Type 1 DiabetesPhase 3REPOSENCT01616784
The REPOSE (Relative Effectiveness of Pumps Over MDI and Structured Education) Trial
A Phase 3 study testing CSII (Insulin Pump) plus DAFNE and MDI (levemir® & quick acting insulin) plus DAFNE in people with Type 1 Diabetes, run by Sheffield Teaching Hospitals NHS Foundation Trust at 8 sites in United Kingdom.
Trial summary
For type-1 diabetes, the aim of insulin therapy is to keep blood glucose close to normal while avoiding hypoglycaemia but this is severely limited by the relative crudeness of current insulin delivery in comparison with the physiology of the β-cells which secrete insulin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- CSII (Insulin Pump) plus DAFNE and MDI (levemir® & quick acting insulin) plus DAFNE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- Nov 2011to Nov 2015
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is aged 18 yrs and above.
- Have had type-1 diabetes for at least 12 months (as assessed by date clinically diagnosed).
- Is fluent in speaking, reading and understanding English.
- Has no preference to either CSII or MDI arm of the study and is happy to be randomised.
- Is currently using or willing to switch to Detemir.
- Is willing to undertake self-monitoring of blood glucose (SMBG), carbohydrate counting and insulin self-adjustment. (Enrolment staff should check that any participant with a baseline HbA1c of above 12% is willing to complete SMBG).
- Has a need for structured education to optimise diabetes control in the opinion of the investigator.
Who cannot join
- Inability to give informed consent.
- Is pregnant or planning to become pregnant within the next 2 years.
- Has used CSII within the last 3 years.
- Has already completed a diabetes education course.
- Has severe needle phobia.
- Has a current history of alcohol or drug abuse.
Show all 14Show fewer
- Has a history of heart disease within the past 3 months.
- Has hypertension that is not under control with hypertensive medication (diastolic blood pressure >100mmHg and or sustained systolic level >160).
- Has renal impairment with a chance of needing renal replacement therapy within the next 2 years (Enrolment staff should check that creatinine levels are not above 200 µmol/L).
- Has recurrent episodes of skin infections.
- Has serious or unstable medical or psychological conditions.
- Has taken part in any other investigational clinical trial during the 4 months prior to screening.
- Has any other issue that may preclude the participant from satisfactory participation in the study based on investigatory judgement.
- Has a strong need for pump therapy in the opinion of the investigator.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Addenbrookes Wolfson Diabetes and Endocrine Clinic, Box 281, Addenbrookes Hospital, Hills Road
Cambridge, Cambridgeshire, CB2 0QQ
Dumfries and Galloway Royal Infirmary, Diabetes Centre, Cluden West, Crichton Hall,
Dumfries, Scotland, DG1 4TG
Royal Infirmary of Edinburgh, Department of Diabetes, 51 Little France Crescent
Edinburgh, Scotland, EH16 4SA
Stobhill ACH, Diabetes Clinic, 133 Balornock Road
Glasgow, Scotland, G21 3UW
Harrogate District Hospital, Diabetes Centre, Lancaster Park Road,
Harrogate, North Yorkshire, HG2 7SX
Kings College Hospital, Diabetes Centre, Suite 3, Golden Jubilee Wing, Denmark Hill
London, SE5 9RS
Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus, Derby Road
Nottingham, NG7 2UH
Sheffield Teaching Hospital, Diabetes Centre, Northern General Hospital, PO Box 1, Herries Road
Sheffield, South Yorkshire, S5 7AU
About this study
Official title: The Relative Effectiveness of Pumps Over Multiple Dose Injections and Structured Education Trial
For type-1 diabetes, the aim of insulin therapy is to keep blood glucose close to normal while avoiding hypoglycaemia but this is severely limited by the relative crudeness of current insulin delivery in comparison with the physiology of the β-cells which secrete insulin. Insulin is generally administered by multiple injections MDI with the dose adjusted according to eating and exercise. Insulin can now also be administered using a pump (CSII), which is a device, roughly the size of a mobile phone and containing sufficient insulin to supply both the needs of basal metabolism throughout the day, and the boluses which have to cover meals. The use of CSII is expensive compared to injections, but there are important potential benefits which include improved glycaemic control, reduced risk of hypoglycaemia (low blood sugar) and a more flexible lifestyle and better quality of life. There have been no trials in adults that have compared CSII treatment with MDI where the same structured training in intensive insulin therapy has been given, so the precise benefit of the pump technology is still unclear. There is a need to establish this, and identify patients who benefit the most so that the Department of Health can calculate the proportion of adults that would benefit from CSII therapy and so ensure that commissioning bodies provide the necessary reimbursement. The aim of the trial is therefore to establish the added benefit of CSII therapy over multiple injections on glycaemic control and hypoglycaemia in individuals with Type 1 diabetes receiving similar high quality structured training (Dose Adjustment For Normal Eating:DAFNE) in insulin therapy. Additional assessments will include effects on quality of life and cost effectiveness.
