Can Glucose Monitoring Improve (CGMi Study)

August 3, 2021 updated by: Lori Laffel, Joslin Diabetes Center

Optimizing CGM Use and Metabolic Outcomes in Youth With Type 1 Diabetes

The purpose of this 2-year randomized controlled trial (RCT) is to implement and evaluate a family-focused behavioral teamwork intervention aimed at overcoming barriers to sustained continuous glucose monitoring (CGM) use in youth with type 1 diabetes (T1D). We hypothesize that CGM implemented with a family-focused, behavioral teamwork intervention will result in sustained CGM use and greater improvement in A1c compared to routine implementation of CGM.

Study Overview

Status

Completed

Conditions

Detailed Description

Consistent CGM use in youth with T1D has been difficult to sustain historically. Youth with T1D and their families have routinely felt burden related to the introduction of this technology into their care management. Additionally, there can be difficulties with calibration, skin irritation, frequent skips, excessive or nuisance alarms and inaccurate readings which often lead to diminished use or discontinuation entirely. The purpose of this protocol is to implement and evaluate a family-focused behavioral teamwork intervention aimed at overcoming barriers to sustained CGM use in youth with T1D. In this 2-year RCT, we will assess the long-term acceptability and durability of CGM use and its associated glycemic and psychological outcomes in youth with T1D and their families. We will randomize 120 families to one of two groups: (1) CGM implemented according to usual care (CGM-Usual Care, CGM-UC) or (2) CGM implemented with a family teamwork intervention (CGM-Teamwork, CGM-TW). This intervention will allow participants and families to overcome barriers to sustained CGM use and achieve glycemic benefits that have been afforded to adults using CGM as demonstrated in other research. In year 1, all CGM supplies will be provided and covered by study resources. In year 2, study participants will be asked to cover the costs associated with sensor use and any costs associated with replacement of CGM components in a manner consistent with routine clinical care as the investigators believe that it is important to assess durability of CGM use in clinical practice.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 8-17 years
  • Planning to be living at home for 2 years
  • Type 1 diabetes of at least 1 year duration
  • Daily insulin dose ≥0.5 units/kg
  • A1c ≥6.5% and ≤10.0%
  • Insulin therapy with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (≥3 injections/day)
  • Blood glucose (BG) monitoring frequency ≥4 times/day
  • Agreement to wear a CGM device
  • Fluency in English for child and parent/guardian
  • Stable living situation for ≥6 months (e.g., no Department of Youth Services Involvement)
  • Joslin Clinic attendance: At least one Joslin Clinic visit in last year AND Anticipated care at Joslin Clinic for duration of study

Exclusion Criteria:

  • Consistent CGM use, defined as 6+ days/week during the previous 6 months
  • History of severe, life-threatening skin reactions to the adhesive used with the CGM device
  • Pregnancy in the youth participant or intention to become pregnant within the next 2 years
  • Significant developmental or cognitive disorder in the youth or parent/guardian that would prevent full participation in a family-based, behavioral intervention or implementation of CGM
  • Inpatient psychiatric admission within the previous 6 months
  • Participation in another intervention study during the previous 3 months
  • Intent to enroll in another intervention study during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: CGM-Usual Care
  • Routine CGM education
EXPERIMENTAL: CGM-Teamwork
  • Routine CGM education
  • CGM Family Teamwork Intervention
The family-focused behavioral intervention targets barriers associated with sustained CGM use in youth with type 1 diabetes. During months 1-18, families in the intervention group will participate in the intervention at each study visit for about an additional 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in glycemic control, assessed by hemoglobin A1c
Time Frame: Baseline and 1 year
Baseline and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in psychosocial factors (e.g., self-efficacy, fear of hypoglycemia, quality of life, diabetes-specific family conflict, diabetes responsibility sharing, diabetes-specific burden, anxiety, depressive symptoms)
Time Frame: Baseline and 1 year
Baseline and 1 year
Change in glycemic control, assessed by hemoglobin A1c
Time Frame: 1 year and 2 years
Durability of the intervention will be assessed by change in A1c from 1 year to 2 years
1 year and 2 years
Change in psychosocial factors (e.g., self-efficacy, fear of hypoglycemia, quality of life, diabetes-specific family conflict, diabetes responsibility sharing, diabetes-specific burden, anxiety, depressive symptoms)
Time Frame: 1 year and 2 years
1 year and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 11, 2011

First Posted (ESTIMATE)

November 16, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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