NCT00818142

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 2, 2015

Status Verified

August 1, 2013

Enrollment Period

2.9 years

First QC Date

January 5, 2009

Last Update Submit

November 30, 2015

Conditions

Eating DisorderType 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Adherence to insulin regimen.

    Monthly

Study Arms (1)

eating disorder, type 1 diabetes

Individuals diagnosed with type 1 diabetes and an eating disorder who withhold their insulin.

Behavioral: ED/DM Support Group

Interventions

ED/DM Support GroupBEHAVIORAL

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.

eating disorder, type 1 diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals diagnosed with type 1 diabetes and an eating disorder who manipulate their insulin will be considered to join the ED/DM Recovery Group.

You may qualify if:

  • Have an eating disorder
  • Have type 1 diabetes
  • Withhold their insulin
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Park Nicollet Eating Disorder Institute

Minneapolis, Minnesota, 55416, United States

Location

Related 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. doi: 10.2337/diacare.27.7.1654.

    PMID: 15220242BACKGROUND

  • 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. doi: 10.2165/00024677-200201030-00003.

    PMID: 15799208BACKGROUND

MeSH Terms

Conditions

Feeding and Eating DisordersDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Margaret Powers, PhD, RD, CDE

    International Diabetes Center at Park Nicollet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 7, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 2, 2015

Record last verified: 2013-08

Locations

US(1)