Type 1 Diabetes MellitusTotCampNCT02432586
Pilot Study: Intensive Education in a Residential Camp Setting for Families of Young Children With Type 1 Diabetes
A study testing Intensive Education in people with Type 1 Diabetes Mellitus, run by University of Texas Southwestern Medical Center.
Trial summary
18 preschool aged children and their families will attend structured, multidisciplinary, family-centered intensive education sessions over a 3-day weekend in a residential camp setting to address the unique challenges of managing type 1 diabetes mellitus in young children. Read more about this study
- Who is it for?
- Ages 34 to 68 months
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Intensive Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jan 2017
- Phase
- Interventional
- 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 34 to 68 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-5.5 years old (+/- 2 months) at the date of first camp session they are eligible to join.
- Child and Parents fluent in either English or Spanish.
- Type 1 diabetes mellitus diagnosed for at least 10 months previous to date of first camp they are eligible to join.
- Taking insulin
- Custodial parent or guardian (preferable both parents or guardians) willing to attend both session of camp and the activities scheduled for them.
- Parent or guardian must sign consent before any study procedures are performed.
Who cannot join
- Neonatal diabetes (diagnosis in the first 3 months of life) or documented MODY; i.e., a likely genetic form of diabetes rather than an autoimmune etiology.
- Post-surgical diabetes (e.g., pancreatectomy for congenital hyperinsulinism). Such patients often cannot secrete glucagon, leading to a particularly severe inability to defend against hypoglycemia.
- Other severe chronic disease (e.g., cancer, cystic fibrosis) which in the judgment of the investigator is likely to significantly affect glycemic control.
- Patients cannot be taking systemic corticosteroids at enrollment because of adverse effects on glycemic control, but we will not disqualify subjects who require such therapy during the study. Inhaled or topical corticosteroids are permissible.
- Patients with hypothyroidism or hyperthyroidism must be clinically euthyroid and have free T4 and TSH within age-appropriate reference ranges at last medically indicated testing. Patients with out of range values may be retested after medication dose adjustment.
- Developmental delay or behavioral disorder in the patient of sufficient severity, in the judgment of the investigator, to interfere with group activities.
- Medical or psychiatric disorder in a parent of sufficient severity, in the judgment of the investigator, to interfere with group activities.
- Celiac disease is not an exclusion criterion.
About this study
18 preschool aged children and their families will attend structured, multidisciplinary, family-centered intensive education sessions over a 3-day weekend in a residential camp setting to address the unique challenges of managing type 1 diabetes mellitus in young children. A second 'booster' session, will be conducted 6 months later.
Read the detailed description
We propose to deliver a structured multidisciplinary family-centered intervention over a 3-day weekend, with a second similar "booster" session 6 months later. The intervention will be based at our regional diabetes camp, Camp Sweeney. The proposed camp encounters aim to provide:
- An opportunity for intensive education beyond that achievable in a single class, and without the unfavorable impacts of multiple weekday classes on family and work time.
- Varied educational modalities including didactic sessions, practical demonstrations and role playing.
- Close observation of each child throughout the day and night by experienced diabetes counselors and medical staff to identify and help correct maladaptive family behaviors.
- A safe environment where parents can participate in group therapy sessions without child care worries.
- An opportunity for age-appropriate child-centered educational and therapeutic activities.
- An opportunity for families to form mutually-supportive friendships.
- Fun weekends away where the parents have help caring for their diabetic children.
We will conduct this pilot study, which will enroll 18 preschool children age 3-5.5 years, with the goal of obtaining preliminary results for 15 subjects.
The primary outcome, to be determined approximately one month before and after each of the two camp sessions, is improvement in Hemoglobin A1c (HbA1c). This outcome will be compared with that of historical controls.
Exploratory Hypotheses:
Compared with pretreatment baseline and historical controls, subjects attending two 3-day sessions at a family diabetes camp will improve:
- HbA1c 3 months after the first camp session
- Hypoglycemia frequency, as measured by continuous glucose monitoring
- Medical system utilization, as measured by telephone call frequency and also by emergency room visits and hospitalizations
- Behavioral/QoL assessments, including the parents of young children version of the hypoglycemia fear survey (HFS-P-YC), the Behavioral Pediatrics Feeding Assessment Scale (BPFAS), and the general and diabetes modules of the PedsQL.
