NCT03669770

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
Last Updated

September 13, 2018

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

June 28, 2018

Last Update Submit

September 12, 2018

Conditions

LipohypertrophyType 1 Diabetes Mellitus

Keywords

LipohypertrophyType 1 Diabetes MellitusUltrasoundGlucose variabilityGlycaemic control

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6 Weeks

Other Outcomes (6)

  • Time patient spends in the hypoglycaemic/ hyperglycaemic state

    6 weeks

  • Various glucose variability measures

    6 Weeks

  • Changes of the Insulin dosage requirements

    6 Weeks

  • +3 more other outcomes

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All T1DM patients attending the diabetes clinics in GSTFT thought to have have LH and fitting the above criteria.

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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.
  • Using Continuous Subcutaneous Insulin Infusion (CSII)
  • Not undertaking blood glucose tests ≥4 tests per day
  • Unable to speak English or unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care

London, SE1 8WA, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Angus Forbes, Professor

    King's College London

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2018

First Posted

September 13, 2018

Study Start

September 22, 2017

Primary Completion

April 25, 2018

Study Completion

April 25, 2018

Last Updated

September 13, 2018

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)