NCT03020069

Brief Summary

The purpose of this study is to determine that continuous glucose monitoring systems (CGMS) with intensive real time feedback about diabetes management from medical staff to the patient will affect motivation and/or behavior, in adolescents with poorly controlled type 1 diabetes. The investigators hypothesize that short-term CGMS use with feedback (and/or lack thereof) and patients' sense of self-efficacy will influence their stage of change and potentially glucose levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2018

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 16, 2020

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

2.7 years

First QC Date

January 11, 2017

Results QC Date

February 6, 2020

Last Update Submit

March 12, 2020

Conditions

Type 1 Diabetes

Keywords

Type 1 DiabetesAdolescentsGlucose Monitoring

Outcome Measures

Primary Outcomes (4)

  • Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months

    The PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months.

    Baseline, 3 Months

  • Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months

    HbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change.

    Baseline, 3 Months

  • Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months

    Blood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline.

    Baseline, 3 Months

  • Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months

    There are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score.

    Baseline, 3 months

Study Arms (2)

Glucose Meter

EXPERIMENTAL

Continuing Glucose Monitoring Device

Device: CGMS Device

No Glucose Meter

ACTIVE COMPARATOR

Average Blood glucose measure

Other: No Device

Interventions

CGMS DeviceDEVICE
Also known as: Continuing Glucose Monitoring Device
Glucose Meter
No DeviceOTHER
No Glucose Meter

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • type 1 diabetes
  • HbA1c \> = 8 %
  • naive to CGMS use

You may not qualify if:

  • Patients with developmental delay
  • Patients who do not use a glucose meter to test capillary blood glucose level
  • Patients without access to a telephone will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Medical Center

New York, New York, 10016, 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
Jeniece Ilkowitz RN, MA, CDE
Organization
NYU Langone Health
Jeniece.ilkowitz@nyulangone.org
212-263-9910

Study Officials

  • Bonita Franklin, MD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 13, 2017

Study Start

November 1, 2015

Primary Completion

July 13, 2018

Study Completion

July 13, 2018

Last Updated

March 16, 2020

Results First Posted

March 16, 2020

Record last verified: 2020-03

Locations

US(1)