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The REPOSE (Relative Effectiveness of Pumps Over MDI and Structured Education) Trial (REPOSE)

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
CSII (Insulin Pump) plus DAFNE
MDI (levemir® & quick acting insulin) plus DAFNE
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion criteria:

  • 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.

Sites / Locations

  • Addenbrookes Wolfson Diabetes and Endocrine Clinic, Box 281, Addenbrookes Hospital, Hills Road
  • Harrogate District Hospital, Diabetes Centre, Lancaster Park Road,
  • Dumfries and Galloway Royal Infirmary, Diabetes Centre, Cluden West, Crichton Hall,
  • Royal Infirmary of Edinburgh, Department of Diabetes, 51 Little France Crescent
  • Stobhill ACH, Diabetes Clinic, 133 Balornock Road
  • Sheffield Teaching Hospital, Diabetes Centre, Northern General Hospital, PO Box 1, Herries Road
  • Kings College Hospital, Diabetes Centre, Suite 3, Golden Jubilee Wing, Denmark Hill
  • Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus, Derby Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Multiple daily injections plus DAFNE

CSII (Insulin Pump) plus DAFNE

Arm Description

Optimised MDI therapy using rapid and twice daily (Detemir/Levemir) long-acting insulin analogues

Medtronic MiniMed Paradigm Veo Insulin pumps (X54)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Educator views regarding the pump/multiple injection course & treatment
Educator post course interviews Educators will be interviewed regarding: a) Insight and experience of what took place on the course. b) Recommendations for future course development. c) Recommendations for support that should be offered to patients who move onto pumps. (Change will be calculated from baseline at 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)
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)
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)
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)
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)

Full Information

First Posted
May 2, 2012
Last Updated
January 22, 2021
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
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
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1. Study Identification

Unique Protocol Identification Number
NCT01616784
Brief Title
The REPOSE (Relative Effectiveness of Pumps Over MDI and Structured Education) Trial
Acronym
REPOSE
Official Title
The Relative Effectiveness of Pumps Over Multiple Dose Injections and Structured Education Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiple daily injections plus DAFNE
Arm Type
Active Comparator
Arm Description
Optimised MDI therapy using rapid and twice daily (Detemir/Levemir) long-acting insulin analogues
Arm Title
CSII (Insulin Pump) plus DAFNE
Arm Type
Experimental
Arm Description
Medtronic MiniMed Paradigm Veo Insulin pumps (X54)
Intervention Type
Other
Intervention Name(s)
CSII (Insulin Pump) plus DAFNE
Other Intervention Name(s)
Continuous subcutaneous insulin infusion, CSII, external insulin pumps
Intervention Description
Medtronic MiniMed Paradigm Veo Insulin pumps (X54)
Intervention Type
Other
Intervention Name(s)
MDI (levemir® & quick acting insulin) plus DAFNE
Intervention Description
Optimised MDI therapy using rapid and twice daily (Detemir/Levemir) long-acting insulin analogues
Primary Outcome Measure Information:
Title
The change in HbA1c after 2 years in those participants whose baseline HbA1c was at or above 7.5% (58mmol/mol).
Description
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)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The proportion of participants reaching the NICE target of an HbA1c level of 7.5% (58mmol/mol) or less
Description
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)
Time Frame
6, 12 and 24 months
Title
Diabetes specific quality of life
Description
DSQOL Diabetes-specific quality of life (QoL) will be assessed using the scale DSQOL. (Change will be calculated from baseline at 24 months)
Time Frame
6, 12 and 24 months
Title
Hypoglycaemia (severe & moderate)
Description
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)
Time Frame
6, 12 and 24 months
Title
Insulin dose
Description
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)
Time Frame
6, 12 and 24 months
Title
Body weight
Description
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)
Time Frame
6, 12 and 24 months
Title
Blood lipids & proteinuria
Description
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)
Time Frame
6, 12 and 24 months
Title
Diabetic Ketoacidosis
Description
This outcome will be measured through the assessment of any SAE's and AEs. (Change will be calculated from baseline at 24 months)
Time Frame
6, 12 and 24 months
Title
Fear of hypoglycaemia
Description
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)
Time Frame
6, 12 and 24 months
Title
Diabetes Treatment Satisfaction
Description
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)
Time Frame
6, 12 and 24 months
Title
Emotional Wellbeing
Description
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)
Time Frame
6, 12 and 24 months
Title
Participant views regarding the pump/multiple injection course & treatment
Description
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)
Time Frame
6, 12 and 24 months
Title
Educator views regarding the pump/multiple injection course & treatment
Description
Educator post course interviews Educators will be interviewed regarding: a) Insight and experience of what took place on the course. b) Recommendations for future course development. c) Recommendations for support that should be offered to patients who move onto pumps. (Change will be calculated from baseline at 24 months)
Time Frame
6, 12 and 24 months
Title
Costs and Outcomes
Description
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)
Time Frame
6, 12 and 24 months
Title
Incremental cost-effectiveness ratio
Description
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)
Time Frame
6, 12 and 24 months
Title
Costs
Description
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)
Time Frame
6, 12 and 24 months
Title
General Quality of Life
Description
This will be measured by 3 different measures, the WHOQOL bref, SF12 and EQ5D. (Change will be calculated from baseline at 24 months)
Time Frame
6, 12 and 24 months
Title
Quality of adjusted life years
Description
Mean values will be estimated and value will be calculated for each individual (Change will be calculated from baseline at 24 months)
Time Frame
6, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Heller, Prof
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addenbrookes Wolfson Diabetes and Endocrine Clinic, Box 281, Addenbrookes Hospital, Hills Road
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Harrogate District Hospital, Diabetes Centre, Lancaster Park Road,
City
Harrogate
State/Province
North Yorkshire
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
Facility Name
Dumfries and Galloway Royal Infirmary, Diabetes Centre, Cluden West, Crichton Hall,
City
Dumfries
State/Province
Scotland
ZIP/Postal Code
DG1 4TG
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh, Department of Diabetes, 51 Little France Crescent
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Stobhill ACH, Diabetes Clinic, 133 Balornock Road
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G21 3UW
Country
United Kingdom
Facility Name
Sheffield Teaching Hospital, Diabetes Centre, Northern General Hospital, PO Box 1, Herries Road
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Kings College Hospital, Diabetes Centre, Suite 3, Golden Jubilee Wing, Denmark Hill
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus, Derby Road
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28360027
Citation
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.
Results Reference
result
PubMed Identifier
28440211
Citation
Heller 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.
Results Reference
result
PubMed Identifier
32438024
Citation
Bradburn 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.
Results Reference
derived

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The REPOSE (Relative Effectiveness of Pumps Over MDI and Structured Education) Trial

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