speak, read and write English

You may not qualify if:

  • Subjects will be excluded from the study if any of the following apply:
  • Pregnant or intention to become pregnant during the course of the study
  • Severe unexplained hypoglycemia requiring emergency treatment in the previous 6 months
  • Use of systemic or inhaled corticosteroids
  • History of hemoglobinopathies
  • Diagnosis of anemia
  • History of pancreatitis
  • Extensive skin changes/diseases that inhibit wearing a sensor on normal skin
  • Known allergy to adhesives
  • Current participation in another investigational study protocol. Must have completed a previous study at least 30 days prior to enrollment.
  • Any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent
  • Subjects will not be allowed to use real-time CGM during the blinded CGM wear week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Garg SK, Shah VN, Akturk HK, Beatson C, Snell-Bergeon JK. Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar(R) in Type 1 Diabetes Management. Diabetes Ther. 2017 Aug;8(4):811-819. doi: 10.1007/s13300-017-0272-5. Epub 2017 May 29.

    PMID: 28555339DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Satish K Garg, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Pediatrics, Editor in Chief DT&T

Study Record Dates

First Submitted

January 29, 2013

First Posted

April 5, 2013

Study Start

December 1, 2012

Primary Completion

August 1, 2013

Study Completion

November 1, 2013

Last Updated

May 21, 2014

Record last verified: 2014-05

Locations

US(1)