Read the detailed description
The trial is a multi-centre randomised controlled trial whereby between 40 and 49 type-1 diabetic, adult volunteers, aged 18 and above, will be recruited per site from 7 secondary care centres (Sheffield, Kings College Hospital London, Harrogate District Hospital, Addenbrookes Hospital Cambridge, Glasgow Royal Infirmary, Dumfries and Galloway Royal Infirmary and Edinburgh Royal Infirmary). The sites will be required to recruit participants to at least 3 CSII DAFNE (Dose Adjustment for Normal Eating)courses and 3 MDI DAFNE courses. This will mean that in total on the trial, 140 participants are randomised to CSII and 140 to MDI. Participants will be recruited through direct approach if already on the waiting list for a DAFNE course or through advertisement in various clinics.
- Conditions
- Type 1 Diabetes
- Being tested
- CSII (Insulin Pump) plus DAFNE, MDI (levemir® & quick acting insulin) plus DAFNE
- Keywords
- Adult, Diabetes Mellitus, Type 1, Humans, Hypoglycemic Agents, Administration and Dosage, Insulin, Self Care, Health Education, Insulin Infusion Systems, Randomised controlled trial, Patient Education as Topic, Hemoglobin A, Glycosylated
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSII (Insulin Pump) plus DAFNEOther
Also called Continuous subcutaneous insulin infusion, CSII, external insulin pumps
Medtronic MiniMed Paradigm Veo Insulin pumps (X54)
MDI (levemir® & quick acting insulin) plus DAFNEOther
Optimised MDI therapy using rapid and twice daily (Detemir/Levemir) long-acting insulin analogues
| Study group | Role | What they receive |
|---|---|---|
| Multiple daily injections plus DAFNE | Active comparator | Optimised MDI therapy using rapid and twice daily (Detemir/Levemir) long-acting insulin analogues Receives: Other: MDI (levemir® & quick acting insulin) plus DAFNE |
| CSII (Insulin Pump) plus DAFNE | Experimental | Medtronic MiniMed Paradigm Veo Insulin pumps (X54) Receives: Other: CSII (Insulin Pump) plus DAFNE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in HbA1c after 2 years in those participants whose baseline HbA1c was at or above 7.5% (58mmol/mol).
The change in HbA1c after 2 years in those participants whose baseline HbA1c was at or above 7.5% (58mmol/mol).
(Change will be calculated from baseline at 24 months)
Measured: 2 years
Secondary outcomes (17)
The proportion of participants reaching the NICE target of an HbA1c level of 7.5% (58mmol/mol) or less
HbA1c is a measurement of glycosylated haemoglobin which reflects overall blood glucose values over the previous 6-8 weeks(24). This is regarded as the gold standard measure of glycaemic control. There is a strong relationship between HbA1c and the risk of developing long term diabetic complications and it is accepted as a surrogate for long term outcomes in individuals with diabetes.
Since HbA1c can be measured by different techniques we will ensure standardisation by measuring HbA1c in blood samples at a central laboratory.
(Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Diabetes specific quality of life
DSQOL Diabetes-specific quality of life (QoL) will be assessed using the scale DSQOL.
(Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Hypoglycaemia (severe & moderate)
The investigators will record both severe and moderate episodes of hypoglycaemia in participants. This should increase power and identify the ability of CSII to reduce rates of hypoglycaemia. It will also be possible to assess the effects of both, by comparing quality of life measures in those with only moderate hypos, versus those with moderate and severe.
(Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Insulin dose
Some studies have indicated that CSII results in the use of less insulin. We will therefore record participants' self-reported insulin dose at each time point and calculate units/kg body weight.
(Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Body weight
If CSII treatment results in the use of less insulin, it may have a favourable effect on weight since with less insulin there is a propensity for the body to store fewer nutrients. We will therefore record weight at each time point of the trial.
(Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Blood lipids & proteinuria
Blood samples will be taken using local labs and lipids (including HDL cholesterol). Albumin- creatinine ratio (a sensitive measure of proteinuria) will be measured from urine samples.
(Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Diabetic Ketoacidosis
This outcome will be measured through the assessment of any SAE's and AEs.
(Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Fear of hypoglycaemia
The Hypoglycaemia Fear Scale (HFS) is a well validated psychometric tool assessing participants fear of hypoglycaemia both overall and in terms of behaviour and worry. It has been used to assess the impacts of different hypoglycaemic events such as severe, moderate and mild hypoglycaemic episodes on fear of hypoglycaemia (33). A specific benefit to the HFS is that it may be able to identify participants who are likely to maintain high blood glucose levels, thus aiding understanding of potential reasons for poor glycaemic control.
(Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Diabetes Treatment Satisfaction
The Diabetes Treatment Satisfaction Questionnaire (DTSQ measures treatment satisfaction which refers to an individual's subjective appraisal of their experience of treatment, including ease of use, side effects and efficacy. Improvements in satisfaction are not necessarily accompanied by improvements in QoL; treatment satisfaction can be high despite diabetes having a negative impact on QoL, which is why it is important to measure both separately.
(Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Emotional Wellbeing
The Hospital Anxiety and Depression Scale (HADS) measures anxiety on one subscale and depression on another through the use of 7 questions for each characteristic. It is important to measure emotional wellbeing in the trial as participants may find it easier to manage their condition after DAFNE education or with one of the treatments. This might have a substantial effect on their emotional wellbeing that the QoL measures are not sensitive enough to pick up.
(Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Participant views regarding the pump/multiple injection course & treatment
Participant post course interviews
Participants will be interviewed regarding:
- Understandings of the trial and motivation for participation.
- Views about outcome of randomisation.
- Expectations/concerns about trial participation and (if relevant) change to CSII.
- Experience of/views about the course and (if relevant) change to CSII.
- Changes they have made to diabetes management since the course and short/long terms goals set.
- Likes/dislikes of CSII or MDI treatment. (Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Educator views regarding the pump/multiple injection course & treatment
Educator post course interviews
Educators will be interviewed regarding:
- Insight and experience of what took place on the course. b) Recommendations for future course development.
- Recommendations for support that should be offered to patients who move onto pumps. (Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Costs and Outcomes
Costs and quality adjusted life years will be estimated for each individual recruited to the trial. Mean values for each arm will be calculated.
(Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Incremental cost-effectiveness ratio
Cost-effectiveness will be described using plots of incremental costs and QALYs on the cost-effectiveness plane, together with their associated cost-effectiveness acceptability curves and frontiers. The incremental cost-effectiveness ratio and the probability that CSII will be cost-effective in the range of £20,000-£30,000 per QALY will be the main focus.
(Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Costs
Mean values of cost wll be estimated and the value will be calculated for each individual
(Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
General Quality of Life
This will be measured by 3 different measures, the WHOQOL bref, SF12 and EQ5D.
(Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Quality of adjusted life years
Mean values will be estimated and value will be calculated for each individual (Change will be calculated from baseline at 24 months)
Measured: 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2015
- Study completionNov 2015
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 DiabetesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, NHS Dumfries & Galloway, NHS Lothian, NHS Greater Glasgow and Clyde, Harrogate & District NHS Foundation Trust, King's College Hospital NHS Trust, Nottingham University Hospitals NHS Trust, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Simon Heller, Prof, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616784
- Sponsor's protocol ID
- STH15295
- Other IDs
- 08/107/01, 2010-023198-21, 11/H1002/10, 61215213, 10997 (DRN 628)
- Acronym
- REPOSE
- Status last verified
- Jan 2021
- First submitted
- 2 May 2012
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
REPOSE Study Group. Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE). BMJ. 2017 Mar 30;356:j1285. doi: 10.1136/bmj.j1285.
