Type 1 Diabetes Mellitus
Conditions
Keywords
type 1 diabetes mellitus, adolescence, adherence, insulin pump, continuous subcutaneous insulin infusion, continuous glucose monitor, shared medical decision making
Brief summary
This work is testing a shared medical decision making intervention for adolescents with type 1 diabetes and their parents who are candidates for adding either an insulin pump or continuous glucose monitor to their treatment plan. The first half of the work consisted of the stakeholder driven design, construction and refinement of web-delivered multimedia decision aids for each of these decisions. The randomized controlled trial of that intervention began enroling participants in February 2015. A sample of 166 eligible adolescents who receive care at an operating entity of the Nemours Children's Health System will be enrolled and randomized to either Usual Clinical Practice alone or augmented by the Shared Medical Decision Making intervention. Primary outcomes include measures of engagement with the pertinent technology if it is chosen and measures of decision quality; Secondary outcomes include indices of metabolic control, quality of life and parent-adolescent relationships around diabetes management.
Detailed description
Abstract (modified after achievement of Aims 1 and 2): Treatment adherence in type 1 diabetes (T1D) tends to decline among adolescents, increasing risks of acute and chronic complications, excess health care use, poorer quality of life, and T1D-related family conflict. Poor adherence is associated with psychiatric and family dysfunction and often persists into early adulthood. Therapeutic advances such as continuous subcutaneous insulin infusion (CSII or insulin pump) and continuous glucose monitoring (CGM) could improve metabolic control and quality of life. But, teens often do not benefit fully from such advances. Many studies of adults show that patient-centered communication styles predict more favorable clinical outcomes. Shared medical decision making (SMDM) interventions have improved outcomes among adults with diabetes and other conditions. Research in pediatrics has also shown that patient-centered and family-centered communication styles predict favorable outcomes, but most of this research is in primary care and has not studied youth with chronic conditions. Since there have been no controlled trials of SMDM with chronically ill youths, we propose a randomized controlled trial of an SMDM intervention compared with Usual Clinical Practice (UCP). Qualitative interviews of youths and parents who have previously faced these decisions and reliance on expert consultants, pediatric endocrinologists and diabetes educators have preceded this trial and provided valued input for refining the planned intervention and adapting the structured SMDM format for pediatrics. Now, we will recruit and randomize 166 11-\<17 year old youth with T1D who are candidates for CSII or CGM (and a parent/caregiver) at all Nemours sites. The SMDM intervention will be delivered via a web-based platform, facilitated by Diabetes Educators (DEs) at each site in a standardized, yet individually tailored format. SMDM will employ multimedia decision aids prepared with the award-winning Nemours Center for Children's Health Media and the e-city interactive web design firm in Philadelphia in accord with pertinent international standards. SMDM will also include individualized assistance from the DE in assuring that each youth's and parent's preferences, values and cultural beliefs are carefully addressed and communicated to the attending endocrinologist. After a baseline evaluation and randomization to SMDM or UCP, effects on the primary outcome (treatment adherence; device utilization) and secondary outcomes (glycemic control, treatment alliance, decision conflict and regret, treatment satisfaction, diabetes-related distress and self-efficacy) will be measured over 1 year. Mixed effects modeling will be the primary analytic technique for evaluating effects on primary/secondary outcomes, examining selected variables as moderators and mediators of treatment effects, and assessing whether such effects are comparable for the two medical decisions of interest. The results will verify whether SMDM in this context enhances treatment adherence, device use and parent/patient-reported outcomes in youth with T1D.
Interventions
BEHAVIORALUsual Clinical Practice
Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.
BEHAVIORALShared Medical Decision Making
Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.
Sponsors
Patient-Centered Outcomes Research Institute
Nemours Children's Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
2 group (Usual Clinical Practice or Shared Medical Decision Making X 5 time points (0, 3, 6, 9 and 12 months) repeated measures randomized treatments design.
