The REPOSE (Relative Effectiveness of Pumps Over MDI and Structured Education) Trial
REPOSE
The Relative Effectiveness of Pumps Over Multiple Dose Injections and Structured Education Trial
6 other identifiers
interventional
267
1 country
8
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2011
Typical duration for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 2, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedJanuary 26, 2021
January 1, 2021
3.6 years
May 2, 2012
January 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
2 years
Secondary Outcomes (17)
The proportion of participants reaching the NICE target of an HbA1c level of 7.5% (58mmol/mol) or less
6, 12 and 24 months
Diabetes specific quality of life
6, 12 and 24 months
Hypoglycaemia (severe & moderate)
6, 12 and 24 months
Insulin dose
6, 12 and 24 months
Body weight
6, 12 and 24 months
- +12 more secondary outcomes
Study Arms (2)
Multiple daily injections plus DAFNE
ACTIVE COMPARATOROptimised MDI therapy using rapid and twice daily (Detemir/Levemir) long-acting insulin analogues
CSII (Insulin Pump) plus DAFNE
EXPERIMENTALMedtronic MiniMed Paradigm Veo Insulin pumps (X54)
Interventions
Medtronic MiniMed Paradigm Veo Insulin pumps (X54)
Optimised MDI therapy using rapid and twice daily (Detemir/Levemir) long-acting insulin analogues
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trustlead
- Cambridge University Hospitals NHS Foundation Trustcollaborator
- NHS Dumfries & Gallowaycollaborator
- NHS Lothiancollaborator
- NHS Greater Glasgow and Clydecollaborator
- Harrogate & District NHS Foundation Trustcollaborator
- King's College Hospital NHS Trustcollaborator
- Nottingham University Hospitals NHS Trustcollaborator
- National Institute for Health Research, United Kingdomcollaborator
Study Sites (8)
Addenbrookes Wolfson Diabetes and Endocrine Clinic, Box 281, Addenbrookes Hospital, Hills Road
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Harrogate District Hospital, Diabetes Centre, Lancaster Park Road,
Harrogate, North Yorkshire, HG2 7SX, United Kingdom
Dumfries and Galloway Royal Infirmary, Diabetes Centre, Cluden West, Crichton Hall,
Dumfries, Scotland, DG1 4TG, United Kingdom
Royal Infirmary of Edinburgh, Department of Diabetes, 51 Little France Crescent
Edinburgh, Scotland, EH16 4SA, United Kingdom
Stobhill ACH, Diabetes Clinic, 133 Balornock Road
Glasgow, Scotland, G21 3UW, United Kingdom
Sheffield Teaching Hospital, Diabetes Centre, Northern General Hospital, PO Box 1, Herries Road
Sheffield, South Yorkshire, S5 7AU, United Kingdom
Kings College Hospital, Diabetes Centre, Suite 3, Golden Jubilee Wing, Denmark Hill
London, SE5 9RS, United Kingdom
Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus, Derby Road
Nottingham, NG7 2UH, United Kingdom
Related Publications (3)
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.
PMID: 28360027RESULTHeller 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.
PMID: 28440211RESULTBradburn 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.
PMID: 32438024DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Heller, Prof
University of Sheffield
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2012
First Posted
June 12, 2012
Study Start
November 1, 2011
Primary Completion
June 1, 2015
Study Completion
November 1, 2015
Last Updated
January 26, 2021
Record last verified: 2021-01