Type 1 Diabetes MellitusCGM-TeensNCT00945659
Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control
A study testing Continuous Glucose Sensor and CGS + Behavior Therapy in people with Type 1 Diabetes Mellitus, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
The incorporation of continuous glucose sensors (CGS) into management of type 1 diabetes in adolescence could improve treatment outcomes. But, behavioral barriers may prevent adolescents from enjoying optimal benefits from this new technology. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Continuous Glucose Sensor and CGS + Behavior Therapy
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age of adolescent > 11 years and < 17 years. This age range was chosen because families of adolescents often struggle with diabetes management. Youths > 18 years old may be likely to leave home during the study.
- Diagnosis of type 1 diabetes based on the clinician's best judgment regarding the adolescent's proper diagnostic category.
- Duration of type 1 diabetes > 2 years or > 1 year with negligible stimulated c-peptide level, to exclude those with significant residual pancreatic insulin production.
- Treatment of diabetes for the 6 months prior to enrollment must consist of an intensified regimen including either daily use of an insulin pump or 3 or more daily insulin injections with pre-meal insulin doses calculated using a correction factor that considers prevailing blood glucose levels and planned carbohydrate intake.
- Adolescent must have established diabetes care at a participating Nemours Children's Clinic site as evidenced by at least two diabetes clinic visits within the prior 12 months.
- Most recent HbA1C > 7.5% and < 10.0% or mean HbA1C over the prior 12 months within that same range.
- Intention to remain in the same region and to maintain diabetes care at the enrolling center for 12 months.
- Family has working telephone service.
Who cannot join
- Youth has not used a CGM device with real-time glucose feedback for clinical management of diabetes within the prior 6 months. Intermittent or one-time use of "blinded" CGM devices for retrospective analysis only is permissible.
- Absence of any other medical conditions that, in the opinion of the attending endocrinologist, would impede completion of the study protocol.
- Youths may not be on daily glucocorticoid medications due to hyperglycemic effects of these agents.
- Not enrolled in special education for mental retardation, autism or severe behavior disorders.
- Child not in an inpatient psychiatric unit or day treatment program during the 6 months prior to enrollment.
- Primary diabetes caregiver not diagnosed or in treatment for major depression, psychosis, bipolar disorder or substance use disorder within the 6 months prior to enrollment; Child not in an inpatient psychiatric unit or day treatment program during the 6 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this study
The incorporation of continuous glucose sensors (CGS) into management of type 1 diabetes in adolescence could improve treatment outcomes. But, behavioral barriers may prevent adolescents from enjoying optimal benefits from this new technology. This study will randomize adolescents (11 to not yet 17 years old) with type 1 diabetes for at least 2 years who are not achieving targeted HbA1c levels (> 7.5%) to continue in standard care (SC), to add continuous glucose monitoring (CGM) to their care with appropriate education and medical management (CGS) or to add CGM to their care as above but to also receive support and assistance from a behavior therapist who will assist the patient and family in optimizing the adolescents' therapeutic benefit from CGS (CGS+BT). A variety of outcomes will be measured, including blood glucose control, quality of life, and CGS satisfaction and impact. An enrollment criterion for this study is that the adolescent must have established consistent care for type 1 diabetes at a Nemours Children's Clinic location either in Wilmington, DE, Philadelphia, PA, Orlando, FL or Pensacola, FL for at least 12 months prior to enrollment in the study. Adolescents treated elsewhere are not eligible to enroll in the study.
