- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01472159
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
Intervention / Treatment
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
|
|
EXPERIMENTAL: CGM-Teamwork
|
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.
General Publications
- McGill DE, Volkening LK, Butler DA, Harrington KR, Katz ML, Laffel LM. Baseline Psychosocial Characteristics Predict Frequency of Continuous Glucose Monitoring in Youth with Type 1 Diabetes. Diabetes Technol Ther. 2018 Jun;20(6):434-439. doi: 10.1089/dia.2018.0037. Epub 2018 May 4.
- Telo GH, Volkening LK, Butler DA, Laffel LM. Salient characteristics of youth with type 1 diabetes initiating continuous glucose monitoring. Diabetes Technol Ther. 2015 Jun;17(6):373-8. doi: 10.1089/dia.2014.0290. Epub 2015 Mar 6.
- Volkening LK, Gaffney KC, Katz ML, Laffel LM. Recruitment Into a Pediatric Continuous Glucose Monitoring RCT. J Diabetes Sci Technol. 2017 Jan;11(1):100-107. doi: 10.1177/1932296816656208. Epub 2016 Jul 9.
- Giani E, Snelgrove R, Volkening LK, Laffel LM. Continuous Glucose Monitoring (CGM) Adherence in Youth With Type 1 Diabetes: Associations With Biomedical and Psychosocial Variables. J Diabetes Sci Technol. 2017 May;11(3):476-483. doi: 10.1177/1932296816676280. Epub 2016 Nov 1.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-28
- R01DK089349 (NIH)
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.
Clinical Trials on Type 1 Diabetes
-
Poznan University of Medical SciencesUnknownDiabetes Mellitus Type 1 | Remission of Type 1 Diabetes | Chronic Complications of DiabetesPoland
-
Eledon PharmaceuticalsWithdrawnBrittle Type 1 Diabetes MellitusUnited States
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Hoffmann-La RocheCompletedType 2 Diabetes, Type 1 DiabetesAustria, United Kingdom
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
NYU Langone HealthNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
Rabin Medical CenterDreaMed DiabetesRecruiting
Clinical Trials on CGM Family Teamwork Intervention
-
Joslin Diabetes CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedType 1 Diabetes MellitusUnited States
-
Jaeb Center for Health ResearchThe Leona M. and Harry B. Helmsley Charitable Trust; Indiana University School...CompletedType 1 Diabetes MellitusUnited States
-
Baylor College of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University MariborNot yet recruitingHeart Diseases | Cardiovascular Diseases | Coronary Artery Disease | Coronary Heart Disease | Lifestyle | Continuous Glucose Monitoring | Behaviour Change | CGM | Visualization | Visual Analytics
-
Ersta Sköndal University CollegeCompleted
-
Mental Health Services in the Capital Region, DenmarkTrygFonden, Denmark; Sektion for Tværsektoriel forskning - Region HovedstadenRecruitingChild | Parenting | Resilience | Mental Disorder | Prevention | FamilyDenmark
-
Ersta Sköndal University CollegeCompletedPalliative CareSweden
-
Northwell HealthCompletedPostpartum Depression | Unspecified Child Maltreatment, Suspected | Unspecified Child Maltreatment, ConfirmedUnited States
-
University of MiamiNational Institute on Drug Abuse (NIDA)CompletedProblem BehaviorUnited States
-
Pakistan Institute of Living and LearningUniversity of Manchester; Dow University of Health Sciences; Abbasi Shaheed HospitalCompleted