Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK129479 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stanford University | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
In this 2-year randomized clinical trial, we will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress and improve glycemic outcomes in adolescents and young adults, aged 14-25 years, with T1D in order to optimize their short-term and long-term health.
In this study, we will recruit 180 adolescents and young adults (ages 14-25) with type 1 diabetes for at least 1 year and suboptimal diabetes control (A1c 7-13%) to participate in a 2-year randomized clinical trial aimed at reducing diabetes distress and improving glycemic outcomes. Adolescents and young adults with type 1 diabetes represent a population that often has uncontrolled diabetes with elevated A1c levels and experiences diabetes distress, making such patients ideal for this study. Participants will be randomly assigned to one of two groups (control or intervention). The intervention group will participate in monthly intervention sessions with a research assistant during the first year of the study. Four sessions will focus on improving glycemic outcomes and 8 sessions will focus on reducing diabetes distress. The sessions will be conducted face-to-face or remotely. To ensure adequate recruitment and retention, the control group will participate in the intervention sessions during the second year of the study. Participants in both groups will use continuous glucose monitoring (CGM), with CGM data downloaded every 3 months. Participants in both groups will complete surveys and have A1c measured every 6 months. We will compare the two groups on percent time in target glucose range (70-180 mg/dL), A1c, and diabetes distress from baseline to 1 year. We hypothesize that the intervention group will have an improvement in percent time in range, A1c, and diabetes distress, compared with the control group.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The Intervention Group will receive the monthly intervention sessions during the first year of the study. |
|
| Control Group | No Intervention | The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychoeducation to reduce diabetes distress and improve glycemic outcomes | Behavioral | The intervention includes two types of sessions - those targeting an improvement in glycemic outcomes and those targeting a reduction in diabetes distress. Evidence indicates that psychoeducation and support are needed to improve self-care behaviors and optimize use of advanced diabetes technologies, which, in turn, can help improve diabetes control while also reducing diabetes distress. Participants will receive 4 one-on-one glycemic sessions and 8 one-on-one distress sessions, each lasting ~30 minutes. Sessions will be conducted in-person or remotely. The virtual sessions are intended to provide the extra psychoeducation and support needed for this high risk group without increasing the burden associated with frequent face-to-face sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range (TIR) | CGM data will be downloaded every 3 months to assess percent time in range (TIR) (70-180 mg/dL). The primary outcome will be change in TIR from 0 to 12 months for intervention group vs. control group. | 0, 3, 6, 9, 12, 15, 18, 21, and 24 months (months 0-12 reported for primary outcome analysis) |
| Measure | Description | Time Frame |
|---|---|---|
| A1c | A1c will be assessed every 6 months. Blood samples will be collected locally using uniform procedures and sent to the central laboratory at the University of Minnesota for analysis. Change in A1c from 0 to 12 months will be compared within and between the intervention group and control group. | 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lori M Laffel, MD, MPH | Joslin Diabetes Center | Principal Investigator |
| Korey K Hood, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States | ||
| Joslin Diabetes Center |
If we are able to remove all HIPAA-defined identifiers from the final data set to eliminate the possibility of deductive disclosure of participants with unusual characteristics, the investigators will make the final data set available to interested researchers according to the NIH Data Sharing Policy and the criteria below.
Not provided
After all of the investigators' analyses, presentations, and publications of study findings are complete
If it is determined that data can be shared, data will be made available upon request to qualified persons only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are complete.
Not provided
26 participants consented but were not randomized (18 did not complete baseline data, 5 had an ineligible central lab A1c, 2 withdrew, and 1 was a sibling of a randomized participant)
217 participants provided informed consent and 191 were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | The Intervention Group will receive the monthly intervention sessions during the first year of the study. |
| FG001 | Control Group | The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | The Intervention Group will receive the monthly intervention sessions during the first year of the study. |
| BG001 | Control Group | The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time in Range (TIR) | CGM data will be downloaded every 3 months to assess percent time in range (TIR) (70-180 mg/dL). The primary outcome will be change in TIR from 0 to 12 months for intervention group vs. control group. | Some participants did not have CGM data at some time points, and thus there are some missing data. | Posted | Mean | Standard Deviation | Percent of time | 0, 3, 6, 9, 12, 15, 18, 21, and 24 months (months 0-12 reported for primary outcome analysis) |
|
From enrollment until end of follow-up, up to 2 years
For this study involving a behavioral intervention delivered remotely, adverse events met the definition of an SAE, were unexpected, or were related/possibly related to the study. Note: One participant in the Intervention Group and one participant in the Control group experienced both a diabetes-related hospitalization and a non-diabetes-related hospitalization while receiving intervention sessions (Year 1 for Intervention Group, Year 2 for Control Group).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group - Year 1 - Intervention Sessions | The Intervention Group will receive the monthly intervention sessions during the first year of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization - Diabetes-related | Endocrine disorders | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori Laffel, MD, MPH | Joslin Diabetes Center | 6177322603 | 5 | lori.laffel@joslin.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2022 | Oct 7, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2023 | Nov 9, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Diabetes Distress | Diabetes distress will be assessed every 6 months using the validated Problem Areas in Diabetes - Pediatric survey (PAID-Peds). The PAID-Peds measures self-reported diabetes distress. The total score can range from 0 to 100, with higher scores indicating more diabetes distress. Change in diabetes distress from 0 to 12 months will be compared within and between the intervention group and control group. | 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis) |
| Attitudes Toward Diabetes Device Use | Attitudes toward diabetes device use will be assessed every 6 months using the validated Glucose Monitoring Satisfaction Survey for Type 1 Diabetes (GMSS-T1D) and the Diabetes Technology Attitudes Scale (DTAS). The GMSS-T1D measures satisfaction with glucose monitoring device (e.g., meter, continuous glucose monitoring system). The total score can range from 1 to 5 and was calculated by averaging all 15 survey items. A higher score indicates more satisfaction. The DTAS measures attitudes about diabetes devices and technology. The total score can range from 5 to 25 and was calculated by summing all 5 survey items. A higher score indicates more positive attitudes about diabetes devices and technology. Change in attitudes toward device use from 0 to 12 months will be compared within and between the intervention group and control group. | 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis) |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year).
