Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00818142
Other study ID # 03653-07-A
Secondary ID
Status Completed
Phase N/A
First received January 5, 2009
Last updated November 30, 2015
Start date January 2008
Est. completion date December 2010

Study information

Verified date August 2013
Source HealthPartners Institute
Contact n/a
Is FDA regulated No
Health authority United States: Park Nicollet Institute Institutional Review Board
Study type Observational

Clinical Trial Summary

We propose to conduct a monthly group of persons with type 1 diabetes who also withhold insulin. Subjects will be asked to complete a 2-page survey (check-in sheet) at the beginning of each session and a 5-page survey (Diabetes and Eating Disorders Survey) on their first session and at their last session of their group.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Have an eating disorder

- Have type 1 diabetes

- Withhold their insulin

- 18 years or older

- Actively being treated at EDI

- Committed to at least one appointment each month with each member of their individual EDI team (RD, CDE or RN, CDE; LP; and MD)

- Approval of participation by EDI/DM team (RD; RN; LP; MD)

- Able to attend 66% of group sessions

Exclusion Criteria:

- Psychologically not ready for this group therapy

- Have additional eating disorder issues that would make attendance in this group inappropriate

- Not committed to continuing treatment at PN's EDI

- Not being actively treated at PN's EDI

- Has type 2 diabetes

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Behavioral:
ED/DM Support Group
The ED/DM Recovery Group focuses on assisting individuals with diabetes and an eating disorder - specifically the struggle of withholding insulin. The group utilizes strategies and tools that have been taught in other EDI programs, and also builds on the strengths of a group. The group is a means for learning and support as the individuals continue a regular schedule of school, work, and/or family life.

Locations

Country Name City State
United States Park Nicollet Eating Disorder Institute Minneapolis Minnesota

Sponsors (4)

Lead Sponsor Collaborator
HealthPartners Institute International Diabetes Center at Park Nicollet, Park Nicollet Eating Disorder Institute, Park Nicollet Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

Colton P, Olmsted M, Daneman D, Rydall A, Rodin G. Disturbed eating behavior and eating disorders in preteen and early teenage girls with type 1 diabetes: a case-controlled study. Diabetes Care. 2004 Jul;27(7):1654-9. — View Citation

Goebel-Fabbri AE, Fikkan J, Connell A, Vangsness L, Anderson BJ. Identification and treatment of eating disorders in women with type 1 diabetes mellitus. Treat Endocrinol. 2002;1(3):155-62. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence to insulin regimen. Monthly No
See also
  Status Clinical Trial Phase
Recruiting NCT05653518 - Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes N/A
Enrolling by invitation NCT05515939 - Evaluating the InPen in Pediatric Type 1 Diabetes
Completed NCT05109520 - Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
Recruiting NCT04016987 - Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes N/A
Active, not recruiting NCT04190368 - Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes N/A
Recruiting NCT05413005 - Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus Early Phase 1
Active, not recruiting NCT04668612 - Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes N/A
Completed NCT02837094 - Enhanced Epidermal Antigen Specific Immunotherapy Trial -1 Phase 1
Recruiting NCT05414409 - The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action Phase 2
Recruiting NCT05670366 - The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes N/A
Active, not recruiting NCT05418699 - Real-life Data From Diabetic Patients on Closed-loop Pumps
Completed NCT04084171 - Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6 N/A
Recruiting NCT06144554 - Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Recruiting NCT05153070 - Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes Phase 2
Recruiting NCT05379686 - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes N/A
Completed NCT05281614 - Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D Early Phase 1
Withdrawn NCT04259775 - Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes N/A
Active, not recruiting NCT01600924 - Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
Completed NCT02855307 - Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes Phase 2
Completed NCT02914886 - Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS) Phase 4