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes for 1 year or more * At least 2 diabetes clinic visits at the enrolling site in the prior year * Considered by treating endocrinologist to be a candidate for insulin pump or continuous glucose monitor * Intent to continue care at Nemours for 1 year * Internet access at home, school, work or relative's home
Exclusion criteria
* Open case with child protection agency * Unable to read and speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Measure was collected at each study visit after the participant actually obtained a CGM or Insulin Pump | Adolescent and Parent report regarding degree to which use of the device of interest has become an integral part of the adolescent's daily diabetes self management. Scores may range from 10 to 50, with higher scores reflecting more frequent and meticulous use of the diabetes device of interest. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Hemoglobin (Hemoglobin A1C) | Every 3 months for for 1 year | Glycated hemoglobin (Hemoglobin A1C) expressed as the percentage of hemoglobin molecules that are bound to glucose. Normal range is approximately 4.5% to 6.5%, Higher values indicate a higher blood glucose concentration over the preceding 2-3 months. |
| Decision Regret Scale | Obtained at Visits 3 and 5 only | Questionnaire measuring decision making regret. Reflecting on a specific decision (accept or decline opportunity to use CGM or insulin pump), higher score reflect a greater degree of regret regarding the decision that was made. Scores may range from 5 to 20. |
| Knowledge of Insulin Pump or Continuous Glucose Monitor | Baseline and 3 months later | Brief test of parent and adolescent knowledge about the pertinent device and its use. Higher scores reflect more precise knowledge about the diabetes device of interest. Scores may range from 1 to 5. |
| Diabetes Self Management Profile Self Report Form | Visits 1, 3 and 5 | Composite measure of diabetes treatment adherence consisting of combined scores based on reports of parents and adolescents. Higher scores reflect more meticulous adherence to recommended diabetes self management behaviors. Scores may range from 0 to 86. |
| SURE Test | Measured at Follow-up Visits 3 and 5 only | 4-item questionnaire that measures patients' confidence in a health care decision that has been made. Scores may range from 0-4 with higher scores reflecting greater confidence in the decision made regarding insulin pump or CGM. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from 2015-2017 at all locations of Nemours Children's Health System (Wilmington, DE, Philadelphia, PA and Jacksonville, Orlando and Pensacola, FL. In 2017, the Barbara Davis Center for Childhood Diabetes in Denver was added as a performance site.
Pre-assignment details
Of the 153 adolescent-parent dyads who provided consent/assent, 20 dyads did not complete all required baseline measures and were not randomized. 133 dyads were randomized to Usual Clinical Practice or Shared Decision Making.
Participants by arm
| Arm | Count |
|---|---|
| Usual Clinical Practice (UCP) UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring received by similar patients who were not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient.
Usual Clinical Practice: Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site. | 67 |
| Shared Medical Decision Making (SMDM) Participants randomized to SMDM received all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump or CGM). Adolescents and parents received password-protected, secure access to the decision for their use until a decision was reached. The platform then generated a summary report that the adolescent and parent could discuss with a diabetes nurse and then a visit with the treating endocrinologist was scheduled to conclude the SMDM intervention for that adolescent and parent.