|
|
|
| Secondary | A1c | A1c will be assessed every 6 months. Blood samples will be collected locally using uniform procedures and sent to the central laboratory at the University of Minnesota for analysis. Change in A1c from 0 to 12 months will be compared within and between the intervention group and control group. | Some participants did not complete the central lab A1c at some time points, and thus there are some missing data. | Posted | Mean | Standard Deviation | A1c % | 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis) |
|
|
|
|
| Secondary | Diabetes Distress | Diabetes distress will be assessed every 6 months using the validated Problem Areas in Diabetes - Pediatric survey (PAID-Peds). The PAID-Peds measures self-reported diabetes distress. The total score can range from 0 to 100, with higher scores indicating more diabetes distress. Change in diabetes distress from 0 to 12 months will be compared within and between the intervention group and control group. | Some participants did not complete surveys at some time points, and thus there are some missing data. | Posted | Mean | Standard Deviation | Score on a survey | 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis) |
|
|
|
|
| Secondary | Attitudes Toward Diabetes Device Use | Attitudes toward diabetes device use will be assessed every 6 months using the validated Glucose Monitoring Satisfaction Survey for Type 1 Diabetes (GMSS-T1D) and the Diabetes Technology Attitudes Scale (DTAS). The GMSS-T1D measures satisfaction with glucose monitoring device (e.g., meter, continuous glucose monitoring system). The total score can range from 1 to 5 and was calculated by averaging all 15 survey items. A higher score indicates more satisfaction. The DTAS measures attitudes about diabetes devices and technology. The total score can range from 5 to 25 and was calculated by summing all 5 survey items. A higher score indicates more positive attitudes about diabetes devices and technology. Change in attitudes toward device use from 0 to 12 months will be compared within and between the intervention group and control group. | Some participants did not complete surveys at some time points, and thus there are some missing data. | Posted | Mean | Standard Deviation | Score on a survey | 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis) |
|
|
|
|
| 0 |
| 95 |
| 4 |
| 95 |
| 0 |
| 95 |
| EG001 | Intervention Group - Year 2 - No Intervention Sessions | The Intervention Group will receive the monthly intervention sessions during the first year of the study. | 0 | 95 | 6 | 95 | 0 | 95 |
| EG002 | Control Group - Year 1 - No Intervention Sessions | The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year). | 0 | 96 | 13 | 96 | 0 | 96 |
| EG003 | Control Group - Year 2 - Intervention Sessions | The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year). | 0 | 96 | 8 | 96 | 0 | 96 |
| Hospitalization - Not diabetes-related | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| A1c at Month 6 |
|
|
| A1c at Month 12 |
|
|
| .023 |
| Other |
| Month 12 - Intervention vs. Control | t-test, 2 sided | .042 | Other |
| Month 6 - PAID-Peds score |
|
|
| Month 12 - PAID-Peds score |
|
|
| .092 |
| Other |
| PAID-Peds score at Month 12 - Intervention vs. Control | t-test, 2 sided | .103 | Other |
| GMSS Score at Month 6 |
|
|
| GMSS Score at Month 12 |
|
|
| DTAS Score at Month 0 |
|
|
| DTAS Score at Month 6 |
|
|
| DTAS Score at Month 12 |
|
|
| .355 |
| Other |
| GMSS Score at Month 12 - Intervention vs. Control | t-test, 2 sided | .186 | Other |
| DTAS Score at Month 0 - Intervention vs. Control | t-test, 2 sided | .632 | Other |
| DTAS Score at Month 6 - Intervention vs. Control | t-test, 2 sided | .872 | Other |
| DTAS Score at Month 12 - Intervention vs. Control | t-test, 2 sided | .755 | Other |