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1.  A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design 
Background
Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial.
Methods/design
The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year.
Discussion
In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996.
doi:10.1186/1472-6823-12-10
PMCID: PMC3433358  PMID: 22727048
Type 1 diabetes; Severe hypoglycaemia; Human insulin; Insulin analogues; PROBE
2.  Health-related quality of life and self-related health in patients with type 2 diabetes: Effects of group-based rehabilitation versus individual counselling 
Background
Type 2 diabetes can seriously affect patients' health-related quality of life and their self-rated health. Most often, evaluation of diabetes interventions assess effects on glycemic control with little consideration of quality of life. The aim of the current study was to study the effectiveness of group-based rehabilitation versus individual counselling on health-related quality of life (HRQOL) and self-rated health in type 2 diabetes patients.
Methods
We randomised 143 type 2 diabetes patients to either a six-month multidisciplinary group-based rehabilitation programme including patient education, supervised exercise and a cooking-course or a six-month individual counselling programme. HRQOL was measured by Medical Outcomes Study Short Form 36-item Health Survey (SF-36) and self-rated health was measured by Diabetes Symptom Checklist - Revised (DCS-R).
Results
In both groups, the lowest estimated mean scores of the SF36 questionnaire at baseline were "vitality" and "general health". There were no significant differences in the change of any item between the two groups after the six-month intervention period. However, vitality-score increased 5.2 points (p = 0.12) within the rehabilitation group and 5.6 points (p = 0.03) points among individual counselling participants.
In both groups, the highest estimated mean scores of the DSC-R questionnaire at baseline were "Fatigue" and "Hyperglycaemia". Hyperglycaemic and hypoglycaemic distress decreased significantly after individual counselling than after group-based rehabilitation (difference -0.3 points, p = 0.04). No between-group differences occurred for any other items. However, fatigue distress decreased 0.40 points within the rehabilitation group (p = 0.01) and 0.34 points within the individual counselling group (p < 0.01). In the rehabilitation group cardiovascular distress decreased 0.25 points (p = 0.01).
Conclusions
A group-based rehabilitation programme did not improve health-related quality of life and self-rated health more than an individual counselling programme. In fact, the individual group experienced a significant relief in hyper- and hypoglycaemic distress compared with the rehabilitation group.
However, the positive findings of several items in both groups indicate that lifestyle intervention is an important part of the management of type 2 diabetes patients.
doi:10.1186/1477-7525-9-110
PMCID: PMC3251531  PMID: 22152107
3.  Lifestyle intervention for type 2 diabetes patients – trial protocol of The Copenhagen Type 2 Diabetes Rehabilitation Project 
BMC Public Health  2009;9:166.
Background
Current guidelines recommend education, physical activity and changes in diet for type 2 diabetes patients, yet the composition and organization of non-pharmacological care are still controversial. Therefore, it is very important that programmes aiming to improve non-pharmacological treatment of type 2 diabetes are developed and evaluated. The Copenhagen Type 2 Diabetes Rehabilitation Project aims to evaluate the effectiveness of a new group-based lifestyle rehabilitation programme in a Health Care Centre in primary care.
Methods/Design
The group-based diabetes rehabilitation programme consists of empowerment-based education, supervised exercise and dietary intervention. The effectiveness of this multi-disciplinary intervention is compared with conventional individual counselling in a Diabetes Outpatient Clinic and evaluated in a prospective and randomized controlled trial. During the recruitment period of 18 months 180 type 2 diabetes patients will be randomized to the intervention group and the control group. Effects on glycaemic control, quality of life, self-rated diabetes symptoms, body composition, blood pressure, lipids, insulin resistance, beta-cell function and physical fitness will be examined after 6, 12 and 24 months.
Discussion
The Copenhagen Type 2 Diabetes Rehabilitation Project evaluates a multi-disciplinary non-pharmacological intervention programme in a primary care setting and provides important information about how to organize non-pharmacological care for type 2 diabetes patients.
Trail Registration
ClinicalTrials.gov registration number: NCT00284609.
doi:10.1186/1471-2458-9-166
PMCID: PMC2694179  PMID: 19480671

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