Type 1 Diabetes MellitusNCT00745342
Optimizing Adherence and Glycemia in Youth With New Insulin-dependent Diabetes Mellitus (IDDM)
A study testing Family Teamwork Intervention in people with Type 1 Diabetes Mellitus, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
This 2-year randomized, controlled trial examined the impact of a clinic-based, family teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Family Teamwork Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Oct 2002
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8 to 17 years old
- Duration of type 1 diabetes between 2 months and 6 years
- Residence in New England or New York
- At least 1 outpatient visit in the past year
Who cannot join
- Major co-morbid psychiatric or medical illness in youth
- Diagnosis of an active major psychiatric disorder in either parent
- Diagnosis of a life-threatening medical illness in either parent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Adherence and Glycemia in Youth With New IDDM
This 2-year randomized, controlled trial examined the impact of a clinic-based, family teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Family Teamwork Intervention
- Keywords
- type 1 diabetes, glycemic control, family conflict, quality of life, parental involvement
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Teamwork InterventionBehavioural
Families in the teamwork group received quarterly psychoeducational interventions at regular clinic visits, focusing on promoting family teamwork and reducing diabetes-specific family conflict and diabetes burnout.
| Study group | Role | What they receive |
|---|---|---|
| Teamwork Group | Experimental | Families randomized to the Teamwork Group received the behavioral family teamwork intervention. Receives: Behavioral: Family Teamwork Intervention |
| Standard Care | No intervention | Families in the Standard Care group received standard diabetes care and equal attention from study staff between visits to schedule appointments and encourage regular diabetes follow-up care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control, assessed by hemoglobin A1c
Change in A1c from baseline to 2 years, measured every 3 months
Measured: 2 years
Secondary outcomes (3)
Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey
Measured at baseline, 1 year, and 2 years
Measured: 2 years
Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions)
Measured at baseline, 1 year, and 2 years
Measured: 2 years
Parent involvement in diabetes management tasks, measured using the Diabetes Family Responsibility Questionnaire (youth and parent versions)
Measured at baseline, 1 year, and 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startMar 1999
- Primary completionOct 2002
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Laffel, Joslin Diabetes Center
- Investigators
- Lori MB Laffel, MD, MPH, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745342
- Sponsor's protocol ID
- 92-23
- Other IDs
- R01DK046887
- Status last verified
- Aug 2021
- First submitted
- 29 Aug 2008
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anderson BJ, Vangsness L, Connell A, Butler D, Goebel-Fabbri A, Laffel LM. Family conflict, adherence, and glycaemic control in youth with short duration Type 1 diabetes. Diabet Med. 2002 Aug;19(8):635-42. doi: 10.1046/j.1464-5491.2002.00752.x.
PubMed 12147143Laffel LM, Vangsness L, Connell A, Goebel-Fabbri A, Butler D, Anderson BJ. Impact of ambulatory, family-focused teamwork intervention on glycemic control in youth with type 1 diabetes. J Pediatr. 2003 Apr;142(4):409-16. doi: 10.1067/mpd.2003.138.
PubMed 12712059Laffel LM, Connell A, Vangsness L, Goebel-Fabbri A, Mansfield A, Anderson BJ. General quality of life in youth with type 1 diabetes: relationship to patient management and diabetes-specific family conflict. Diabetes Care. 2003 Nov;26(11):3067-73. doi: 10.2337/diacare.26.11.3067.
PubMed 14578241
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Adherence and Glycemia in Youth With New IDDM
- ClinicalTrials.gov ID
- NCT00745342
- Acronym / sponsor ID
- 92-23
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes, glycemic control, family conflict, quality of life, parental involvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 1999
- Primary completion
- Oct 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 3 Sep 2008 (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.
This 2-year randomized, controlled trial examined the impact of a clinic-based, family teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teamwork Group | Experimental | Behavioral: Family Teamwork InterventionFamilies randomized to the Teamwork Group received the behavioral family teamwork intervention. |
| Standard Care | No intervention | –Families in the Standard Care group received standard diabetes care and equal attention from study staff between visits to schedule appointments and encourage regular diabetes follow-up care. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 8 to 17 years old
- Duration of type 1 diabetes between 2 months and 6 years
- Residence in New England or New York
- At least 1 outpatient visit in the past year
Key exclusion criteria (3 listed)
- Major co-morbid psychiatric or medical illness in youth
- Diagnosis of an active major psychiatric disorder in either parent
- Diagnosis of a life-threatening medical illness in either parent
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 |
|---|---|---|
| Family Teamwork InterventionFamilies in the teamwork group received quarterly psychoeducational interventions at regular clinic visits, focusing on promoting family teamwork and reducing diabetes-specific family conflict and diabetes burnout. | Behavioural | Teamwork Group |
Primary outcome
Glycemic control, assessed by hemoglobin A1c
Time frame: 2 years
Change in A1c from baseline to 2 years, measured every 3 months
3 secondary outcomes
Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey
Time frame: 2 years
Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions)
Time frame: 2 years
Parent involvement in diabetes management tasks, measured using the Diabetes Family Responsibility Questionnaire (youth and parent versions)
Time frame: 2 years
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 4 Aug 2021.
- Results publication: PubMed 12147143Anderson BJ, Vangsness L, Connell A, Butler D, Goebel-Fabbri A, Laffel LM. Family conflict, adherence, and glycaemic control in youth with short duration Type 1 diabetes. Diabet Med. 2002 Aug;19(8):635-42. doi: 10.1046/j.1464-5491.2002.00752.x.
- Results publication: PubMed 12712059Laffel LM, Vangsness L, Connell A, Goebel-Fabbri A, Butler D, Anderson BJ. Impact of ambulatory, family-focused teamwork intervention on glycemic control in youth with type 1 diabetes. J Pediatr. 2003 Apr;142(4):409-16. doi: 10.1067/mpd.2003.138.
- Results publication: PubMed 14578241Laffel LM, Connell A, Vangsness L, Goebel-Fabbri A, Mansfield A, Anderson BJ. General quality of life in youth with type 1 diabetes: relationship to patient management and diabetes-specific family conflict. Diabetes Care. 2003 Nov;26(11):3067-73. doi: 10.2337/diacare.26.11.3067.
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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.
Lori MB Laffel, MD, MPH principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Teamwork Intervention in people with Type 1 Diabetes Mellitus, run by Joslin Diabetes Center 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 4 inclusion and 3 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 4 Aug 2021. 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 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?
Glycemic control, assessed by hemoglobin A1c (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00745342, which also lists 3 linked publications.
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 4 Aug 2021.