Type I Diabetes Mellitus Without ComplicationREACT5NCT01390636
Type 1 Diabetes and Eating Disorder Diurnal Glucose Patterns
An observational study of Type I Diabetes Mellitus Without Complication and Eating Disorder, run by HealthPartners Institute at 1 site in United States.
Trial summary
The purpose of this study is to use data from the Continuous Glucose Monitor (CGM) to determine the degree of variation in glucose levels of individuals with an eating disorder and type 1 diabetes and only an eating disorder. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Type I Diabetes Mellitus Without Complication, Eating Disorder
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Current Melrose Institute Patient
Who may be able to join
- Admitted to the ISL unit at Melrose Institute
- Diagnosed with an eating disorder (Anorexia Nervosa, Bulimia Nervosa or Eating Disorder Not Otherwise Specified)
- For ED-DMT1 group: Diagnosis of an eating disorder AND diagnosis of type 1 diabetes.
- For ED/only group: Diagnosis of an eating disorder AND no history/diagnosis of type 1 or type 2 diabetes.
- Female.
- At least 14 years of age.
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- Able to provide informed consent.
- If the potential participant's age is at least 18 years she must be able to provide informed consent.
- If the potential participant is less than 18 years she must have a parent or guardian able and willing to provide written informed consent on the participant's behalf. In addition, the participant must be willing to sign a consent on her own behalf.
- Participants must be able and willing to utilize the CGM system and perform required calibrations using self-monitored blood glucose.
Who cannot join
- Male.
- Age < 14 years.
- History of self-injurious behavior that the senior clinician feels precludes participation.
- Unable to understand the study protocol.
- Unwilling to follow the study protocol.
- Participation in any competing research study.
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- Planned ISL admission for <4 days.
- Pregnant.
- Not able to communicate in English.
- Regular use of acetaminophen or acetaminophen containing medications and not able to modify their medication to a non-acetaminophen based medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterizing Diurnal Glucose Patterns of Individuals With Type 1 Diabetes and Eating Disorders
The purpose of this study is to use data from the Continuous Glucose Monitor (CGM) to determine the degree of variation in glucose levels of individuals with an eating disorder and type 1 diabetes and only an eating disorder.
Read the detailed description
The specific aims of the proposed research are to:
2.1 Determine the degree of variation in glycemic profiles of individuals with an Eating Disorder and Type 1 Diabetes (ED-DMT1) and an Eating Disorder only (ED/only); and
2.2 Determine the impact of nutritional intake and planned physical activity on glucose profiles of individuals with ED-DMT1 and ED/only.
These aims will be examined by characterizing:
- glucose exposure, as measured by area under the Ambulatory Glucose Profile (AGP) median curve;
- glucose variability, as measured by the AGP inter-quartile range; and
- glucose stability, as measured by change in the AGP median curve.
- Keywords
- Continuous Glucose Monitoring, Type 1 Diabetes and an Eating Disorder, Eating Disorder Only
- Medical subject headings
- Feeding and Eating Disorders, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ED-DMT1 and ED/only | Eating Disorder and Type 1 Diabetes and only an Eating Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in Glycemic Profiles of ED-DMT1 and ED/only
Determine the degree of variation in glycemic profiles of individuals with ED-DMT1 and ED/only using Continuous Glucose Monitoring (CGM). CGM will be graphically and statistically represented by an Ambulatory Glucose Profile (AGP).
Measured: 10 days
Secondary outcomes (1)
Impact of Dietary Intake on Glucose Profiles of ED-DMT1 and ED/only
Determine the impact of dietary intake and planned physical activity on glucose profiles of individuals with ED-DMT1 and ED/only using Continuous Glucose Monitoring (CGM). CGM will be graphically and statistically represented by an Ambulatory Glucose Profile (AGP).
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2011
- Study completionMay 2013
Why it stopped: The study was a collaboration that could not be effectively run.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I Diabetes Mellitus Without ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Park Nicollet Foundation, Melrose Institute, International Diabetes Center at Park Nicollet
- Responsible party
- Sponsor
- Investigators
- Mazze S Mazze, PhD, Principal investigator, International Diabetes Center at Park Nicollet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390636
- Sponsor's protocol ID
- 04126-11-C
- Acronym
- REACT5
- Status last verified
- Aug 2013
- First submitted
- 29 Jun 2011
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Diurnal Glucose Patterns of Individuals With Type 1 Diabetes and Eating Disorders
- ClinicalTrials.gov ID
- NCT01390636
- Acronym / sponsor ID
- REACT5 / 04126-11-C
- Keywords
- Continuous Glucose Monitoring, Type 1 Diabetes and an Eating Disorder, Eating Disorder Only
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was a collaboration that could not be effectively run.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Park Nicollet Foundation, Melrose Institute, International Diabetes Center at Park Nicollet
- Study start
- Jul 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to use data from the Continuous Glucose Monitor (CGM) to determine the degree of variation in glucose levels of individuals with an eating disorder and type 1 diabetes and only an eating disorder.
Detailed description
The specific aims of the proposed research are to:
2.1 Determine the degree of variation in glycemic profiles of individuals with an Eating Disorder and Type 1 Diabetes (ED-DMT1) and an Eating Disorder only (ED/only); and
2.2 Determine the impact of nutritional intake and planned physical activity on glucose profiles of individuals with ED-DMT1 and ED/only.
These aims will be examined by characterizing:
- glucose exposure, as measured by area under the Ambulatory Glucose Profile (AGP) median curve;
- glucose variability, as measured by the AGP inter-quartile range; and
- glucose stability, as measured by change in the AGP median curve.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ED-DMT1 and ED/only | – | –Eating Disorder and Type 1 Diabetes and only an Eating Disorder |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Current Melrose Institute Patient
Key inclusion criteria (10 listed)
- Admitted to the ISL unit at Melrose Institute
- Diagnosed with an eating disorder (Anorexia Nervosa, Bulimia Nervosa or Eating Disorder Not Otherwise Specified)
- Female.
- At least 14 years of age.
- Able to provide informed consent.
Key exclusion criteria (10 listed)
- Male.
- Age < 14 years.
- History of self-injurious behavior that the senior clinician feels precludes participation.
- Unable to understand the study protocol.
- Unwilling to follow the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variation in Glycemic Profiles of ED-DMT1 and ED/only
Time frame: 10 days
Determine the degree of variation in glycemic profiles of individuals with ED-DMT1 and ED/only using Continuous Glucose Monitoring (CGM). CGM will be graphically and statistically represented by an Ambulatory Glucose Profile (AGP).
1 secondary outcome
Impact of Dietary Intake on Glucose Profiles of ED-DMT1 and ED/only
Time frame: 10 days
Results and safety
The study was stopped early (reason given: The study was a collaboration that could not be effectively run.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mazze S Mazze, PhD principal investigator
International Diabetes Center at Park Nicollet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type I Diabetes Mellitus Without Complication and Eating Disorder, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was a collaboration that could not be effectively run.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in Glycemic Profiles of ED-DMT1 and ED/only (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2015.