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A Reinforcement Approach to Increase Use of CGM

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ClinicalTrials.gov Identifier: NCT02907346
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

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:

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: CGM Not Applicable

Detailed Description:

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:

  1. To estimate how well a reinforcement intervention increases usage of CGM. The proportion of days on which participants wear the CGM will be determined as well as the number of weeks during which CGM is worn at least 5 days. We will compare usage rates in the pilot trial to historical control data of patients initiating CGM.
  2. To evaluate the association between CGM usage and A1c. We expect A1c will decrease over time in patients who receive the reinforcement intervention. Patients who continue using the CGM are expected to have greater decreases in A1c than patients who discontinue its usage.

Evaluations will be conducted at time of CGM initiation, and 6, 13, 19, 26, and 39 weeks after treatment initiation to assess effects of the intervention and estimate effect sizes.

In addition to the primary aims, secondary outcomes will also be evaluated. Continued use of CGM is expected to improve aspects of diabetes management and daily functioning. Predictors of continued CGM usage and improvements in A1c will also be evaluated.

Results from this pilot study will be instrumental for guiding a subsequent, larger and longer term randomized study for evaluating reinforcement interventions for improving uptake of CGM, other diabetes-related adherence behaviors, and long-term outcomes.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Reinforcement Approach to Increase Use of CGM
Study Start Date : September 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Reinforcement for wearing CGM
The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data.
Device: CGM
The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data.
Other Name: Reinforcement for CGM wear




Primary Outcome Measures :
  1. Change in the Proportion of days participants wear the CGM [ Time Frame: up to 39 weeks ]
    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.

  2. Change in the number of weeks participants wear the CGM on at least 5 days [ Time Frame: up to 39 weeks ]
    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.

  3. Change in A1c [ Time Frame: up to 39 weeks ]
    Change in A1c will be evaluated at the week 6, 13, 19, 26 and 39 week study visits by finger prick (DCA Vantage,Siemons).



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Ages Eligible for Study:   13 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 13-26 years old;
  2. diagnosis of type 1 diabetes (T1D) >12 months via ADA guidelines
  3. average A1c >7.5% and <14% during the year before study entry, and most recent A1c >7.5% but <14%;
  4. have ordered and received a CGM, but have not used a CGM >3 days a week on average during the past 6 months.
  5. test blood glucose levels at least 2 times per day on average;
  6. access to a computer with internet for uploading CGM data;
  7. access to a cell phone to communicate with research staff;
  8. 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907346


Contacts
Contact: Marcia DeSousa 203-737-6877 DeSousa@uchc.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Marcia DeSousa, BA    203-737-6877    DeSousa@uchc.edu   
Principal Investigator: William Tamborlane, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: William Tamborlane, MD Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02907346     History of Changes
Other Study ID Numbers: 1603017504
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases