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CompletedNCT00945659CGM-TeensUpdated Sep 10, 2018Results posted

Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control

An interventional study of Continuous Glucose Sensor and Standard Care in Type 1 Diabetes Mellitus, sponsored by Nemours Children's Clinic. Completed at 1 site in United States. Open to participants aged 11 Years to 16 Years. Per ClinicalTrials.gov, last updated 2018-09-10.

Sponsored by Nemours Children's Clinic · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
11 Years to 16 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Type 1 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 116 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Nemours Children's Clinic is the lead sponsor of 127 studies on the registry; 27 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. Diagnosis of type 1 diabetes based on the clinician's best judgment regarding the adolescent's proper diagnostic category.
  3. 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.
  4. 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.
  5. 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.
  6. Most recent HbA1C > 7.5% and \< 10.0% or mean HbA1C over the prior 12 months within that same range.
  7. Intention to remain in the same region and to maintain diabetes care at the enrolling center for 12 months.
  8. Family has working telephone service.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Absence of any other medical conditions that, in the opinion of the attending endocrinologist, would impede completion of the study protocol.
  3. Youths may not be on daily glucocorticoid medications due to hyperglycemic effects of these agents.
  4. Not enrolled in special education for mental retardation, autism or severe behavior disorders.
  5. Child not in an inpatient psychiatric unit or day treatment program during the 6 months prior to enrollment.
  6. 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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
116 participants (actual)

Study arms

  • Active comparator
    Standard Care

    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.

    Other: Standard Care

  • Active comparator
    Continuous Glucose Sensor

    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.

    Device: Continuous Glucose Sensor

  • Experimental
    CGS + Behavior Therapy

    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.

    Behavioral: CGS + Behavior Therapy

Interventions

  • DeviceContinuous Glucose Sensor

    Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.

  • OtherStandard Care

    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.

  • BehavioralCGS + Behavior Therapy

    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.

06

What researchers measure

Primary outcomes

  1. Glycated Hemoglobin (HbA1c)

    Glycated hemoglobin (HbA1c) expressed as a percentage of hemoglobin molecules bound to glucose.

    Time frame: Baseline, 3, 6, 9 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 3 6, 9 months

  2. 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.

    Time frame: Baseline, 3, 6, 9 months

  3. 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.

    Time frame: Baseline, 3, 6, 9 months

  4. 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.

    Time frame: Baseline, 3, 6, 9 months

  5. 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.

    Time frame: Baseline, 3, 6, 9 months

  6. 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.

    Time frame: Baseline, 3, 6, 9 months

  7. 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.

    Time frame: Baserline, 3, 6, 9 months

  8. 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.

    Time frame: Baseline, 3, 6, 9 months

  9. Diabetes Self Management Profile-Adolescent

    Adolescent self-report of diabetes management behaviors. Score range 0-86. Higher scores indicate more meticulous diabetes treatment adherence.

    Time frame: Baseline, 3, 6, 9 months

  10. 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.

    Time frame: Baseline, 3, 6, 9 months

  11. 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

    Time frame: Baseline, 3, 6, 9 months

  12. 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.

    Time frame: Baseline, 3, 6, 9 months

07

Results

Posted Sep 10, 2018

Participant flow

Participant flow — Overall Study
MilestoneStandard CareContinuous Glucose SensorCGS + Behavior Therapy
Started394037
Baseline394037
3-months383935
6-months312925
9-months322020
12-months322020
Completed322020
Not completed72017
Withdrew: Lost to follow-up72017

Outcome measures

PrimaryGlycated Hemoglobin (HbA1c)

Glycated hemoglobin (HbA1c) expressed as a percentage of hemoglobin molecules bound to glucose.

Time frame:
Baseline, 3, 6, 9 months
Reported as:
Mean · percentage of hemoglobin molecules
Glycated Hemoglobin (HbA1c)
percentage of hemoglobin moleculesStandard CareContinuous Glucose SensorCGS + Behavior Therapy
Baseline8.84 ± 0.959.03 ± 1.079.24 ± 0.83
3-Months9.14 ± 1.389.06 ± 1.108.96 ± 0.84
6-Months8.95 ± 1.149.35 ± 1.309.09 ± 1.71
9-Months8.96 ± 1.049.51 ± 1.379.05 ± 1.14
Statistical analysis
  • Standard Care vs Continuous Glucose Sensor · Generalized Estimating Equation · p = 0.86 · Mean difference (net): -.003 · 95% CI -0.43 to 0.36
  • Standard Care vs CGS + Behavior Therapy · Generalized Estimating Equation · p = 0.03 · Mean difference (net): -0.41 · 95% CI -0.78 to -0.04
SecondaryDiabetes 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.

