Type 1 Diabetes Clinical Trial
— ROUTE-T1DOfficial title:
Optimizing Technology Uptake and Use in Hard to Reach Adolescents With Type 1 Diabetes
Verified date | February 2024 |
Source | Children's National Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Consistent use of continuous glucose monitors (CGM) has the potential to improve glycemic control and related type 1 diabetes (T1D) health outcomes, however young adolescents with T1D are the least likely age group to begin and sustain use of CGM. The proposed study will conduct a feasibility trial of a behavioral intervention designed to optimize use of CGM in adolescents specifically targeting underrepresented populations in diabetes technology research.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | December 30, 2026 |
Est. primary completion date | July 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 15 Years |
Eligibility | Inclusion Criteria: - 10-15 years old - Type 1 diabetes - Type 1 diabetes diagnosis = 6 months \ - Starting a continuous glucose monitor for the first time or restarting after = 1 year Exclusion Criteria: - Younger than 10, older than 15 - Diagnosed less than 6 months - Already using CGM or has used within last year - Other major medical condition such as cancer, cystic fibrosis |
Country | Name | City | State |
---|---|---|---|
United States | Children's National Research Institute | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Children's National Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glycemic control | hemoglobin A1c (HbA1c) | Baseline | |
Primary | Glycemic control | hemoglobin A1c (HbA1c) | 3 months post randomization | |
Primary | Glycemic control | hemoglobin A1c (HbA1c) | 6 months post randomization | |
Primary | Glycemic control | hemoglobin A1c (HbA1c) | 12 months post randomization | |
Primary | glycemic variability | Using 14-30 days of CGM data | Baseline | |
Primary | glycemic variability | Using 14-30 days of CGM data | 3 months post randomization | |
Primary | glycemic variability | Using 14-30 days of CGM data | 6 months post randomization | |
Primary | glycemic variability | Using 14-30 days of CGM data | 12 months post randomization | |
Secondary | Family Conflict | The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict | Baseline | |
Secondary | Family Conflict | The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict | 3 months post randomization | |
Secondary | Family Conflict | The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict | 6 months post randomization | |
Secondary | Family Conflict | The Diabetes Family Conflict Scale-Revised Scored 19-57 where a higher score indicates higher family conflict | 12 months post randomization | |
Secondary | Diabetes Distress | Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress | Baseline | |
Secondary | Diabetes Distress | Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress | 3 months post randomization | |
Secondary | Diabetes Distress | Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress | 6 months post randomization | |
Secondary | Diabetes Distress | Problem Areas in Diabetes scales (PAID) Scored 14-84 where higher scores indicate higher distress | 12 months post randomization | |
Secondary | CGM benefits and burdens | Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM | Baseline | |
Secondary | CGM benefits and burdens | Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM | 3 months post randomization | |
Secondary | CGM benefits and burdens | Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM | 6 months post randomization | |
Secondary | CGM benefits and burdens | Continuous glucose monitoring (CGM) Burdens and Benefits as assessed by The BenCGM and BurCGM | 12 month post randomization | |
Secondary | CGM use | Indicators of CGM use, including mean days work per week, will be evaluated to measure sustained use of CGM. | Baseline | |
Secondary | CGM use | Indicators of CGM use, including mean days work per week, will be evaluated to measure sustained use of CGM. | 3 months post randomization | |
Secondary | CGM use | Indicators of CGM use, including mean days work per week, will be evaluated to measure sustained use of CGM. | 6 months post randomization | |
Secondary | CGM use | Indicators of CGM use, including mean days work per week, will be evaluated to measure sustained use of CGM. | 12 months post randomization | |
Secondary | Diabetes self-management | The Diabetes Management Questionnaire (DMQ)-a self- and parent-report measure assessing the frequency of engagement in diabetes care behaviors (e.g. BG monitoring, adjusting behavior to specific situations) over the past month.
Scored 0-100 with higher scores indicating higher adherence to diabetes management |
Baseline | |
Secondary | Diabetes self-management | The Diabetes Management Questionnaire (DMQ)-a self- and parent-report measure assessing the frequency of engagement in diabetes care behaviors (e.g. BG monitoring, adjusting behavior to specific situations) over the past month.
Scored 0-100 with higher scores indicating higher adherence to diabetes management |
3 months post randomization | |
Secondary | Diabetes self-management | The Diabetes Management Questionnaire (DMQ)-a self- and parent-report measure assessing the frequency of engagement in diabetes care behaviors (e.g. BG monitoring, adjusting behavior to specific situations) over the past month.
Scored 0-100 with higher scores indicating higher adherence to diabetes management |
6 months post randomization | |
Secondary | Diabetes self-management | The Diabetes Management Questionnaire (DMQ)-a self- and parent-report measure assessing the frequency of engagement in diabetes care behaviors (e.g. BG monitoring, adjusting behavior to specific situations) over the past month.
Scored 0-100 with higher scores indicating higher adherence to diabetes management |
12 months post randomization |
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