Type 1 DiabetesNCT01472159
Can Glucose Monitoring Improve (CGMi Study)
A study testing CGM Family Teamwork Intervention in people with Type 1 Diabetes, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- CGM Family Teamwork Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- CGM Family Teamwork Intervention
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM Family Teamwork InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CGM-Usual Care | No intervention | * Routine CGM education |
| CGM-Teamwork | Experimental | * Routine CGM education
* CGM Family Teamwork Intervention Receives: Behavioral: CGM Family Teamwork Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycemic control, assessed by hemoglobin A1c
Measured: Baseline and 1 year
Secondary outcomes (3)
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)
Measured: Baseline and 1 year
Change in glycemic control, assessed by hemoglobin A1c
Durability of the intervention will be assessed by change in A1c from 1 year to 2 years
Measured: 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)
Measured: 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research
- Responsible party
- Principal investigator, Lori Laffel, Joslin Diabetes Center
- Investigators
- Lori Laffel, MD, MPH, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472159
- Sponsor's protocol ID
- 2010-28
- Other IDs
- R01DK089349
- Status last verified
- Aug 2021
- First submitted
- 9 Nov 2011
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 29727245Telo 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.
PubMed 25749206Volkening 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.
PubMed 27340247Giani 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.
PubMed 27807014
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing CGM Use and Metabolic Outcomes in Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01472159
- Acronym / sponsor ID
- 2010-28
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research
- Study start
- Oct 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM-Usual Care | No intervention | –* Routine CGM education |
| CGM-Teamwork | Experimental | Behavioral: CGM Family Teamwork Intervention* Routine CGM education * CGM Family Teamwork Intervention |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGM Family Teamwork InterventionThe 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. | Behavioural | CGM-Teamwork |
Primary outcome
Change in glycemic control, assessed by hemoglobin A1c
Time frame: Baseline and 1 year
3 secondary outcomes
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
Change in glycemic control, assessed by hemoglobin A1c
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Results publication: PubMed 29727245McGill 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.
- Results publication: PubMed 25749206Telo 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.
- Results publication: PubMed 27340247Volkening 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.
- Results publication: PubMed 27807014Giani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Laffel, MD, MPH principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM Family Teamwork Intervention in people with Type 1 Diabetes, run by Joslin Diabetes Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycemic control, assessed by hemoglobin A1c (time frame: Baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01472159, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.