Time frame:
Baseline, 3 6, 9 months
Reported as:
Mean · Total score
Diabetes Technology Questionnaire-Adolescents
Total scoreStandard CareContinuous Glucose SensorCGS + Behavior Therapy
Baseline96.50 ± 18.29101.73 ± 23.26105.16 ± 27.89
3-Months102.24 ± 24.4492.50 ± 20.28105.95 ± 27.7
6-Months109.32 ± 19.57107.51 ± 21.65113.19 ± 24.41
9-Months112.62 ± 23.69103.00 ± 21.95103.93 ± 27.47
Statistical analysis
  • Standard Care vs Continuous Glucose Sensor · Generalized Estimating Equation · p = 0.03 · Mean difference (net): -10.05 · 95% CI -19.30 to -0.81
  • Standard Care vs CGS + Behavior Therapy · Generalized Estimating Equation · p = 0.88 · Mean difference (net): -0.82 · 95% CI -11.54 to 9.9
SecondaryDiabetes 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.

Time frame:
Baseline, 3, 6, 9 months
Reported as:
Mean · Total scores
Diabetes Technology Questionnaire-Parents' Total Scores on DTQ Current Items
Total scoresStandard CareContinuous Glucose SensorCGS + Behavior Therapy
Baseline90.06 ± 17.3991.68 ± 21.3486.87 ± 27.01
3-Months90.48 ± 25.0393.78 ± 21.3595.92 ± 26.76
6-Months93.21 ± 25.8294.70 ± 19.2596.27 ± 29.64
9-Months104.65 ± 21.6196.79 ± 18.1598.53 ± 23.31
Statistical analysis
  • Standard Care vs Continuous Glucose Sensor · Generalized Estimating Equation · p = 0.49 · Generalized estimating equation: -3.45 · 95% CI -13.21 to 6.32
  • Standard Care vs CGS + Behavior Therapy · Generalized Estimating Equation · p = 0.66 · Mean difference (net): 2.53
SecondaryBlood 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.

Time frame:
Baseline, 3, 6, 9 months
Reported as:
Mean · units on a scale
Blood Glucose Monitoring Communication Questionnaire-Adolescent
units on a scaleStandard CareContinuous Glucose SensorCGS + Behavior Therapy
Baseline14.24 ± 2.8414.46 ± 3.0414.29 ± 3.5
3-Months14.46 ± 2.8014.43 ± 3.7213.54 ± 4.21
6-Months13.76 ± 3.8814.57 ± 4.3613.16 ± 4.27
9-months14.25 ± 3.7614.03 ± 4.4914.47 ± 4.35
Statistical analysis
  • Standard Care vs Continuous Glucose Sensor · Generalized Estimating Equation · p = 0.64 · Mean difference (net): 0.40 · 95% CI -1.29 to 2.08
  • Standard Care vs CGS + Behavior Therapy · Generalized Estimating Equation · p = 0.65 · Mean difference (net): -0.41 · 95% CI -2.22 to 1.39
SecondaryBlood 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.

Time frame:
Baseline, 3, 6, 9 months
Reported as:
Mean · units on a scale
Blood Glucose Monitoring Communication Questionnaire-Parents
units on a scaleStandard CareContinuous Glucose SensorCGS + Behavior Therapy
Baseline14.08 ± 2.8314.59 ± 2.8714.29 ± 3.50
3-Months14.46 ± 3.0515.13 ± 3.2912.84 ± 3.36
6-Months15.16 ± 3.1415.41 ± 3.4312.72 ± 3.92
9-Months14.46 ± 3.3914.36 ± 1.9513.69 ± 3.57
Statistical analysis
  • Standard Care vs Continuous Glucose Sensor · Generalized Estimating Equation · p = 0.99 · Mean difference (net): 0.71 · 95% CI -123.56 to 124.97
  • Standard Care vs CGS + Behavior Therapy · Generalized Estimating Equation · p = 0.93 · Mean difference (net): -1.22 · 95% CI -28.26 to 25.83
SecondaryDiabetes 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.

Time frame:
Baseline, 3, 6, 9 months
Reported as:
Mean · units on a scale
Diabetes Family Conflict Scale-Adolescent
units on a scaleStandard CareContinuous Glucose SensorCGS + Behavior Therapy
Baseline27.72 ± 7.2527.54 ± 7.9227.59 ± 8.37
3-Months27.41 ± 7.2229.70 ± 9.5725.26 ± 8.16
6-Months27.07 ± 9.3128.73 ± 8.4824.35 ± 7.69
9-Months26.68 ± 9.3127.29 ± 6.5625.06 ± 9.09
Statistical analysis
  • Standard Care vs Continuous Glucose Sensor · Generalized Estimating Equation · p = 0.43 · Mean difference (net): 1.17 · 95% CI -1.70 to 4.04
  • Standard Care vs CGS + Behavior Therapy · Generalized Estimating Equation · p = 0.08 · Mean difference (net): -2.59 · 95% CI -5.50 to 0.32
SecondaryDiabetes 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.

