Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Can Glucose Monitoring Improve (CGMi Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Jaeb Center for Health Research
Information provided by (Responsible Party):
Lori Laffel, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01472159
First received: November 9, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Behavioral: CGM Family Teamwork Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Optimizing CGM Use and Metabolic Outcomes in Youth With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • Change in glycemic control, assessed by hemoglobin A1c [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in glycemic control, assessed by hemoglobin A1c [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
    Durability of the intervention will be assessed by change in A1c from 1 year to 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 ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: October 2011
Estimated Study Completion Date: April 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: CGM-Usual Care
  • Routine CGM education
Experimental: CGM-Teamwork
  • Routine CGM education
  • CGM Family Teamwork Intervention
Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472159

Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Jaeb Center for Health Research
Investigators
Principal Investigator: Lori Laffel, MD, MPH Joslin Diabetes Center
  More Information

No publications provided

Responsible Party: Lori Laffel, Chief, Pediatric, Adolescent, & Young Adult Section; Investigator, Genetics & Epidemiology Section, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01472159     History of Changes
Other Study ID Numbers: 2010-28, R01DK089349
Study First Received: November 9, 2011
Last Updated: July 7, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 19, 2014