PubMed 28360027Heller S, White D, Lee E, Lawton J, Pollard D, Waugh N, Amiel S, Barnard K, Beckwith A, Brennan A, Campbell M, Cooper C, Dimairo M, Dixon S, Elliott J, Evans M, Green F, Hackney G, Hammond P, Hallowell N, Jaap A, Kennon B, Kirkham J, Lindsay R, Mansell P, Papaioannou D, Rankin D, Royle P, Smithson WH, Taylor C. A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial. Health Technol Assess. 2017 Apr;21(20):1-278. doi: 10.3310/hta21200.
PubMed 28440211Bradburn MJ, Lee EC, White DA, Hind D, Waugh NR, Cooke DD, Hopkins D, Mansell P, Heller SR. Treatment effects may remain the same even when trial participants differed from the target population. J Clin Epidemiol. 2020 Aug;124:126-138. doi: 10.1016/j.jclinepi.2020.05.001. Epub 2020 May 11.
PubMed 32438024
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relative Effectiveness of Pumps Over Multiple Dose Injections and Structured Education Trial
- ClinicalTrials.gov ID
- NCT01616784
- Acronym / sponsor ID
- REPOSE / STH15295
- Conditions
- Type 1 Diabetes
- Keywords
- Adult, Diabetes Mellitus, Type 1, Humans, Hypoglycemic Agents, Administration and Dosage, Insulin, Self Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, NHS Dumfries & Galloway, NHS Lothian, NHS Greater Glasgow and Clyde, Harrogate & District NHS Foundation Trust, King's College Hospital NHS Trust, Nottingham University Hospitals NHS Trust, National Institute for Health Research, United Kingdom
- Study start
- Nov 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 12 Jun 2012 (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.
For type-1 diabetes, the aim of insulin therapy is to keep blood glucose close to normal while avoiding hypoglycaemia but this is severely limited by the relative crudeness of current insulin delivery in comparison with the physiology of the β-cells which secrete insulin. Insulin is generally administered by multiple injections MDI with the dose adjusted according to eating and exercise. Insulin can now also be administered using a pump (CSII), which is a device, roughly the size of a mobile phone and containing sufficient insulin to supply both the needs of basal metabolism throughout the day, and the boluses which have to cover meals. The use of CSII is expensive compared to injections, but there are important potential benefits which include improved glycaemic control, reduced risk of hypoglycaemia (low blood sugar) and a more flexible lifestyle and better quality of life. There have been no trials in adults that have compared CSII treatment with MDI where the same structured training in intensive insulin therapy has been given, so the precise benefit of the pump technology is still unclear. There is a need to establish this, and identify patients who benefit the most so that the Department of Health can calculate the proportion of adults that would benefit from CSII therapy and so ensure that commissioning bodies provide the necessary reimbursement. The aim of the trial is therefore to establish the added benefit of CSII therapy over multiple injections on glycaemic control and hypoglycaemia in individuals with Type 1 diabetes receiving similar high quality structured training (Dose Adjustment For Normal Eating:DAFNE) in insulin therapy. Additional assessments will include effects on quality of life and cost effectiveness.
Detailed description
The trial is a multi-centre randomised controlled trial whereby between 40 and 49 type-1 diabetic, adult volunteers, aged 18 and above, will be recruited per site from 7 secondary care centres (Sheffield, Kings College Hospital London, Harrogate District Hospital, Addenbrookes Hospital Cambridge, Glasgow Royal Infirmary, Dumfries and Galloway Royal Infirmary and Edinburgh Royal Infirmary). The sites will be required to recruit participants to at least 3 CSII DAFNE (Dose Adjustment for Normal Eating)courses and 3 MDI DAFNE courses. This will mean that in total on the trial, 140 participants are randomised to CSII and 140 to MDI. Participants will be recruited through direct approach if already on the waiting list for a DAFNE course or through advertisement in various clinics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple daily injections plus DAFNE | Active comparator | Other: MDI (levemir® & quick acting insulin) plus DAFNEOptimised MDI therapy using rapid and twice daily (Detemir/Levemir) long-acting insulin analogues |
| CSII (Insulin Pump) plus DAFNE | Experimental | Other: CSII (Insulin Pump) plus DAFNEMedtronic MiniMed Paradigm Veo Insulin pumps (X54) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is aged 18 yrs and above.
- Have had type-1 diabetes for at least 12 months (as assessed by date clinically diagnosed).
- Is fluent in speaking, reading and understanding English.