Time frame:
Baseline, 3, 6, 9 months
Reported as:
Mean · units on a scale
Diabetes Family Conflict Scale-Parent
units on a scaleStandard CareContinuous Glucose SensorCGS + Behavior Therapy
Baseline28.76 ± 7.2727.76 ± 5.1227.75 ± 6.06
3-Months29.36 ± 8.4830.29 ± 7.8224.85 ± 5.13
6-Months30.62 ± 8.6829.05 ± 8.4424.85 ± 5.29
9-Months26.68 ± 5.3829.43 ± 6.8524.18 ± 3.19
Statistical analysis
  • Standard Care vs Continuous Glucose Sensor · Generalized Estimating Equation · p = 0.43 · Mean difference (net): 1.32 · 95% CI -1.94 to 4.56
  • Standard Care vs CGS + Behavior Therapy · Generalized Estimating Equation · p = .007 · Mean difference (net): -3.71 · 95% CI -6.38 to -1.04
SecondaryDiabetes 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.

Time frame:
Baserline, 3, 6, 9 months
Reported as:
Mean · units on a scale
Diabetes Family Responsibility Questionnaire-Adolescent
units on a scaleStandard CareContinuous Glucose SensorCGS + Behavior Therapy
Baseline31.53 ± 4.7431.15 ± 5.0431.38 ± 5.48
3-Months31.20 ± 5.3631.56 ± 4.1530.48 ± 5.02
6-Months29.85 ± 4.8829.96 ± 4.1528.71 ± 5.53
9-Months29.65 ± 4.7230.25 ± 4.1629.56 ± 5.21
Statistical analysis
  • Standard Care vs Continuous Glucose Sensor · Generalized Estimating Equation · p = 0.75 · Mean difference (net): 0.39 · 95% CI -2.02 to 2.79
  • Standard Care vs CGS + Behavior Therapy · Generalized Estimating Equation · p = 0.78 · Mean difference (net): -0.39 · 95% CI -3.09 to 2.32
SecondaryDiabetes 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.

Time frame:
Baseline, 3, 6, 9 months
Reported as:
Mean · units on a scale
Diabetes Family Responsibility Questionnaire-Parent
units on a scaleStandard CareContinuous Glucose SensorCGS + Behavior Therapy
Baseline34.44 ± 4.0535.19 ± 5.2233.97 ± 5.03
3-Months34.22 ± 5.3134.23 ± 6.3233.62 ± 4.24
6-Months32.50 ± 4.1934.35 ± 6.4732.30 ± 5.19
9-Months32.00 ± 4.0135.10 ± 5.1533.28 ± 5.16
Statistical analysis
  • Standard Care vs Continuous Glucose Sensor · Generalized Estimating Equation · p = 0.58 · Mean difference (net): 0.72 · 95% CI -1.86 to 3.29
  • Standard Care vs CGS + Behavior Therapy · Generalized Estimating Equation · p = 0.41 · Mean difference (net): -0.93 · 95% CI -3.17 to 1.3
SecondaryDiabetes Self Management Profile-Adolescent

Adolescent self-report of diabetes management behaviors. Score range 0-86. Higher scores indicate more meticulous diabetes treatment adherence.

Time frame:
Baseline, 3, 6, 9 months
Reported as:
Mean · units on a scale
Diabetes Self Management Profile-Adolescent
units on a scaleStandard CareContinuous Glucose SensorCGS + Behavior Therapy
Baseline57.05 ± 14.7160.25 ± 13.6859.38 ± 12.79
3-Months56.82 ± 13.8858.73 ± 14.1957.79 ± 13.47
6-Months59.36 ± 14.0361.14 ± 13.2259.07 ± 13.29
9-Months55.43 ± 14.4958.74 ± 13.7458.13 ± 14.17
Statistical analysis
  • Standard Care vs Continuous Glucose Sensor · Generalized Estimating Equation · p = 0.46 · Mean difference (net): 1.95 · 95% CI -3.26 to 7.15
  • Standard Care vs CGS + Behavior Therapy · Generalized Estimating Equation · p = 0.24 · Mean difference (net): -3.01 · 95% CI -7.99 to 1.96
SecondaryDiabetes 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.

