Diabetes Mellitus, Type 1NCT02839174
Type One Diabetes and Low Carb Study
An observational study of Diabetes Mellitus, Type 1, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The investigators have identified a support group on social media with ~1500 members (children and adults), the majority of whom have T1DM and follow a carbohydrate-restricted diet. Many participants report exceptionally low HbA1C and insulin requirements. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Mar 2017
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The social media group on Facebook, TYPEONEGRIT, includes approximately 1500 members, the majority of whom reportedly have type 1 diabetes and follow a carbohydrate-restricted diet.
Who may be able to join
- Adult patients with a diagnosis of T1DM who are currently on insulin treatment or
- Adults who are a parent or guardian of a child with T1DM who is currently on insulin treatment and
- Self-reported use of a regimen including carbohydrate restriction for at least 3 months
Who cannot join
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Investigation of Glycemic Control Among an International Community of People With Type 1 Diabetes Following a Low Carbohydrate Diet
The investigators have identified a support group on social media with ~1500 members (children and adults), the majority of whom have T1DM and follow a carbohydrate-restricted diet. Many participants report exceptionally low HbA1C and insulin requirements. If these anecdotal reports are reflective of a large group of people with type 1 diabetes, a clinical trial would be warranted.
The investigators propose to survey the above-mentioned group and their professional diabetes care providers to characterize glycemic control and explore associated dietary and diabetes care factors.
Read the detailed description
The surveys will address questions in the following domains: 1) Diabetes diagnosis and treatment; 2) Carbohydrate-restricted diet; 3) Insulin regimen; 4) Other diabetes related care; 5) Diabetes complications; 6) Other related health and healthcare; 7) Patient provider interactions; 8) Socio-demographics. Drafts of these surveys are included in the appendix of this protocol.
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- low carbohydrate diet
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
self reported, confirmed by professional diabetes care provider if possible
Measured: within 3 month of taking the survey
Secondary outcomes (6)
total daily insulin dose
self reported, confirmed by professional diabetes care provider if possible
Measured: within 3 month of taking the survey
total daily dietary carbohydrate
self reported
Measured: within 3 month of taking the survey
diabetes-related complication rates - diabetic ketoacidosis, hypoglycemia
Measured: timeframe since staring low carb diet (at least three months)
BMI
self reported, confirmed by professional diabetes care provider if possible
Measured: within 3 month of taking the survey
change in HbA1C
self reported, confirmed by professional diabetes care provider if possible
Measured: current (within three months of taking the survey) - baseline (last available pre-carbohydrate-restricted diet)
patient-physician relationship
self reported, complemented by professional diabetes care provider if possible
Measured: within 3 month of taking the survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belinda Lennerz, Boston Children's Hospital
- Investigators
- Belinda Lennerz, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839174
- Sponsor's protocol ID
- P00022864
- Status last verified
- Jun 2017
- First submitted
- 14 Jul 2016
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Deidentified data will be shared with external collaborators.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Glycemic Control Among an International Community of People With Type 1 Diabetes Following a Low Carbohydrate Diet
- ClinicalTrials.gov ID
- NCT02839174
- Acronym / sponsor ID
- P00022864
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- low carbohydrate diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 20 Jul 2016 (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 investigators have identified a support group on social media with ~1500 members (children and adults), the majority of whom have T1DM and follow a carbohydrate-restricted diet. Many participants report exceptionally low HbA1C and insulin requirements. If these anecdotal reports are reflective of a large group of people with type 1 diabetes, a clinical trial would be warranted.
The investigators propose to survey the above-mentioned group and their professional diabetes care providers to characterize glycemic control and explore associated dietary and diabetes care factors.
Detailed description
The surveys will address questions in the following domains: 1) Diabetes diagnosis and treatment; 2) Carbohydrate-restricted diet; 3) Insulin regimen; 4) Other diabetes related care; 5) Diabetes complications; 6) Other related health and healthcare; 7) Patient provider interactions; 8) Socio-demographics. Drafts of these surveys are included in the appendix of this protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The social media group on Facebook, TYPEONEGRIT, includes approximately 1500 members, the majority of whom reportedly have type 1 diabetes and follow a carbohydrate-restricted diet.
Key inclusion criteria (3 listed)
- Adult patients with a diagnosis of T1DM who are currently on insulin treatment or
- Adults who are a parent or guardian of a child with T1DM who is currently on insulin treatment and
- Self-reported use of a regimen including carbohydrate restriction for at least 3 months
Key exclusion criteria (1 listed)
- Women who are pregnant or breastfeeding.
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
Hemoglobin A1C
Time frame: within 3 month of taking the survey
self reported, confirmed by professional diabetes care provider if possible
6 secondary outcomes
total daily insulin dose
Time frame: within 3 month of taking the survey
total daily dietary carbohydrate
Time frame: within 3 month of taking the survey
diabetes-related complication rates - diabetic ketoacidosis, hypoglycemia
Time frame: timeframe since staring low carb diet (at least three months)
BMI
Time frame: within 3 month of taking the survey
change in HbA1C
Time frame: current (within three months of taking the survey) - baseline (last available pre-carbohydrate-restricted diet)
patient-physician relationship
Time frame: within 3 month of taking the survey
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 9 Jun 2017.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared with external collaborators.
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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.
Belinda Lennerz principal investigator
Boston Children's Hospital
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 Diabetes Mellitus, Type 1, run by Boston Children's Hospital 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 3 inclusion and 1 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 9 Jun 2017. 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?
Hemoglobin A1C (time frame: within 3 month of taking the survey). 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 9 Jun 2017.