Shared Medical Decision Making: Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen. | 66 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | 13SDM dyads did not access Decision Aids | 0 | 13 |
| Overall Study | Lost to Follow-up | 5 | 0 |
Baseline characteristics
| Characteristic | Usual Clinical Practice (UCP) | Shared Medical Decision Making (SMDM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 67 Participants | 66 Participants | 133 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 13.9 years STANDARD_DEVIATION 2 | 13.5 years STANDARD_DEVIATION 2 | 13.7 years STANDARD_DEVIATION 1.9 |
| CGM/Insulin Pump Knowledge Test | 36.7 units on a scale STANDARD_DEVIATION 5.34 | 41.29 units on a scale STANDARD_DEVIATION 5.09 | 39.1 units on a scale STANDARD_DEVIATION 5.23 |
| Diabetes Numeracy Test | 10.3 units on a scale STANDARD_DEVIATION 2.48 | 11.0 units on a scale STANDARD_DEVIATION 3.41 | 10.7 units on a scale STANDARD_DEVIATION 2.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 5 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 61 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin A1C | 8.61 percent STANDARD_DEVIATION 1.29 | 8.53 percent STANDARD_DEVIATION 1.49 | 8.58 percent STANDARD_DEVIATION 1.41 |
| Hollingshead Four Factor Index of Social Status | 45.7 units on a scale STANDARD_DEVIATION 14.2 | 43.9 units on a scale STANDARD_DEVIATION 13.1 | 44.9 units on a scale STANDARD_DEVIATION 13.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) White | 49 Participants | 55 Participants | 104 Participants |
| Rapid Estimate of Adult/Adolescent Literacy in Medicine | 62.9 units on a scale STANDARD_DEVIATION 3.44 | 61.2 units on a scale STANDARD_DEVIATION 4.93 | 62.1 units on a scale STANDARD_DEVIATION 3.89 |
| Region of Enrollment United States | 67 participants | 66 participants | 133 participants |
| Sex: Female, Male Female | 31 Participants | 34 Participants | 65 Participants |
| Sex: Female, Male Male | 36 Participants | 32 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 66 |
| other Total, other adverse events | 0 / 67 | 0 / 66 |
| serious Total, serious adverse events | 0 / 67 | 0 / 67 |
Outcome results
Primary
Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile
Adolescent and Parent report regarding degree to which use of the device of interest has become an integral part of the adolescent's daily diabetes self management. Scores may range from 10 to 50, with higher scores reflecting more frequent and meticulous use of the diabetes device of interest.
Time frame: Measure was collected at each study visit after the participant actually obtained a CGM or Insulin Pump
Population: The population of interest consists of adolescents with type 1 diabetes and their parents who are considered to be candidates for adoption of either the insulin pump or continuous glucose monitor as a component of their diabetes management regimens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Clinical Practice (UCP) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit 2-Adolescents | 32.5 score on a scale | Standard Deviation 4.3 |
| Usual Clinical Practice (UCP) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit 2-Parents | 40.1 score on a scale | Standard Deviation 3.7 |
| Usual Clinical Practice (UCP) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit 3-Adolescents | 33.8 score on a scale | Standard Deviation 4.7 |
| Usual Clinical Practice (UCP) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit Visit 3-Parents | 30.2 score on a scale | Standard Deviation 3.1 |
| Usual Clinical Practice (UCP) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit 4-Adolescents | 33.7 score on a scale | Standard Deviation 5.8 |
| Usual Clinical Practice (UCP) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit 4-Parents | 34.6 score on a scale | Standard Deviation 4.3 |
| Usual Clinical Practice (UCP) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit 5-Adolescents | 33.3 score on a scale | Standard Deviation 4.9 |
| Usual Clinical Practice (UCP) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit 5-Parents | 34.4 score on a scale | Standard Deviation 5.6 |
| Shared Medical Decision Making (SMDM) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit 5-Parents | 33.3 score on a scale | Standard Deviation 5.1 |
| Shared Medical Decision Making (SMDM) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit 2-Adolescents | 34.2 score on a scale | Standard Deviation 3.9 |
| Shared Medical Decision Making (SMDM) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit 4-Adolescents | 33.5 score on a scale | Standard Deviation 4.8 |
| Shared Medical Decision Making (SMDM) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit 2-Parents | 35.7 score on a scale | Standard Deviation 5.1 |
| Shared Medical Decision Making (SMDM) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit 5-Adolescents | 30.1 score on a scale | Standard Deviation 4.7 |
| Shared Medical Decision Making (SMDM) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit 3-Adolescents | 33.7 score on a scale | Standard Deviation 3.7 |
| Shared Medical Decision Making (SMDM) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit 4-Parents | 32.1 score on a scale | Standard Deviation 4.3 |
| Shared Medical Decision Making (SMDM) | Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile | Visit Visit 3-Parents | 35.1 score on a scale | Standard Deviation 4.6 |
Comparison: Missing data treatment was done using multiple imputation methods when data were determined to be Missing Completely at Random or Missing at Random. Assumptions underlying each statistical test were evaluated before proceeding with specific analyses.p-value: <0.39Mixed Models Analysis
Secondary
Decision Regret Scale
Questionnaire measuring decision making regret. Reflecting on a specific decision (accept or decline opportunity to use CGM or insulin pump), higher score reflect a greater degree of regret regarding the decision that was made. Scores may range from 5 to 20.