- Diabetes knowledge, assessed by questionnaire
- Development of friendships between subject families, assessed by questionnaire
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Intensive Education
- Keywords
- T1DM, Diabetes, Child, Toddler
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive EducationBehavioural
Participants will attend a 3 day family-centered, multidisciplinary, intensive education session at our regional diabetes camp, Camp Sweeney. A second 'booster' session will be conducted 6 months later.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Education | Other | Attendance of 2 intensive education sessions Receives: Behavioral: Intensive Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c one month pre-camp to one month post-camp Session 1
As compared to historical controls
Measured: One month pre-camp, one month post-camp
Change in Hemoglobin A1c one month pre-camp to one month post-camp Session 2
As compared to historical controls
Measured: One month pre-camp, one month post-camp
Secondary outcomes (13)
Change in Hypoglycemia frequency one month pre-camp to one month post-camp Session 1
As measured by continuous glucose monitoring, and quantitated as area under the curve for blood glucoses <70 mg/dL.
Measured: One month pre-camp, one month post-camp
Change in Hypoglycemia frequency one month pre-camp to one month post-camp Session 2
As measured by continuous glucose monitoring, and quantitated as area under the curve for blood glucoses <70 mg/dL.
Measured: One month pre-camp, one month post-camp
Medical system utilization ( emergency room visits, hospitalizations related to T1DM)
Composite measure. As compared to historical controls.
Measured: Duration of participation in study, expected to be 10 months
Change in PedsQL Family Impact Module one month pre-camp to one month post-camp Session 1
Parent report
Measured: One month pre-camp, one month post-camp
Change in PedsQL Family Impact Module one month pre-camp to one month post-camp Session 2
Parent report
Measured: One month pre-camp, one month post-camp
Change in PedsQL Pediatric Quality of Life Inventory one month pre-camp to one month post-camp Session 1
Parent report for Toddlers, Parent report for Young Children, Young Child Report
Measured: One month pre-camp, one month post-camp
Change in PedsQL Pediatric Quality of Life Inventory one month pre-camp to one month post-camp Session 2
Parent report for Toddlers, Parent report for Young Children, Young Child Report
Measured: One month pre-camp, one month post-camp
Change in PedsQL Diabetes Module one month pre-camp to one month post-camp Session 1
Parent report for Toddlers, Parent report for Young Children, Young Child Report
Measured: One month pre-camp, one month post-camp
Change in PedsQL Diabetes Module one month pre-camp to one month post-camp Session 2
Parent report for Toddlers, Parent report for Young Children, Young Child Report
Measured: One month pre-camp, one month post-camp
Change in Hypoglycemia Fear Survey one month pre-camp to one month post-camp Session 1
Parents of young children version
Measured: One month pre-camp, one month post-camp
Change in Hypoglycemia Fear Survey one month pre-camp to one month post-camp Session 2
Parents of young children version
Measured: One month pre-camp, one month post-camp
Change in Behavioral Pediatrics Feeding Assessment one month pre-camp to one month post-camp Session 1
Behavior section
Measured: One month pre-camp, one month post-camp
Change in Behavioral Pediatrics Feeding Assessment one month pre-camp to one month post-camp Session 2
Behavior section
Measured: One month pre-camp, one month post-camp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startJul 2014
- Primary completionAug 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perrin White, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432586
- Sponsor's protocol ID
- STU 042014-061
- Acronym
- TotCamp
- Status last verified
- Jun 2017
- First submitted
- 10 Mar 2015
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Intensive Education in a Residential Camp Setting for Families of Young Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02432586
- Acronym / sponsor ID
- TotCamp / STU 042014-061
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- T1DM, Diabetes, Child, Toddler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 4 May 2015 (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.
18 preschool aged children and their families will attend structured, multidisciplinary, family-centered intensive education sessions over a 3-day weekend in a residential camp setting to address the unique challenges of managing type 1 diabetes mellitus in young children. A second 'booster' session, will be conducted 6 months later.
Detailed description
We propose to deliver a structured multidisciplinary family-centered intervention over a 3-day weekend, with a second similar "booster" session 6 months later. The intervention will be based at our regional diabetes camp, Camp Sweeney. The proposed camp encounters aim to provide:
- An opportunity for intensive education beyond that achievable in a single class, and without the unfavorable impacts of multiple weekday classes on family and work time.
- Varied educational modalities including didactic sessions, practical demonstrations and role playing.
- Close observation of each child throughout the day and night by experienced diabetes counselors and medical staff to identify and help correct maladaptive family behaviors.
- A safe environment where parents can participate in group therapy sessions without child care worries.
- An opportunity for age-appropriate child-centered educational and therapeutic activities.
- An opportunity for families to form mutually-supportive friendships.
- Fun weekends away where the parents have help caring for their diabetic children.
We will conduct this pilot study, which will enroll 18 preschool children age 3-5.5 years, with the goal of obtaining preliminary results for 15 subjects.
The primary outcome, to be determined approximately one month before and after each of the two camp sessions, is improvement in Hemoglobin A1c (HbA1c). This outcome will be compared with that of historical controls.
