E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045228 |
E.1.2 | Term | Type I diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Are Insulin Pumps or Multiple Insulin Injections More Effective in Treating Adult Type-1 Diabetic Patients when Combined with DAFNE (Dose Adjustment for Normal Eating) Education as assessed by the following outcomes:
Glycosylated Haemoglobin (HbA1c) - A measure of blood glucose control within the previous 6-8 wks. Frequency of hypoglycaemic (low blood sugar) episodes. Body weight. Levels of lipid (cholesterol) and proteinuria (protein in the blood). Frequency of ketoacidosis (high level of ketones in the body) episodes. |
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E.2.2 | Secondary objectives of the trial |
Is there a difference in quality of life and treatment satisfaction between type-1 diabetics treated with pumps or multiple injections as assessed by questionnaires?
If pumps are more effective, why are they so effective, what do patients prefer about them and what would they recommend for pump courses in the future? This is assessed through interviews.
How cost effective are pumps as a method of managing type-1 diabetes when compared to multiple injections as assessed by a health economics model? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Is male or female aged 18 yrs and above - participants mut be old enough to give consent. 2.Have had type-1 diabetes for at least 12 months at the time of the DAFNE course (as assessed by date clinically diagnosed). 3.Is fluent in speaking, reading and understanding English - participants must be able to understand the course. 4.Has no preference to either pump or MDI arm of the study and are happy to be randomised. 5.Is willing to undertake self-monitoring of blood glucose, carbohydrate counting and insulin self adjustment 6. Is willing to change to Detemir Insulin 7. Has a need for structured education to optimise diabetes control in the opinion of the investigator. |
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E.4 | Principal exclusion criteria |
1.Inability to give informed consent. 2.Is pregnant or planning to become pregnant within the next 2 years. 3.Has used an insulin pump within the last 3 years (more than 2 weeks use in the last 3 years) 4.Has already completed a diabetes education course. 5.Has severe needle phobia (i.e. if the phobia might preclude full participation in either treatment arm or influence the participant’s preference for CSII/pump therapy) 6.Has a current history of alcohol or drug abuse. 7.Has a history of heart disease within the past 3 months. 8.Has hypertension that is not under control with hypertensive medication 9.Has renal impairment with a chance of needing renal replacement therapy within the next 2 years 10.Has recurrent episodes of skin infections. 11.Has serious or unstable medical or psychological conditions (a condition active enough to preclude the participant safely taking part in the trial (based on investigatory judgement)). 12.Has taken part in any other investigational clinical trial during the 4 months prior to screening. 13.Has any other issue that may preclude the participant from satisfactory participation in the study based on investigatory judgement. 14. Has a strong need for pump therapy in the opinion of the investigator. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c in those participants with and HbA1c greater than or equal to 7.5% |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline and 6, 12 and 24 months after intervention |
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E.5.2 | Secondary end point(s) |
Biomedical Endpoints: a) Proportion of participants reaching the NICE target of an HbA1c level of 7.5% (58mmol/mol) or less b) Hypoglycaemia (severe & moderate). c) Insulin dose d) Body weight e) Blood lipids & proteinuria f) Diabetic Ketoacidosis
Ancillary Study Endpoints
Quantitative: a) Quality of life (DSQOL, WHOQOLBREF, SF12, EQ5D) b) Fear of hypoglycaemia c) Diabetes Treatment Satisfaction d) Emotional Wellbeing e) Adherence to DAFNE principles f) Use of bolus calculators g) Use of pump features
Qualitative: a) Participant views regarding the pump/multiple injection course & treatment b) Educator views regarding the pump/multiple injection course & treatment
Health Economic: a) Incremental cost-effectiveness ratio b) Sensitivity analyses |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline and 6, 12 and 24 months after intervention |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Multiple injections as opposed to insulin pump |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The point at which it is agreed that we will stop collection of outstanding self-completed questionnaires. This is to allow participants time to return questionnaires that they have taken home from their visit to fill in. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 7 |