Type-1 Diabetes MedDRA version: 16.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Insulin
Product Name: Fast-acting insulin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Con
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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?;Primary end point(s): Change in HbA1c in those participants with and HbA1c greater than or equal to 7.5%;Timepoint(s) of evaluation of this end point: Baseline and 6, 12 and 24 months after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Timepoint(s) of evaluation of this end point: Baseline and 6, 12 and 24 months after intervention | — |
Countries
United Kingdom
Outcome results
None listed