Type 1 Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPsychoeducation to reduce diabetes distress and improve glycemic outcomes
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.
Sponsors
Joslin Diabetes Center
Stanford University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Age 14-25 years * Diagnosis of type 1 diabetes (according to ADA criteria) * Type 1 diabetes duration ≥12 months * A1c 7-13% * Smartphone or regular access to wifi via computer * Fluency in English at a 5th grade level or higher (based on investigator assessment of grade level in school or highest grade level achieved and presence in mainstream academic classes)
Exclusion criteria
* Physical or mental health condition that in the determination of the investigators may limit the ability to fully participate in the study (e.g., autism) * Participation in another intervention study within the last 3 months * Currently pregnant or intending to become pregnant during the study (assessed by self-report)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range (TIR) | 0, 3, 6, 9, 12, 15, 18, 21, and 24 months (months 0-12 reported for primary outcome analysis) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A1c | 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis) | 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. |
| Diabetes Distress | 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis) | 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. |
| Attitudes Toward Diabetes Device Use | 0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLori M Laffel, MD, MPH
Joslin Diabetes Center
PRINCIPAL_INVESTIGATORKorey K Hood, PhD
Stanford University
Participant flow
Recruitment details
217 participants provided informed consent and 191 were randomized.
Pre-assignment details
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)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 19.9 years STANDARD_DEVIATION 3.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 82 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 77 Participants |
| Sex/Gender, Customized Female | 56 Participants |
| Sex/Gender, Customized Male | 54 Participants |
| Sex/Gender, Customized Nonbinary or other | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 95 | 0 / 96 | 0 / 96 |
| other Total, other adverse events | 0 / 95 | 0 / 95 | 0 / 96 | 0 / 96 |
| serious Total, serious adverse events | 4 / 95 | 6 / 95 | 13 / 96 | 8 / 96 |
Outcome results
None listed