Benefits of Retained Insulin for Good Health

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Devon and Exeter NHS Foundation Trust

About this trial

The purpose of this research is to understand the impact of retained endogenous insulin (as measured by C-peptide) on quality of life and related outcomes in people living with insulin treated diabetes, and, in those living with type 1 diabetes, to determine the pragmatic and non-pragmatic C-peptide measures which have the strongest association with clinical benefit (including repeated home samples and derived measures of beta cell function). The investigators will do this in two ways:

Firstly, the investigators will extend a large existing prospective study of new adult onset diabetes (Getting the Right Classification and Treatment From Diagnosis in Adults With Diabetes (StartRight)) https://clinicaltrials.gov/ct2/show/NCT03737799) which has followed 1800 participants for median 4 years from diabetes diagnosis. Participants with insulin treated diabetes will be invited to take part in a further research visit remotely or face to face. The investigators will assess the longitudinal relationship between C-peptide and the available quality of life, mental health status and healthcare utilisation measures over up to 9 years from diabetes diagnosis and assess additional measures in cross sectional analysis.

In the second part of this research, the investigators will utilise cohorts of over 2500 participants with type 1 diabetes, measured C-peptide and consent to recontact to recruit 200 participants with a range of C-peptide. Eligible participants with C-peptide measured in clinical care may also be invited to take part. The investigators will undertake detailed assessment of complex and pragmatic measures of C-peptide and beta cell function and compare performance in predicting glycaemic outcomes (using data from continuous glucose monitors) and (where relevant) patient reported outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Previously recruited to the StartRight study (NCT03737799) with consent to be contacted for further research

Clinical diagnosis of diabetes & Insulin treated

Able and willing to provide informed consent/assent.

Aged 18 years or older.

Disqualifiers

None

Trial population

ARM 1: Participants who have previously taken part in the StartRight study (NCT03737799) with consent to re-contact for future research (from sites across the United Kingdom (UK)). ARM 2: Participants who have previously taken part in the StartRight study or other diabetes research cohorts, as well as patients referred by their clinician or self-referred (across the UK).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational

    Other intervention

    Observational

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: Arm 11 intervention
Group B: Arm 21 intervention

Trial outcomes

Primary outcomes

1

Capillary C-peptide measured 1-5 hours after a meal containing carbohydrates (Arm 1)

Analysis of Arm 1 will assess the relationship between home post-meal C-peptide (measured serially from within 12 months of diagnosis up to 10 years post-diagnosis, through extension of an existing study), and the secondary outcomes listed below. This will be assessed as longitudinal change over time (Arm 1 cohort) and cross-sectionally using the most recent visit data from the combined Arm 1 and Arm 2 cohorts.

Time frame
1 day during study participation
2

Plasma and capillary C-peptide (Arm 2)

Primary analysis for Arm 2 will assess the relationship between home capillary C-peptide measurements (post-meal, assessed individually \& as the average of up to three measurements, and 90-minute post-mixed meal tolerance test) and 90-minute plasma C-peptide measured during a mixed meal tolerance test conducted at a research centre. Secondary analysis will compare the relationship between C-peptide measures and the continuous glucose monitoring secondary outcome listed below.

Time frame
90-minutes post baseline

Secondary outcomes

1

Questionnaire assessed hypoglycaemia and hypoglycaemia unawareness (Arm 1 & Arm 2)

Results from analysis of data from Modified Clarke/Edinburgh Hypoglycaemia History questionnaire

Time frame
Symptoms experienced during 4 weeks prior to study enrolment
2

Questionnaire assessed emotional burden (Arm 1 & Arm 2)

Results from analysis of data from Diabetes Distress Scale questionnaire

Time frame
Symptoms experienced during 4 weeks prior to study enrolment
3

Questionnaire assessed quality of life/wellbeing (Arm 1 & Arm 2)

Results from analysis of data from Veterans RAND 12-Item Health Survey (VR-12) questionnaire

Time frame
Symptoms experienced during 4 weeks prior to study enrolment
4

Changes/updates to diabetes treatment, complications and healthcare utilisation for relevant medical conditions since previous study visit (Arm 1)

Data collected during current study visit combined with data from previous study visit.

Time frame
Up to 3 years prior to study enrolment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royal Devon and Exeter NHS Foundation Trust

Lead sponsor

University of Exeter

Collaborator

University of Birmingham

Collaborator