Time frame:
Baseline, 3, 6, 9 months
Reported as:
Mean · units on a scale
Diabetes Self Management Profile-Parent
units on a scaleStandard CareContinuous Glucose SensorCGS + Behavior Therapy
Baseline52.76 ± 13.8155.45 ± 14.0655.94 ± 13.37
3-Months54.15 ± 13.4958.18 ± 14.5159.07 ± 12.84
6-Months51.93 ± 14.1759.26 ± 14.3760.19 ± 14.28
9-Months54.38 ± 13.6557.16 ± 13.5858.73 ± 14.11
Statistical analysis
  • Standard Care vs Continuous Glucose Sensor · Generalized Estimating Equation · p = 0.93 · Mean difference (net): 0.31 · 95% CI -6.33 to 6.91
  • Standard Care vs CGS + Behavior Therapy · Generalized Estimating Equation · p = 0.45 · Mean difference (net): -2.21 · 95% CI -8.01 to 3.57
SecondaryHypoglycemia 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

Time frame:
Baseline, 3, 6, 9 months
Reported as:
Mean · units on a scale
Hypoglycemia Fear Survey-Adolescent
units on a scaleStandard CareContinuous Glucose SensorCGS + Behavior Therapy
Baseline36.94 ± 11.6935.8 ± 12.4635.39 ± 12.55
3-Months35.95 ± 12.8637.15 ± 15.3431.00 ± 12.79
6-Months34.01 ± 12.9835.30 ± 11.5532.19 ± 16.12
9-Months27.91 ± 9.3138.00 ± 15.3835.24 ± 14.52
Statistical analysis
  • Standard Care vs Continuous Glucose Sensor · Generalized Estimating Equestion · p = 0.81 · Mean difference (net): -0.77 · 95% CI -7.15 to 5.62
  • Standard Care vs CGS + Behavior Therapy · Generalized Estimating Equation · p = 0.72 · Mean difference (net): 0.99 · 95% CI -4.11 to 6.08
SecondaryHypoglycemia 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.

Time frame:
Baseline, 3, 6, 9 months
Reported as:
Mean · units on a scale
Hypoglycemia Fear Survey-Parent
units on a scaleStandard CareContinuous Glucose SensorCGS + Behavior Therapy
Baseline43.31 ± 15.243.5 ± 11.5244.09 ± 13.85
3-Months40.07 ± 12.0041.56 ± 10.7239.79 ± 9.49
6-Months45.59 ± 12.7043.14 ± 9.4941.76 ± 16.71
9-Months38.48 ± 11.6239.87 ± 7.4840.67 ± 11.24
Statistical analysis
  • Standard Care vs Continuous Glucose Sensor · Generalized Estimating Equation · p = 0.71 · Mean difference (net): 0.99 · 95% CI -4.11 to 6.08
  • Standard Care vs CGS + Behavior Therapy · Generalized Estimating Equation · p = 0.68 · Mean difference (net): -1.16 · 95% CI -6.74 to 4.43

Adverse events

Collected over 9 months for each participant. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Standard Care0/38 (0%)0/38 (0%)0/38 (0%)
Continuous Glucose Sensor0/39 (0%)0/39 (0%)0/39 (0%)
CGS + Behavior Therapy0/35 (0%)0/35 (0%)0/35 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Standard CareContinuous Glucose SensorCGS + Behavior TherapyTotal
Mean13.61 ± 1.7613.62 ± 1.8213.46 ± 1.9813.56 ± 1.83
Sex: Female, Male
Sex: Female, Male(Participants)Standard CareContinuous Glucose SensorCGS + Behavior TherapyTotal
Female19192361
Male19201251
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Standard CareContinuous Glucose SensorCGS + Behavior TherapyTotal
Hispanic or Latino34512
Not Hispanic or Latino34343098
Unknown or Not Reported1102
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Standard CareContinuous Glucose SensorCGS + Behavior TherapyTotal
American Indian or Alaska Native0101
Asian1001
Native Hawaiian or Other Pacific Islander0000
Black or African American3339
White32322892
More than one race0000
Unknown or Not Reported2349
Region of Enrollment
Region of Enrollment(Participants)Standard CareContinuous Glucose SensorCGS + Behavior TherapyTotal
United States383935112
Glycated Hemoglobin Level (%)
Glycated Hemoglobin Level (%)(Percentage of hemoglobin)Standard CareContinuous Glucose SensorCGS + Behavior TherapyTotal
Mean8.84 ± 0.959.03 ± 1.079.24 ± 0.839.03 ± 0.96
08

Study locations

1 site
  • Nemours Children's Clinic
    Jacksonville, Florida 32207, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 22, 2018
  • Informed consent form · Nov 26, 2012

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00945659
Lead sponsor
Nemours Children's Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Timothy Wysocki (Principal Research Scientist and Center Director, Nemours Children's Clinic) — Principal investigator
First posted
Jul 24, 2009
Start date
Aug 2009
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Results posted
Sep 10, 2018
Last update
Sep 10, 2018

Study contacts

Tim Wysocki, Ph.D.
principal investigator · Nemours Children's Clinic Jacksonville

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Other studies from this sponsor

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