A Reinforcement Approach to Increase Use of CGM

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:

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Reinforcement for wearing CGM

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
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reinforcement for wearing CGM; The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data.	Behavioral: Reinforcement for wearing CGM; The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data.; Other Names: Reinforcement for CGM wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: William Tamborlane, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 1603017504; 1DP3DK097705-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO