LipohypertrophyTITANICNCT03669770
Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes
An observational study of Lipohypertrophy and Type 1 Diabetes Mellitus, run by King's College London at 1 site in United Kingdom.
Trial summary
This study will use ultrasound to characterise lipohypertrophy(LH) and assess the impact of LH on glucose variability in adults with type 1 diabetes. LH is a condition that occurs with repeated exposure to insulin at injection sites, resulting in the development of subcutaneous fatty lumps that impede the absorption… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lipohypertrophy, Type 1 Diabetes Mellitus
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Sep 2017to 25 Apr 2018
- How long will I take part?
- 2 Months
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All T1DM patients attending the diabetes clinics in GSTFT thought to have have LH and fitting the above criteria.
Who may be able to join
- Adult patients with Type 1 Diabetes Mellitus (T1DM)
- Age> 20 years
- Taking multiple daily injections ≥4 per/day
- Diagnosed T1DM and using insulin for >3 years
- Using the same insulin type and delivery method for past 6 months
- Ability to speak and read English
Show all 9Show fewer
- Case-crossover study:
- Glucose variability with a Standard deviation ≥4mmol/l of mean glucose in the previous four weeks
- ≥4 blood glucose tests per/day
Who cannot join
- Age <20 years
- Type 2 diabetes or Gestational diabetes mellitus (GDM)
- Have a condition or receiving therapies, other than insulin, associated with lipodystrophies
- Have another medical condition or take medicines that may influence blood glucose control (including: currently active cancer; uncontrolled endocrine disorder; eating disorders; celiac disease; and cystic fibrosis)
- Have a serious medical or mental health condition that impairs full engagement in the research
- Using other injectable treatments in diabetes such as growth hormone or glucagon like peptide-1.
Show all 9Show fewer
- Using Continuous Subcutaneous Insulin Infusion (CSII)
- Not undertaking blood glucose tests ≥4 tests per day
- Unable to speak English or unable to give consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care
London, SE1 8WA
About this study
Official title: Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes: The TITANIC Studies.
This study will use ultrasound to characterise lipohypertrophy(LH) and assess the impact of LH on glucose variability in adults with type 1 diabetes. LH is a condition that occurs with repeated exposure to insulin at injection sites, resulting in the development of subcutaneous fatty lumps that impede the absorption of insulin. LH can lead to glucose variability, increased risk of severe hypoglycaemia and diabetes distress. In the long term it can therefore lead to increased risk of diabetes complications and increased insulin costs.
Read the detailed description
This is an observational study using ultrasound (US) to assess and characterise lipohypertrophy (LH) with a sub-study to assess the impact of LH on glucose variability in a case-crossover study.
The study aim is to assess LH using ultrasound and its impact on glucose variability.
The objectives of the study are:
- To use ultrasound to characterise (appearance, location, mass, and distribution) LH tissue in participants with T1DM injecting insulin.
- To develop a standard operating procedure for using US to assess LH.
- To develop a grading system to evaluate LH using US.
- To investigate the relationship between the observed LH and glucose variability, glycaemic control, and/or severe hypoglycaemia.
- To assess quality of life, diabetes distress, and insulin treatment satisfaction after moving to a new injection site and being alerted to the existence of LH.
- To learn more about how people living with type 1 manage their injection sites.
Study design:
All patients attending the diabetes clinics in Guys and St Thomas' Foundation Trust with type 1 diabetes for more than three years and thought to have LH will be offered the opportunity to participate in the study. Those testing their glucose four or more times a day and with a standard deviation of their mean glucose greater than 4mmols, will be offered to participate in the case-crossover arm of the study; a sub-study, which forms a students doctoral studies.
All participants will be asked to give demographic details and medical history. They will be asked to complete a series of questionnaires about their injection technique, diabetes distress, insulin treatment satisfaction and quality of life. All participants will have a baseline glycated haemoglobin taken, and for those in the case-crossover study an additional 1,5-anhydroglucitol and insulin antibody tests done. The case-crossover study with then be fitted with a continuous glucose monitoring (CGM) device to record their glucose variability for the following six days. They will then return for the US assessment of their injection sites and digital palpation; while all other participants in the characterisation study only, will have had this done at the first visit. All participants will be advised as to where they have LH and where they can inject to avoid LH and after five weeks in the case of the case-crossover study return for a second CGM of six days, and then all participant return after six weeks for the final visit.
At this visit they will complete the questionnaires for a second time and a short exit interview will be conduct to gather information on their experience of injecting into a LH free site and injecting insulin. The glycated haemoglobin will be repeated and for the case-crossover study another 1,5-anhydroglucitol will be taken. Finally, the participants will have a session with a diabetes specialist nurse, who will advise them on maintaining a stable glucose level and refer on as appropriate to their diabetes team.
- Conditions
- Lipohypertrophy, Type 1 Diabetes Mellitus
- Keywords
- Lipohypertrophy, Type 1 Diabetes Mellitus, Ultrasound, Glucose variability, Glycaemic control
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Glucose variability between baseline and follow-up
Glucose variability will be measured using the standard deviation of the mean glucose measured at visit 1 and the last visit. For the case-crossover study the data will be taken from the CGM recording and the other participants with their own self-monitoring of glucose measurements.
Measured: 6 weeks
Changes in Glycaemic control between baseline and follow-up
Glycaemic control will be assessed in all participants using glycated haemoglobin at first clinical outpatient appointment and at six weeks. In addition, participants at the case-crossover study will have a 1, 5 anhydroglucitol taken at study visit 1 and at six weeks.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start22 Sep 2017
- Primary completion25 Apr 2018
- Study completion25 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipohypertrophyStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angus Forbes, Professor, Study director, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669770
- Sponsor's protocol ID
- 217187
- Acronym
- TITANIC
- Status last verified
- Aug 2017
- First submitted
- 28 Jun 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes: The TITANIC Studies.
- ClinicalTrials.gov ID
- NCT03669770
- Acronym / sponsor ID
- TITANIC / 217187
- Conditions
- Lipohypertrophy, Type 1 Diabetes Mellitus
- Keywords
- Lipohypertrophy, Type 1 Diabetes Mellitus, Ultrasound, Glucose variability, Glycaemic control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 13 Sep 2018 (actual)
- 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 study will use ultrasound to characterise lipohypertrophy(LH) and assess the impact of LH on glucose variability in adults with type 1 diabetes. LH is a condition that occurs with repeated exposure to insulin at injection sites, resulting in the development of subcutaneous fatty lumps that impede the absorption of insulin. LH can lead to glucose variability, increased risk of severe hypoglycaemia and diabetes distress. In the long term it can therefore lead to increased risk of diabetes complications and increased insulin costs.
Detailed description
This is an observational study using ultrasound (US) to assess and characterise lipohypertrophy (LH) with a sub-study to assess the impact of LH on glucose variability in a case-crossover study.
The study aim is to assess LH using ultrasound and its impact on glucose variability.
The objectives of the study are:
- To use ultrasound to characterise (appearance, location, mass, and distribution) LH tissue in participants with T1DM injecting insulin.
- To develop a standard operating procedure for using US to assess LH.
- To develop a grading system to evaluate LH using US.
- To investigate the relationship between the observed LH and glucose variability, glycaemic control, and/or severe hypoglycaemia.
- To assess quality of life, diabetes distress, and insulin treatment satisfaction after moving to a new injection site and being alerted to the existence of LH.
- To learn more about how people living with type 1 manage their injection sites.
Study design:
All patients attending the diabetes clinics in Guys and St Thomas' Foundation Trust with type 1 diabetes for more than three years and thought to have LH will be offered the opportunity to participate in the study. Those testing their glucose four or more times a day and with a standard deviation of their mean glucose greater than 4mmols, will be offered to participate in the case-crossover arm of the study; a sub-study, which forms a students doctoral studies.
All participants will be asked to give demographic details and medical history. They will be asked to complete a series of questionnaires about their injection technique, diabetes distress, insulin treatment satisfaction and quality of life. All participants will have a baseline glycated haemoglobin taken, and for those in the case-crossover study an additional 1,5-anhydroglucitol and insulin antibody tests done. The case-crossover study with then be fitted with a continuous glucose monitoring (CGM) device to record their glucose variability for the following six days. They will then return for the US assessment of their injection sites and digital palpation; while all other participants in the characterisation study only, will have had this done at the first visit. All participants will be advised as to where they have LH and where they can inject to avoid LH and after five weeks in the case of the case-crossover study return for a second CGM of six days, and then all participant return after six weeks for the final visit.
At this visit they will complete the questionnaires for a second time and a short exit interview will be conduct to gather information on their experience of injecting into a LH free site and injecting insulin. The glycated haemoglobin will be repeated and for the case-crossover study another 1,5-anhydroglucitol will be taken. Finally, the participants will have a session with a diabetes specialist nurse, who will advise them on maintaining a stable glucose level and refer on as appropriate to their diabetes team.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All T1DM patients attending the diabetes clinics in GSTFT thought to have have LH and fitting the above criteria.
Key inclusion criteria (9 listed)
- Adult patients with Type 1 Diabetes Mellitus (T1DM)
- Age> 20 years
- Taking multiple daily injections ≥4 per/day
- Diagnosed T1DM and using insulin for >3 years
- Using the same insulin type and delivery method for past 6 months
Key exclusion criteria (9 listed)
- Age <20 years
- Type 2 diabetes or Gestational diabetes mellitus (GDM)
- Have a condition or receiving therapies, other than insulin, associated with lipodystrophies
- Have another medical condition or take medicines that may influence blood glucose control (including: currently active cancer; uncontrolled endocrine disorder; eating disorders; celiac disease; and cystic fibrosis)
- Have a serious medical or mental health condition that impairs full engagement in the research
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
Changes in Glucose variability between baseline and follow-up
Time frame: 6 weeks
Glucose variability will be measured using the standard deviation of the mean glucose measured at visit 1 and the last visit. For the case-crossover study the data will be taken from the CGM recording and the other participants with their own self-monitoring of glucose measurements.
Changes in Glycaemic control between baseline and follow-up
Time frame: 6 Weeks
Glycaemic control will be assessed in all participants using glycated haemoglobin at first clinical outpatient appointment and at six weeks. In addition, participants at the case-crossover study will have a 1, 5 anhydroglucitol taken at study visit 1 and at six weeks.
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 13 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Lipohypertrophy
Recruiting
The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control
Diabetes Mellitus, Lipohypertrophy
Recruiting
A Trial of Three- and Seven-days Insulin Infusions Set
Type 1 Diabetes
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.
Angus Forbes, Professor study director
King's College London
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 Lipohypertrophy and Type 1 Diabetes Mellitus, run by King's College London at 1 site in United Kingdom.
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 9 inclusion and 9 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 13 Sep 2018. 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 Kingdom. 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?
Changes in Glucose variability between baseline and follow-up (time frame: 6 weeks). 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 13 Sep 2018.