Trial Outcomes & Findings for Shared Medical Decision Making in Pediatric Diabetes (NCT NCT02496156)

Last Updated: 2024-02-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

153 participants

Primary outcome timeframe

Measure was collected at each study visit after the participant actually obtained a CGM or Insulin Pump

Results posted on

2024-02-01

Participant Flow

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.

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.

Unit of analysis: Adolescent-Parent dyads

Participant milestones

Participant milestones
Measure	Usual Clinical Practice (UCP) UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is received by similar patients who are 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.	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, CGM or both). Adolescents and parents received password-protected, secure access to the decision for their use until a decision was reached. The platform 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.
Overall Study STARTED	67 67	66 66
Overall Study COMPLETED	62 62	53 53
Overall Study NOT COMPLETED	5 5	13 13

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Clinical Practice (UCP) UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is received by similar patients who are 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.	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, CGM or both). Adolescents and parents received password-protected, secure access to the decision for their use until a decision was reached. The platform 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.
Overall Study Lost to Follow-up	5	0
Overall Study 13SDM dyads did not access Decision Aids	0	13

Baseline Characteristics

Shared Medical Decision Making in Pediatric Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Clinical Practice (UCP) n=67 Participants 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.	Shared Medical Decision Making (SMDM) n=66 Participants 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.	Total n=133 Participants Total of all reporting groups
Age, Categorical <=18 years	67 Participants n=5 Participants	66 Participants n=7 Participants	133 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	13.9 years STANDARD_DEVIATION 2.0 • n=5 Participants	13.5 years STANDARD_DEVIATION 2.0 • n=7 Participants	13.7 years STANDARD_DEVIATION 1.9 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	34 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	32 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	61 Participants n=7 Participants	115 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	55 Participants n=7 Participants	104 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	67 participants n=5 Participants	66 participants n=7 Participants	133 participants n=5 Participants
Hollingshead Four Factor Index of Social Status	45.7 units on a scale STANDARD_DEVIATION 14.2 • n=5 Participants	43.9 units on a scale STANDARD_DEVIATION 13.1 • n=7 Participants	44.9 units on a scale STANDARD_DEVIATION 13.8 • n=5 Participants
Rapid Estimate of Adult/Adolescent Literacy in Medicine	62.9 units on a scale STANDARD_DEVIATION 3.44 • n=5 Participants	61.2 units on a scale STANDARD_DEVIATION 4.93 • n=7 Participants	62.1 units on a scale STANDARD_DEVIATION 3.89 • n=5 Participants
Diabetes Numeracy Test	10.3 units on a scale STANDARD_DEVIATION 2.48 • n=5 Participants	11.0 units on a scale STANDARD_DEVIATION 3.41 • n=7 Participants	10.7 units on a scale STANDARD_DEVIATION 2.99 • n=5 Participants
CGM/Insulin Pump Knowledge Test	36.7 units on a scale STANDARD_DEVIATION 5.34 • n=5 Participants	41.29 units on a scale STANDARD_DEVIATION 5.09 • n=7 Participants	39.1 units on a scale STANDARD_DEVIATION 5.23 • n=5 Participants
Hemoglobin A1C	8.61 percent STANDARD_DEVIATION 1.29 • n=5 Participants	8.53 percent STANDARD_DEVIATION 1.49 • n=7 Participants	8.58 percent STANDARD_DEVIATION 1.41 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Clinical Practice (UCP) n=62 Participants UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is 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.	Shared Medical Decision Making (SMDM) n=53 Participants 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 is 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.
Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile Visit 2-Adolescents	32.5 score on a scale Standard Deviation 4.3	34.2 score on a scale Standard Deviation 3.9
Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile Visit 2-Parents	40.1 score on a scale Standard Deviation 3.7	35.7 score on a scale Standard Deviation 5.1
Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile Visit 3-Adolescents	33.8 score on a scale Standard Deviation 4.7	33.7 score on a scale Standard Deviation 3.7
Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile Visit Visit 3-Parents	30.2 score on a scale Standard Deviation 3.1	35.1 score on a scale Standard Deviation 4.6
Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile Visit 4-Adolescents	33.7 score on a scale Standard Deviation 5.8	33.5 score on a scale Standard Deviation 4.8
Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile Visit 4-Parents	34.6 score on a scale Standard Deviation 4.3	32.1 score on a scale Standard Deviation 4.3
Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile Visit 5-Adolescents	33.3 score on a scale Standard Deviation 4.9	30.1 score on a scale Standard Deviation 4.7
Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile Visit 5-Parents	34.4 score on a scale Standard Deviation 5.6	33.3 score on a scale Standard Deviation 5.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual Clinical Practice (UCP) n=62 Participants UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is 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.	Shared Medical Decision Making (SMDM) n=53 Participants 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 is 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.
Glycated Hemoglobin (Hemoglobin A1C) Visit 1	8.61 percentage (HbA1c) Standard Deviation 1.29	8.53 percentage (HbA1c) Standard Deviation 1.49
Glycated Hemoglobin (Hemoglobin A1C) Visit 2	8.54 percentage (HbA1c) Standard Deviation 1.30	8.24 percentage (HbA1c) Standard Deviation 1.25
Glycated Hemoglobin (Hemoglobin A1C) Visit 3	8.80 percentage (HbA1c) Standard Deviation 1.48	8.55 percentage (HbA1c) Standard Deviation 1.48
Glycated Hemoglobin (Hemoglobin A1C) Visit 4	9.24 percentage (HbA1c) Standard Deviation 2.03	8.59 percentage (HbA1c) Standard Deviation 1.29
Glycated Hemoglobin (Hemoglobin A1C) Visit 5	8.69 percentage (HbA1c) Standard Deviation 1.43	8.83 percentage (HbA1c) Standard Deviation 1.95

