Weight-pump
Background
People with type 2 diabetes on subcutaneous insulin pump therapy experience an increase in weight during the first few months of treatment.
This weight gain may lead to non-adherence to insulin pump treatment and could offset the metabolic benefits associated with improved glycaemic control. An intensive management program aimed at increasing physical activity and improving the dietary behaviour of people with type 2 diabetes has been shown to reduce weight.
The study hypothesis was that participation in an intensive programme to change dietary behaviour and increase physical activity levels would prevent the weight gain that occurs in the months following initiation of subcutaneous insulin pump therapy. Such an intensive dietary and physical activity programme could also help to improve glycaemic control and body composition.
Promoteur
AGIR à dom
Coordination du projet
IC@dom
Type d'étude
Interventional / Clinical investigation in the home
Protocole multicentrique
CHU de Grenoble, Hôpital européen Marseille, CH Alpes Léman, CH Annecy Genevois, CH Métropole Savoie, CH Pierre Oudot
Effectif
54 participants
Study design
Prospective, randomised, comparative, national, multicentre experimental study. Participants were randomised into 2 groups: dietary programme + physical activity and standard care.
IC@dom was commissioned to provide comprehensive support to AGIR à dom at every stage of the clinical investigation:
Project design and management
Drafting the protocol
Drafting the e-CRF (electronic case report form)
Provision of the home-based intervention by a team of dieticians and adapted physical activity instructors
Statistical analysis of data
Promotion of results
Results
Intention-to-treat analysis showed that change in weight 6 months after the initiation of insulin pump therapy (primary outcome) was not different between the control group +3.2 (3.9) kg and the intervention group +3.9 (3.8) kg (Δmean [95% CI] = -0.7 [-2.8; 1.5] kg; p=0.56).
A 6-month, home-based, non-restrictive dietary and physical activity intervention provided after the introduction of insulin pump therapy in people with type 2 diabetes did not prevent weight gain, which appears to be essentially determined by the extent of improvement in glycaemic control.
+3.2 kg
Control group
+ 3.9 kg
Intervention group
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