Read the detailed description
Management of type 1 diabetes mellitus (T1DM) in adolescents is very difficult and innovative approaches are needed to help them achieve better glycemic control and behavioral outcomes. Continuous glucose sensors (CGS) have been refined progressively and provide acceptably accurate, nearly continuous estimates of glucose levels and trends. This increased quality and quantity of glucose data could be an excellent adjunct to conventional self-monitoring of blood glucose, permitting more informed diabetes decision-making. CGS could yield medical, educational and psychological benefits for adolescents with T1DM, but those with extremely variable self-management habits and suboptimal glycemic control may not realize these benefits readily. We hypothesize that a targeted, family-focused behavioral intervention could optimize benefit from adding CGS to T1DM therapy for youths with glycosylated hemoglobin (HbA1c) > 7.5%. A multi-site sample of 150 adolescents with T1DM and HbA1C of 7.5% to 10.0% will be randomized to either Standard Care for T1DM (SC), or to augmentation of SC with 9 months' use of a CGS device (CGS) or use of a CGS device supplemented with a targeted behavior therapy intervention (CGS+BT). Multiple measures of glycemic control, glycemic variability and health care use will be obtained during the study and there will be periodic assessments of demographic factors, diabetes self-management, family relations and psychological adjustment. Three specific aims will be addressed: 1. Evaluate whether CGS+BT yields more improvement in glycemic outcomes than CGS or SC; 2. Evaluate whether CGS+BT yields more improvement in behavioral outcomes than CGS or SC; and 3. Identify behavioral variables that mediate and moderate glycemic benefit from use of the CGS device. The study will also compare the cost effectiveness of CGS and CGS+BT relative to SC and evaluate the predictive utility of various indices of glycemic variability in youths. We hypothesize that, compared with SC and CGS, CGS+BT will yield significantly better biomedical outcomes (HbA1C; severe hypoglycemia; glycemic variability; proportion of glucose readings in the normal range) and behavioral outcomes (treatment adherence; parent adolescent teamwork; diabetes-related family conflict; quality of life; fear of hypoglycemia; and treatment satisfaction). After the 9 month randomized trial, all youths will be allowed to use the CGS device during an additional 3-month continuation phase. Statistical analyses will be based on individual growth modeling techniques. The application capitalizes on the Principal Investigator's prior and ongoing funded research on family management of T1DM, including trials of family-focused behavioral interventions, intensive therapy regimens, and clinical evaluations of continuous glucose sensors. The proposed study will determine whether a targeted behavioral intervention improves CGS benefits among adolescents with previously inadequate glycemic control. These results could demonstrate that adolescents with previously suboptimal diabetic control could realize multiple benefits from CGS use if they are provided with a specialized behavioral intervention.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Continuous Glucose Sensor, Standard Care, CGS + Behavior Therapy
- 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.
Continuous Glucose SensorDevice
Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
Standard CareOther
Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
CGS + Behavior TherapyBehavioural
Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments. Receives: Other: Standard Care |
| Continuous Glucose Sensor | Active comparator | Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms. Receives: Device: Continuous Glucose Sensor |
| CGS + Behavior Therapy | Experimental | Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care. Receives: Behavioral: CGS + Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c) expressed as a percentage of hemoglobin molecules bound to glucose.
Measured: Baseline, 3, 6, 9 months
Secondary outcomes (12)
Diabetes Technology Questionnaire-Adolescents
Adolescent's total score on the DTQ-Current items. Range 30-150. Higher scores indicate more favorable satisfaction with and impact of the package of diabetes technology (e.g. pump, meter, CGM, etc.) in use by the patient during the prior 3 months.
Measured: Baseline, 3 6, 9 months
Diabetes Technology Questionnaire-Parents' Total Scores on DTQ Current Items
Parents' ratings of impact and satisfaction with the diabetes devices currently in use (e.g. pump, meter, CGM etc.) Score range from 30-150. Higher score signify greater satisfaction and impact.
Measured: Baseline, 3, 6, 9 months
Blood Glucose Monitoring Communication Questionnaire-Adolescent
Adolescent report of communication with parents about blood glucose monitoring and results. Range 8-24. Higher scores indicate more negative communication about BG results.
Measured: Baseline, 3, 6, 9 months
Blood Glucose Monitoring Communication Questionnaire-Parents
Parents perspectives of communication with adolescent around blood glucose monitoring and results. Score range 8-24. Higher scores signify more negative communication about BG results.
Measured: Baseline, 3, 6, 9 months
Diabetes Family Conflict Scale-Adolescent
Adolescent ratings of degree of diabetes-related family conflict. Score range 19-57. Higher scores indicate more frequent family conflict around diabetes.
Measured: Baseline, 3, 6, 9 months
Diabetes Family Conflict Scale-Parent
Parents' ratings of degree of diabetes-related family conflict. Score range 19-57. Higher scores indicate more family conflict around diabetes.
Measured: Baseline, 3, 6, 9 months
Diabetes Family Responsibility Questionnaire-Adolescent
Adolescent's self-ratings of their degree of responsibility for 38 diabetes tasks. Score range 0-76. Lower scores indicate greater adolescent responsibility for diabetes care.
Measured: Baserline, 3, 6, 9 months
Diabetes Family Responsibility Questionnaire-Parent
Parent ratings of adolescent's degree of responsibility for 38 diabetes tasks. Score range 0-76. Lower scores indicate great adolescent responsibility for diabetes care tasks.
Measured: Baseline, 3, 6, 9 months
Diabetes Self Management Profile-Adolescent
Adolescent self-report of diabetes management behaviors. Score range 0-86. Higher scores indicate more meticulous diabetes treatment adherence.
Measured: Baseline, 3, 6, 9 months
Diabetes Self Management Profile-Parent
Parent report of adolescent's diabetes self-management behaviors. Score range 0-86. Higher scores indicate more meticulous diabetes treatment adherence.
