An interventional study of ACT and Supportive Diabetes Counseling in Type 1 Diabetes, Eating Disorders and Disordered Eating Behaviors, sponsored by Duke University. Recruiting at 2 sites in United States. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
Among 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States — 191 open to participants now, 259 under way, 17 of them phase 3. Diabetes Mellitus, Type 1 · United States.
Among the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States, this one is the 148th largest by planned enrollment of the 1,242 interventional ones that give a count, is one of 66 that started in 2023, is one of 614 with no phase, reaches primary completion later than 133 of the 258 other live ones, and was the 1,196th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →191 of the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States are open now. Recruiting first, the newest first:
University of California, Los Angeles · Sites in United States
Ages 18+
Medtronic MiniMed, Inc. · Sites in United States
Ages 2–80
University of Colorado, Denver · Sites in United States
Ages 10–20
vTv Therapeutics · Sites in United States
Ages 18+
Eli Lilly and Company · Sites in United States
Ages 18–70
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.
This study: 16 Years to 50 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,458 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 206 · Phase 2 267 · Phase 3 167 · Phase 4 74
First in 1983; this study’s year is marked. 66 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 235 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Median enrollment 40 across the 1,242 interventional studies, 64 across the 203 observational. Of the 1,117 that completed or were terminated, 562 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
398 of 1,458 have an industry lead sponsor. The 10 most frequent:
Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Duke University has 8 studies filed under Diabetes Mellitus, Type 1 — fewer than ten, so there is no comparison to draw.
117 of the studies in Diabetes Mellitus, Type 1 with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT07076199Phase 3Novo Nordisk A/SA Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes | 2027-01-25 |
| NCT06334133Phase 3vTv TherapeuticsCadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes | 2027-04 |
| NCT07056699Phase 3The University of Texas Health Science Center at San AntonioSGLT2i, Pioglitazone, and Ketone Production in T1D | 2027-06-01 |
Among the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to test whether a new intervention works to treat eating disorders in type 1 diabetes. Participants are assigned to one of the following: (1) Acceptance and Commitment Therapy (ACT), (2) Supportive Diabetes Counseling, or (3) a 6-month Waitlist Control. Participants in the ACT and Supportive Diabetes Counseling conditions complete 12 sessions over 12-16 weeks and use their mobile phone between sessions to increase engagement and reinforce learning.
The main questions are:
Does treatment improve glycemic levels, eating disorder symptoms, diabetes management and diabetes distress?
Does one treatment do better than the other?
How do the treatments work, if they work, and for whom?
Participants complete assessments that include wearing a continuous glucose sensor and activity watch, and get a blood draw to determine HbA1c. They also complete diagnostic interviews, surveys and computer tests of attention and things like heart rate and reaction time. These assessments help us better understand the types of changes that are happening and how they might influence health and well-being.
This is a randomized controlled trial comparing an Acceptance and Commitment Therapy (ACT) protocol to supportive diabetes counseling (SDC) and a Waitlist Control (WLC) for individuals with type 1 diabetes and disordered eating (or T1DE). Both active conditions are tailored to the needs of individuals living with T1D and the unique conditions under which the eating disorder developed and is maintained. Participants will be 161 individuals with T1D, between the ages of 16-50, with binge-purge eating disorders (EDs), including threshold and subthreshold bulimia nervosa, binge eating disorder and purging disorder. Purging includes restriction of insulin for weight loss. An expansion cohort of 74 persons with T1D and elevated Diabetes Eating Problems Survey-Revised scores (DEPS-R=>20) will also be recruited to assess the utility of the treatments for a broader array of eating and weight control problems in T1D. Participants will be randomized to either ACT, SDC, or a WLC and complete assessments at baseline, mid-treatment, end-of-treatment, and at 1 month, 3 months, and 6 months post-treatment. The primary outcome of interest for power and sample size calculation is blood glucose levels (mean and % time in target glycemic range) as assessed by continuous glucose monitoring. Other outcomes include change in hemoglobin A1c (HbA1c), eating disorder symptoms, diabetes self-management and, secondary, diabetes distress. In addition to examining clinical outcomes, this study tests biobehavioral mechanisms of change and predictors of treatment response. Process of change assessments focus on flexible responding to pathology-relevant stimuli and early improvement in glycemic control affecting executive function. The primary site is Duke University Medical Center. The Miriam Hospital is a secondary site.
Primary Cohort
Inclusion Criteria:
Expansion Cohort
Inclusion Criteria:
Primary and Expansion Cohort
Exclusion Criteria:
ACT-T1DE consists of 12 sessions of flexible ACT protocol tailored to the unique conditions and needs of type 1 diabetes eating disorders. The protocol is based on an initial pilot study (Merwin et al., 2021); however, the current protocol has been modified, based on key stakeholder feedback and to optimize real-world implementation. Modifications include transition from the use of a mobile app to a text messaging platform and a combination of in-person and virtual visits.
Behavioral: ACT
The SDC condition is a flexible protocol of 12 sessions consisting of supportive listening, psychoeducation about diabetes and its management and management problems, and goal setting, informed by the ADA Type 1 Diabetes Self-Care Manual and ADCES7 Self-Care Behaviors framework.