- Has no preference to either CSII or MDI arm of the study and is happy to be randomised.
- Is currently using or willing to switch to Detemir.
Key exclusion criteria (14 listed)
- Inability to give informed consent.
- Is pregnant or planning to become pregnant within the next 2 years.
- Has used CSII within the last 3 years.
- Has already completed a diabetes education course.
- Has severe needle phobia.
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 |
|---|---|---|
| CSII (Insulin Pump) plus DAFNEAlso: Continuous subcutaneous insulin infusion, CSII, external insulin pumpsMedtronic MiniMed Paradigm Veo Insulin pumps (X54) | Other | CSII (Insulin Pump) plus DAFNE |
| MDI (levemir® & quick acting insulin) plus DAFNEOptimised MDI therapy using rapid and twice daily (Detemir/Levemir) long-acting insulin analogues | Other | Multiple daily injections plus DAFNE |
Primary outcome
The change in HbA1c after 2 years in those participants whose baseline HbA1c was at or above 7.5% (58mmol/mol).
Time frame: 2 years
The change in HbA1c after 2 years in those participants whose baseline HbA1c was at or above 7.5% (58mmol/mol). (Change will be calculated from baseline at 24 months)
17 secondary outcomes
The proportion of participants reaching the NICE target of an HbA1c level of 7.5% (58mmol/mol) or less
Time frame: 6, 12 and 24 months
Diabetes specific quality of life
Time frame: 6, 12 and 24 months
Hypoglycaemia (severe & moderate)
Time frame: 6, 12 and 24 months
Insulin dose
Time frame: 6, 12 and 24 months
Body weight
Time frame: 6, 12 and 24 months
Blood lipids & proteinuria
Time frame: 6, 12 and 24 months
Diabetic Ketoacidosis
Time frame: 6, 12 and 24 months
Fear of hypoglycaemia
Time frame: 6, 12 and 24 months
Diabetes Treatment Satisfaction
Time frame: 6, 12 and 24 months
Emotional Wellbeing
Time frame: 6, 12 and 24 months
Participant views regarding the pump/multiple injection course & treatment
Time frame: 6, 12 and 24 months
Educator views regarding the pump/multiple injection course & treatment
Time frame: 6, 12 and 24 months
Costs and Outcomes
Time frame: 6, 12 and 24 months
Incremental cost-effectiveness ratio
Time frame: 6, 12 and 24 months
Costs
Time frame: 6, 12 and 24 months
General Quality of Life
Time frame: 6, 12 and 24 months
Quality of adjusted life years
Time frame: 6, 12 and 24 months
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 26 Jan 2021.
- Results publication: PubMed 28360027REPOSE Study Group. Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE). BMJ. 2017 Mar 30;356:j1285. doi: 10.1136/bmj.j1285.
- Results publication: PubMed 28440211Heller S, White D, Lee E, Lawton J, Pollard D, Waugh N, Amiel S, Barnard K, Beckwith A, Brennan A, Campbell M, Cooper C, Dimairo M, Dixon S, Elliott J, Evans M, Green F, Hackney G, Hammond P, Hallowell N, Jaap A, Kennon B, Kirkham J, Lindsay R, Mansell P, Papaioannou D, Rankin D, Royle P, Smithson WH, Taylor C. A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial. Health Technol Assess. 2017 Apr;21(20):1-278. doi: 10.3310/hta21200.
- Derived from this study: PubMed 32438024Bradburn MJ, Lee EC, White DA, Hind D, Waugh NR, Cooke DD, Hopkins D, Mansell P, Heller SR. Treatment effects may remain the same even when trial participants differed from the target population. J Clin Epidemiol. 2020 Aug;124:126-138. doi: 10.1016/j.jclinepi.2020.05.001. Epub 2020 May 11.
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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.
Simon Heller, Prof principal investigator
University of Sheffield
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CSII (Insulin Pump) plus DAFNE and MDI (levemir® & quick acting insulin) plus DAFNE in people with Type 1 Diabetes, run by Sheffield Teaching Hospitals NHS Foundation Trust at 8 sites 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 7 inclusion and 14 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 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The change in HbA1c after 2 years in those participants whose baseline HbA1c was at or above 7.5% (58mmol/mol). (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 NCT01616784, 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 26 Jan 2021.