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual Clinical Practice (UCP) n=62 Participants UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is 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.	Shared Medical Decision Making (SMDM) n=53 Participants 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 is 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.
Decision Regret Scale Visit 3	9.14 score on a scale Standard Deviation 3.70	9.85 score on a scale Standard Deviation 4.07
Decision Regret Scale Visit 5	8.69 score on a scale Standard Deviation 3.11	8.53 score on a scale Standard Deviation 3.08

SECONDARY outcome

Timeframe: Baseline and 3 months later

Population: Adolescents with T1D and their parents considering adoption of CSII or CGM.

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.

Outcome measures

Outcome measures
Measure	Usual Clinical Practice (UCP) n=62 Participants UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is 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.	Shared Medical Decision Making (SMDM) n=53 Participants 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 is 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.
Knowledge of Insulin Pump or Continuous Glucose Monitor Visit 1	2.86 score on a scale Standard Deviation 1.18	2.76 score on a scale Standard Deviation 1.21
Knowledge of Insulin Pump or Continuous Glucose Monitor Visit 2	3.14 score on a scale Standard Deviation 1.14	3.40 score on a scale Standard Deviation 1.11

SECONDARY outcome

Timeframe: Visits 1, 3 and 5

Population: Adolescents with T1D and parents considering adoption of CSII or CGM.

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.

Outcome measures

Outcome measures
Measure	Usual Clinical Practice (UCP) n=62 Participants UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is 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.	Shared Medical Decision Making (SMDM) n=53 Participants 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 is 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.
Diabetes Self Management Profile Self Report Form Visit 1	55.03 score on a scale Standard Deviation 10.66	56.19 score on a scale Standard Deviation 10.03
Diabetes Self Management Profile Self Report Form Visit 3	55.91 score on a scale Standard Deviation 10.83	56.25 score on a scale Standard Deviation 11.17
Diabetes Self Management Profile Self Report Form Visit 5	56.08 score on a scale Standard Deviation 11.98	54.14 score on a scale Standard Deviation 12.27

SECONDARY outcome

Timeframe: Measured at Follow-up Visits 3 and 5 only

Population: Adolescents with T1D and parents considering adoption of CSII or CGM.

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.

Outcome measures

Outcome measures
Measure	Usual Clinical Practice (UCP) n=62 Participants UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is 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.	Shared Medical Decision Making (SMDM) n=53 Participants 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 is 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.
SURE Test Visit 3	3.43 score on a scale Standard Deviation 0.74	3.74 score on a scale Standard Deviation 0.50
SURE Test Visit 5	3.70 score on a scale Standard Deviation 0.56	3.73 score on a scale Standard Deviation 0.46

Adverse Events

Usual Clinical Practice (UCP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Shared Medical Decision Making (SMDM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vicky Funanage, PhD, Operational Vice President for Research

Nemours Children's Health System

Phone: 302-651-6819

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place