Time frame: Obtained at Visits 3 and 5 only
Population: Adolescents with type 1 diabetes and their parents who are considered by their diabetes care providers to be candidates for incorporation of insulin pump or CGM into their treatment regimens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Clinical Practice (UCP) | Decision Regret Scale | Visit 3 | 9.14 score on a scale | Standard Deviation 3.7 |
| Usual Clinical Practice (UCP) | Decision Regret Scale | Visit 5 | 8.69 score on a scale | Standard Deviation 3.11 |
| Shared Medical Decision Making (SMDM) | Decision Regret Scale | Visit 3 | 9.85 score on a scale | Standard Deviation 4.07 |
| Shared Medical Decision Making (SMDM) | Decision Regret Scale | Visit 5 | 8.53 score on a scale | Standard Deviation 3.08 |
Comparison: See description of analysis below.p-value: >0.05Mixed Models Analysis
Secondary
Diabetes Self Management Profile Self Report Form
Composite measure of diabetes treatment adherence consisting of combined scores based on reports of parents and adolescents. Higher scores reflect more meticulous adherence to recommended diabetes self management behaviors. Scores may range from 0 to 86.
Time frame: Visits 1, 3 and 5
Population: Adolescents with T1D and parents considering adoption of CSII or CGM.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Clinical Practice (UCP) | Diabetes Self Management Profile Self Report Form | Visit 1 | 55.03 score on a scale | Standard Deviation 10.66 |
| Usual Clinical Practice (UCP) | Diabetes Self Management Profile Self Report Form | Visit 3 | 55.91 score on a scale | Standard Deviation 10.83 |
| Usual Clinical Practice (UCP) | Diabetes Self Management Profile Self Report Form | Visit 5 | 56.08 score on a scale | Standard Deviation 11.98 |
| Shared Medical Decision Making (SMDM) | Diabetes Self Management Profile Self Report Form | Visit 1 | 56.19 score on a scale | Standard Deviation 10.03 |
| Shared Medical Decision Making (SMDM) | Diabetes Self Management Profile Self Report Form | Visit 3 | 56.25 score on a scale | Standard Deviation 11.17 |
| Shared Medical Decision Making (SMDM) | Diabetes Self Management Profile Self Report Form | Visit 5 | 54.14 score on a scale | Standard Deviation 12.27 |
Secondary
Glycated Hemoglobin (Hemoglobin A1C)
Glycated hemoglobin (Hemoglobin A1C) expressed as the percentage of hemoglobin molecules that are bound to glucose. Normal range is approximately 4.5% to 6.5%, Higher values indicate a higher blood glucose concentration over the preceding 2-3 months.