Measured: Baseline, 3, 6, 9 months
Hypoglycemia Fear Survey-Adolescent
Adolescent worry and behavior related to apprehension of low BG episodes. Score range 24-72. Higher scores indicate greater fear and avoidance of hypoglycemia
Measured: Baseline, 3, 6, 9 months
Hypoglycemia Fear Survey-Parent
Parental worry and behavior related to apprehension of low BG events. Score range 24-72. Higher scores indicate greater parental fear and avoidance of hypoglycemia.
Measured: Baseline, 3, 6, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startAug 2009
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 group (Standard Care: Continuous Glucose Monitor; Continuous Glucose Monitor + Behavior Therapy) X 4 time points (0, 3, 6, and 9 months) Repeated measures randomized treatments design.
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Wysocki, Nemours Children's Clinic
- Investigators
- Tim Wysocki, Ph.D., Principal investigator, Nemours Children's Clinic Jacksonville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945659
- Sponsor's protocol ID
- 1R01DK080831
- Other IDs
- 1R01DK080831
- Acronym
- CGM-Teens
- Status last verified
- Aug 2018
- First submitted
- 23 Jul 2009
- Last updated
- 10 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control
- ClinicalTrials.gov ID
- NCT00945659
- Acronym / sponsor ID
- CGM-Teens / 1R01DK080831
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2009
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Posted 10 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incorporation of continuous glucose sensors (CGS) into management of type 1 diabetes in adolescence could improve treatment outcomes. But, behavioral barriers may prevent adolescents from enjoying optimal benefits from this new technology. This study will randomize adolescents (11 to not yet 17 years old) with type 1 diabetes for at least 2 years who are not achieving targeted HbA1c levels (> 7.5%) to continue in standard care (SC), to add continuous glucose monitoring (CGM) to their care with appropriate education and medical management (CGS) or to add CGM to their care as above but to also receive support and assistance from a behavior therapist who will assist the patient and family in optimizing the adolescents' therapeutic benefit from CGS (CGS+BT). A variety of outcomes will be measured, including blood glucose control, quality of life, and CGS satisfaction and impact. An enrollment criterion for this study is that the adolescent must have established consistent care for type 1 diabetes at a Nemours Children's Clinic location either in Wilmington, DE, Philadelphia, PA, Orlando, FL or Pensacola, FL for at least 12 months prior to enrollment in the study. Adolescents treated elsewhere are not eligible to enroll in the study.
Detailed description
Management of type 1 diabetes mellitus (T1DM) in adolescents is very difficult and innovative approaches are needed to help them achieve better glycemic control and behavioral outcomes. Continuous glucose sensors (CGS) have been refined progressively and provide acceptably accurate, nearly continuous estimates of glucose levels and trends. This increased quality and quantity of glucose data could be an excellent adjunct to conventional self-monitoring of blood glucose, permitting more informed diabetes decision-making. CGS could yield medical, educational and psychological benefits for adolescents with T1DM, but those with extremely variable self-management habits and suboptimal glycemic control may not realize these benefits readily. We hypothesize that a targeted, family-focused behavioral intervention could optimize benefit from adding CGS to T1DM therapy for youths with glycosylated hemoglobin (HbA1c) > 7.5%. A multi-site sample of 150 adolescents with T1DM and HbA1C of 7.5% to 10.0% will be randomized to either Standard Care for T1DM (SC), or to augmentation of SC with 9 months' use of a CGS device (CGS) or use of a CGS device supplemented with a targeted behavior therapy intervention (CGS+BT). Multiple measures of glycemic control, glycemic variability and health care use will be obtained during the study and there will be periodic assessments of demographic factors, diabetes self-management, family relations and psychological adjustment. Three specific aims will be addressed: 1. Evaluate whether CGS+BT yields more improvement in glycemic outcomes than CGS or SC; 2. Evaluate whether CGS+BT yields more improvement in behavioral outcomes than CGS or SC; and 3. Identify behavioral variables that mediate and moderate glycemic benefit from use of the CGS device. The study will also compare the cost effectiveness of CGS and CGS+BT relative to SC and evaluate the predictive utility of various indices of glycemic variability in youths. We hypothesize that, compared with SC and CGS, CGS+BT will yield significantly better biomedical outcomes (HbA1C; severe hypoglycemia; glycemic variability; proportion of glucose readings in the normal range) and behavioral outcomes (treatment adherence; parent adolescent teamwork; diabetes-related family conflict; quality of life; fear of hypoglycemia; and treatment satisfaction). After the 9 month randomized trial, all youths will be allowed to use the CGS device during an additional 3-month continuation phase. Statistical analyses will be based on individual growth modeling techniques. The application capitalizes on the Principal Investigator's prior and ongoing funded research on family management of T1DM, including trials of family-focused behavioral interventions, intensive therapy regimens, and clinical evaluations of continuous glucose sensors. The proposed study will determine whether a targeted behavioral intervention improves CGS benefits among adolescents with previously inadequate glycemic control. These results could demonstrate that adolescents with previously suboptimal diabetic control could realize multiple benefits from CGS use if they are provided with a specialized behavioral intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 group (Standard Care: Continuous Glucose Monitor; Continuous Glucose Monitor + Behavior Therapy) X 4 time points (0, 3, 6, and 9 months) Repeated measures randomized treatments design.