Exploratory Hypotheses:
Compared with pretreatment baseline and historical controls, subjects attending two 3-day sessions at a family diabetes camp will improve:
- HbA1c 3 months after the first camp session
- Hypoglycemia frequency, as measured by continuous glucose monitoring
- Medical system utilization, as measured by telephone call frequency and also by emergency room visits and hospitalizations
- Behavioral/QoL assessments, including the parents of young children version of the hypoglycemia fear survey (HFS-P-YC), the Behavioral Pediatrics Feeding Assessment Scale (BPFAS), and the general and diabetes modules of the PedsQL.
- Diabetes knowledge, assessed by questionnaire
- Development of friendships between subject families, assessed by questionnaire
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive Education | Other | Behavioral: Intensive EducationAttendance of 2 intensive education sessions |
Who may qualify
- Ages
- 34 to 68 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 3-5.5 years old (+/- 2 months) at the date of first camp session they are eligible to join.
- Child and Parents fluent in either English or Spanish.
- Type 1 diabetes mellitus diagnosed for at least 10 months previous to date of first camp they are eligible to join.
- Taking insulin
- Custodial parent or guardian (preferable both parents or guardians) willing to attend both session of camp and the activities scheduled for them.
Key exclusion criteria (8 listed)
- Neonatal diabetes (diagnosis in the first 3 months of life) or documented MODY; i.e., a likely genetic form of diabetes rather than an autoimmune etiology.
- Post-surgical diabetes (e.g., pancreatectomy for congenital hyperinsulinism). Such patients often cannot secrete glucagon, leading to a particularly severe inability to defend against hypoglycemia.
- Other severe chronic disease (e.g., cancer, cystic fibrosis) which in the judgment of the investigator is likely to significantly affect glycemic control.
- Patients cannot be taking systemic corticosteroids at enrollment because of adverse effects on glycemic control, but we will not disqualify subjects who require such therapy during the study. Inhaled or topical corticosteroids are permissible.
- Patients with hypothyroidism or hyperthyroidism must be clinically euthyroid and have free T4 and TSH within age-appropriate reference ranges at last medically indicated testing. Patients with out of range values may be retested after medication dose adjustment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive EducationParticipants will attend a 3 day family-centered, multidisciplinary, intensive education session at our regional diabetes camp, Camp Sweeney. A second 'booster' session will be conducted 6 months later. | Behavioural | Intensive Education |
Primary outcome
Change in Hemoglobin A1c one month pre-camp to one month post-camp Session 1
Time frame: One month pre-camp, one month post-camp
As compared to historical controls
Change in Hemoglobin A1c one month pre-camp to one month post-camp Session 2
Time frame: One month pre-camp, one month post-camp
As compared to historical controls
13 secondary outcomes
Change in Hypoglycemia frequency one month pre-camp to one month post-camp Session 1
Time frame: One month pre-camp, one month post-camp
Change in Hypoglycemia frequency one month pre-camp to one month post-camp Session 2
Time frame: One month pre-camp, one month post-camp
Medical system utilization ( emergency room visits, hospitalizations related to T1DM)
Time frame: Duration of participation in study, expected to be 10 months
Change in PedsQL Family Impact Module one month pre-camp to one month post-camp Session 1
Time frame: One month pre-camp, one month post-camp
Change in PedsQL Family Impact Module one month pre-camp to one month post-camp Session 2
Time frame: One month pre-camp, one month post-camp
Change in PedsQL Pediatric Quality of Life Inventory one month pre-camp to one month post-camp Session 1
Time frame: One month pre-camp, one month post-camp
Change in PedsQL Pediatric Quality of Life Inventory one month pre-camp to one month post-camp Session 2
Time frame: One month pre-camp, one month post-camp
Change in PedsQL Diabetes Module one month pre-camp to one month post-camp Session 1
Time frame: One month pre-camp, one month post-camp
Change in PedsQL Diabetes Module one month pre-camp to one month post-camp Session 2
Time frame: One month pre-camp, one month post-camp
Change in Hypoglycemia Fear Survey one month pre-camp to one month post-camp Session 1
Time frame: One month pre-camp, one month post-camp
Change in Hypoglycemia Fear Survey one month pre-camp to one month post-camp Session 2
Time frame: One month pre-camp, one month post-camp
Change in Behavioral Pediatrics Feeding Assessment one month pre-camp to one month post-camp Session 1
Time frame: One month pre-camp, one month post-camp
Change in Behavioral Pediatrics Feeding Assessment one month pre-camp to one month post-camp Session 2
Time frame: One month pre-camp, one month post-camp
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Perrin White, MD principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Education in people with Type 1 Diabetes Mellitus, run by University of Texas Southwestern Medical Center.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Hemoglobin A1c one month pre-camp to one month post-camp Session 1 (time frame: One month pre-camp, one month post-camp). The study lists 2 primary outcomes in all. 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 23 Jun 2017; AzTrials last refreshed its copy on 30 Oct 2026.