Time frame: Every 3 months for for 1 year
Population: Adolescents with type 1 diabetes and their parents who are considered by their attending diabetes care providers to be candidates for incorporation of the insulin pump or continuous glucose monitoring into their treatment regimens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Clinical Practice (UCP) | Glycated Hemoglobin (Hemoglobin A1C) | Visit 3 | 8.80 percentage (HbA1c) | Standard Deviation 1.48 |
| Usual Clinical Practice (UCP) | Glycated Hemoglobin (Hemoglobin A1C) | Visit 1 | 8.61 percentage (HbA1c) | Standard Deviation 1.29 |
| Usual Clinical Practice (UCP) | Glycated Hemoglobin (Hemoglobin A1C) | Visit 4 | 9.24 percentage (HbA1c) | Standard Deviation 2.03 |
| Usual Clinical Practice (UCP) | Glycated Hemoglobin (Hemoglobin A1C) | Visit 5 | 8.69 percentage (HbA1c) | Standard Deviation 1.43 |
| Usual Clinical Practice (UCP) | Glycated Hemoglobin (Hemoglobin A1C) | Visit 2 | 8.54 percentage (HbA1c) | Standard Deviation 1.3 |
| Shared Medical Decision Making (SMDM) | Glycated Hemoglobin (Hemoglobin A1C) | Visit 5 | 8.83 percentage (HbA1c) | Standard Deviation 1.95 |
| Shared Medical Decision Making (SMDM) | Glycated Hemoglobin (Hemoglobin A1C) | Visit 1 | 8.53 percentage (HbA1c) | Standard Deviation 1.49 |
| Shared Medical Decision Making (SMDM) | Glycated Hemoglobin (Hemoglobin A1C) | Visit 3 | 8.55 percentage (HbA1c) | Standard Deviation 1.48 |
| Shared Medical Decision Making (SMDM) | Glycated Hemoglobin (Hemoglobin A1C) | Visit 4 | 8.59 percentage (HbA1c) | Standard Deviation 1.29 |
| Shared Medical Decision Making (SMDM) | Glycated Hemoglobin (Hemoglobin A1C) | Visit 2 | 8.24 percentage (HbA1c) | Standard Deviation 1.25 |
p-value: >0.05Mixed Models Analysis
Secondary
Knowledge of Insulin Pump or Continuous Glucose Monitor
Brief test of parent and adolescent knowledge about the pertinent device and its use. Higher scores reflect more precise knowledge about the diabetes device of interest. Scores may range from 1 to 5.
Time frame: Baseline and 3 months later
Population: Adolescents with T1D and their parents considering adoption of CSII or CGM.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Clinical Practice (UCP) | Knowledge of Insulin Pump or Continuous Glucose Monitor | Visit 1 | 2.86 score on a scale | Standard Deviation 1.18 |
| Usual Clinical Practice (UCP) | Knowledge of Insulin Pump or Continuous Glucose Monitor | Visit 2 | 3.14 score on a scale | Standard Deviation 1.14 |
| Shared Medical Decision Making (SMDM) | Knowledge of Insulin Pump or Continuous Glucose Monitor | Visit 1 | 2.76 score on a scale | Standard Deviation 1.21 |
| Shared Medical Decision Making (SMDM) | Knowledge of Insulin Pump or Continuous Glucose Monitor | Visit 2 | 3.40 score on a scale | Standard Deviation 1.11 |
p-value: >0.05ANCOVA
Secondary
SURE Test
4-item questionnaire that measures patients' confidence in a health care decision that has been made. Scores may range from 0-4 with higher scores reflecting greater confidence in the decision made regarding insulin pump or CGM.
Time frame: Measured at Follow-up Visits 3 and 5 only
Population: Adolescents with T1D and parents considering adoption of CSII or CGM.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Clinical Practice (UCP) | SURE Test | Visit 3 | 3.43 score on a scale | Standard Deviation 0.74 |
| Usual Clinical Practice (UCP) | SURE Test | Visit 5 | 3.70 score on a scale | Standard Deviation 0.56 |
| Shared Medical Decision Making (SMDM) | SURE Test | Visit 3 | 3.74 score on a scale | Standard Deviation 0.5 |
| Shared Medical Decision Making (SMDM) | SURE Test | Visit 5 | 3.73 score on a scale | Standard Deviation 0.46 |
p-value: >0.05ANOVA