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Other: Standard CareStandard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments. |
| Continuous Glucose Sensor | Active comparator | Device: Continuous Glucose SensorPatients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms. |
| CGS + Behavior Therapy | Experimental | Behavioral: CGS + Behavior TherapyPatients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age of adolescent > 11 years and < 17 years. This age range was chosen because families of adolescents often struggle with diabetes management. Youths > 18 years old may be likely to leave home during the study.
- Diagnosis of type 1 diabetes based on the clinician's best judgment regarding the adolescent's proper diagnostic category.
- Duration of type 1 diabetes > 2 years or > 1 year with negligible stimulated c-peptide level, to exclude those with significant residual pancreatic insulin production.
- Treatment of diabetes for the 6 months prior to enrollment must consist of an intensified regimen including either daily use of an insulin pump or 3 or more daily insulin injections with pre-meal insulin doses calculated using a correction factor that considers prevailing blood glucose levels and planned carbohydrate intake.
- Adolescent must have established diabetes care at a participating Nemours Children's Clinic site as evidenced by at least two diabetes clinic visits within the prior 12 months.
Key exclusion criteria (6 listed)
- Youth has not used a CGM device with real-time glucose feedback for clinical management of diabetes within the prior 6 months. Intermittent or one-time use of "blinded" CGM devices for retrospective analysis only is permissible.
- Absence of any other medical conditions that, in the opinion of the attending endocrinologist, would impede completion of the study protocol.
- Youths may not be on daily glucocorticoid medications due to hyperglycemic effects of these agents.
- Not enrolled in special education for mental retardation, autism or severe behavior disorders.
- Child not in an inpatient psychiatric unit or day treatment program during the 6 months prior to enrollment.
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 |
|---|---|---|
| Continuous Glucose SensorEducation and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management. | Device | Continuous Glucose Sensor |
| Standard CareIntensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses. | Other | Standard Care |
| CGS + Behavior TherapyPatients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care. | Behavioural | CGS + Behavior Therapy |
Primary outcome
Glycated Hemoglobin (HbA1c)
Time frame: Baseline, 3, 6, 9 months
Glycated hemoglobin (HbA1c) expressed as a percentage of hemoglobin molecules bound to glucose.
12 secondary outcomes
Diabetes Technology Questionnaire-Adolescents
Time frame: Baseline, 3 6, 9 months
Diabetes Technology Questionnaire-Parents' Total Scores on DTQ Current Items
Time frame: Baseline, 3, 6, 9 months
Blood Glucose Monitoring Communication Questionnaire-Adolescent
Time frame: Baseline, 3, 6, 9 months
Blood Glucose Monitoring Communication Questionnaire-Parents
Time frame: Baseline, 3, 6, 9 months
Diabetes Family Conflict Scale-Adolescent
Time frame: Baseline, 3, 6, 9 months
Diabetes Family Conflict Scale-Parent
Time frame: Baseline, 3, 6, 9 months
Diabetes Family Responsibility Questionnaire-Adolescent
Time frame: Baserline, 3, 6, 9 months
Diabetes Family Responsibility Questionnaire-Parent
Time frame: Baseline, 3, 6, 9 months
Diabetes Self Management Profile-Adolescent
Time frame: Baseline, 3, 6, 9 months
Diabetes Self Management Profile-Parent
Time frame: Baseline, 3, 6, 9 months
Hypoglycemia Fear Survey-Adolescent
Time frame: Baseline, 3, 6, 9 months
Hypoglycemia Fear Survey-Parent
Time frame: Baseline, 3, 6, 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tim Wysocki, Ph.D. principal investigator
Nemours Children's Clinic Jacksonville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Sensor and CGS + Behavior Therapy in people with Type 1 Diabetes Mellitus, run by Nemours Children's Clinic 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 8 inclusion and 6 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 Sep 2018. 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?
Yes. Results are posted in the registry (first posted 10 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glycated Hemoglobin (HbA1c) (time frame: Baseline, 3, 6, 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2018.