NCT02907346

Brief Summary

The purpose of this pilot project is to evaluate the effectiveness of a behavioral economic intervention to increase use of continuous glucose monitors (CGM) in adolescents and young adults with T1D. This study will be done in conjunction with Nancy Petry, PhD and her research team at University of Connecticut School of Medicine (UConn Health). The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data. A 6-month pilot trial will be conducted with up to 20 patients receiving the intervention. The specific aims are:

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

2.8 years

First QC Date

July 25, 2016

Last Update Submit

August 26, 2020

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

  • Change in the Proportion of days participants wear the CGM

    CGM data uploaded to a CGM tracking website (e.g., Dexcom CLARITY™, Carelink) will be used to calculate the change in the proportion of days when the patient wore the CGM. At the 6, 13, 19, 26 and 39 week study visits, data will be uploaded and exported into an Excel file to calculate the days.

    up to 39 weeks

  • Change in the number of weeks participants wear the CGM on at least 5 days

    CGM data uploaded to a CGM tracking website (e.g., Dexcom CLARITY™, Carelink) will be used to calculate the change in the number of weeks when the CGM is worn at least 5 days. At the 6, 13, 19, 26 and 39 week study visits, CGM data will be uploaded and exported into an Excel file to calculate the number of weeks when it is worn at least 5 days.

    up to 39 weeks

  • Change in A1c

    Change in A1c will be evaluated at the week 6, 13, 19, 26 and 39 week study visits by finger prick (DCA Vantage,Siemons).

    up to 39 weeks

Study Arms (1)

Reinforcement for wearing CGM

EXPERIMENTAL

The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data.

Behavioral: Reinforcement for wearing CGM

Interventions

Reinforcement for wearing CGMBEHAVIORAL

The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data.

Also known as: Reinforcement for CGM wear
Reinforcement for wearing CGM

Eligibility Criteria

Age13 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 13-26 years old;
  • diagnosis of type 1 diabetes (T1D) \>12 months via ADA guidelines
  • average A1c \>7.5% and \<14% during the year before study entry, and most recent A1c \>7.5% but \<14%;
  • have ordered and received a CGM, but have not used a CGM \>3 days a week on average during the past 6 months.
  • test blood glucose levels at least 2 times per day on average;
  • access to a computer with internet for uploading CGM data;
  • access to a cell phone to communicate with research staff;
  • English speaking, able to read at \>5th grade level, and pass an informed consent quiz; and adequate knowledge of insulin dosing and dietary recommendations for managing T1D.

You may not qualify if:

  • have a major psychiatric or neurocognitive disorder (e.g., severe learning impairment) that would inhibit participation;
  • have a major visual impairment;
  • have a significant other medical condition that impacts diabetes management (e.g., rheumatoid arthritis, or other condition that requires steroid treatment);
  • plan to switch insulin delivery mode (injection to pump or vice versa) in the next 12 months, or have recently switched.
  • Fail to complete the baseline phase wearing the CGM.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, 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

Study Officials

  • William Tamborlane, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

September 20, 2016

Study Start

September 1, 2016

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

August 31, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)