Behavioral: Supportive Diabetes Counseling
Participants assigned to the Waitlist Control complete assessments but do not receive intervention.
Treatment is based on Acceptance and Commitment Therapy (ACT), a contemporary cognitive behavioral therapy (CBT) that improves human functioning and adaptability by increasing psychological flexibility. Individual therapy sessions are paired with mobile phone delivered interventions.
Counseling with a diabetes educator knowledgeable about disordered eating in type 1 diabetes. Intervention focuses on supportive listening, diabetes-related education, including management problems and goal setting.
Change in glycemic control as indexed by continuous glucose monitoring (CGM)
CGM indices of time in target glycemic range, mean blood sugar, frequency of Level 1 and 2 hyperglycemia and blood glucose variability
Time frame: baseline, 6 weeks, 12 weeks, 36 weeks
Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey-Revised (DEPS-R)
Severity of eating and body image concerns, frequency of engagement in maladaptive eating and weight control behaviors, specifically in the context of diabetes. Scores range from 0-80, with higher scores indicating greater symptom severity (worse outcome).
Time frame: baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks
Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire
Engagement in activities necessary to manage diabetes, including checking blood sugar and administering insulin. Scores range from 0-10 with higher scores indicating better self-management.
Time frame: baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks
Change in glycemic control as indexed by hemoglobin A1c (HbA1c)
Glycated hemoglobin (percentage of red blood cells that are glycated providing an estimate of average blood glucose over 3 months)
Time frame: baseline, 24 weeks, 36 weeks
Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale
Feelings of stress or overwhelm with the burden of living with diabetes and diabetes management. Scores range from 1-6, with higher scores indicating greater distress (worse outcome)
Time frame: baseline, 12 weeks, 24 weeks, 36 weeks
CompACT-10
A 10-item measure of general (rather than diabetes-specific) psychological flexibility. This measure includes component processes of open, aware and engaged, allowing for more in-depth assessment of process of change. This is the primary psychological flexibility measure in the current trial.
Time frame: Baseline, Mid-Treatment, 12 weeks, 16 weeks, 24 weeks, 36 weeks.
Acceptance and Action Diabetes Questionnaire (AADQ)
Assesses psychological flexibility (process of change) in the context of diabetes specific thoughts and feelings.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Valuing Questionnaire (VQ)
Assesses outcomes expected in an ACT intervention. The VQ consists of 2 Subscales: Values Obstruction and Values Progress. Values Obstruction measures the extent to which thoughts/feelings obstructed engagement in values. Values Progress measures the extent to which an individual made progress in areas of life that are important to them.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Executive function
Computer-administered Stroop and a GoNoGo paradigm. Outcomes of interest are interference or bias score and errors and reaction time (respectively). These measures are included to test the hypothesis that executive function is improved with the improvement of eating disorder symptoms and glycemic control.
Time frame: Baseline, 12 weeks, 36 weeks
High Frequency Heart Rate Variability (HF-HRV)
Assesses physiological flexibility/adaptability in the presence of emotional stimuli as an exploratory process of change measure.
Time frame: Baseline, 12 weeks, 36 weeks
Actigraphy
Measures sleep and physical activity as exploratory measures of behavioral mechanisms of change.
Time frame: Baseline, 12 weeks, 36 weeks
Ecological Momentary Assessment (EMA)
Participants complete questions at home using their mobile phone assessing psychological flexibility, mood, eating and diabetes management behavior, for additional data with high ecological validity. The assessment also aims to test the hypothesis that negative mood is decoupled from problem behavior over the course of treatment.
Time frame: Baseline, 12 weeks, 36 weeks
Change in Eating Disorder Examination - Questionnaire (EDE-Q)
Self-report version of the Eating Disorder Examination (EDE). The EDE includes a total score and 4 subscale scores: Restraint, Eating Concerns, Weight Concerns, Shape Concerns. It is included to capture aspects of ED not assessed by the DEPS, as well as diagnostic outcome or change.
Time frame: Baseline, 16 weeks, 24 weeks, 36 weeks
GAD-7
7-Item assessment of anxiety. The primary purpose for inclusion is as a control variable.
Time frame: Baseline, 12 weeks, 36 weeks
PHQ-9
9-Item assessment of Depression. The primary purpose for inclusion is as a control variable.
Time frame: Baseline, 12 weeks, 36 weeks
T1DE Questionnaire
This is a 20-item questionnaire developed for the purposes of this trial. The questionnaire is an inventory of target behaviors for individuals with T1DE.
Time frame: Baseline, End-of-Treatment, 3 Months, 6 Months
Working Alliance Inventory - Short Revised
This is a 13-item self-report questionnaire that measures experiences individuals have with their therapy or therapist. It includes three subscale scores: goal items, task items, and bond items. It is included as a potential moderator of treatment effects.
Time frame: Mid-treatment
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Jun 2027, 50 months after the start.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 50 months is above that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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