The purpose of the study is to determine whether a personalized lifestyle intervention focused on diet and physical activity reinforcement is effective in avoiding weight gain in the first months following initiation of subcutaneous insulin pump therapy in type-2 diabetic patients.
Patients with type 2 diabetes using insulin pump therapy are gaining weight within the first months of treatment. This weight gain could counterbalance the metabolic benefice of insulin pump treatment in improving glycemic control and could lead to treatment dropout. Lifestyle intervention aiming at improving physical activity and diet in type 2 diabetes is known to brought body weight reduction and cardiometabolic improvement. The investigator hypothesized that an intensive, home-based, 6-months diet and physical activity program could prevent the body weight gain associated with insulin pump treatment initiation. The investigator will randomize patients with type 2 diabetes into a "lifestyle intervention" arm or a "usual care" control arm at the time of insulin pump treatment initiation. The primary objective will evaluate body weight change at 6 months after insulin pump treatment initiation. The secondary objectives will evaluate change in glycemic control (HbA1c) and body composition at 6 months. In addition, the retention effect will be assessed on body weight change one year after insulin pump treatment initiation, 6 months after the end of the lifestyle intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
54
A personalized intervention focused on improving diet and increasing physical activity will be implemented at-home with a monthly support by a registered dietician and physical activity educator during 6 months
Annecy-Genevois Hospital
Annecy, France
Pierre Oudot Hospital
Bourgoin, France
Métropole Savoie Hospital
Chambéry, France
Alpes Léman Hospital
Contamine-sur-Arve, France
Weight change
The difference in body weight changes between the two groups over a six-month period following initiation of insulin pump treatment.
Time frame: 6 months
Glycemic control
The difference in HbA1c changes between the two groups after 6-months of insulin pump treatment initiation.
Time frame: 6 months
Body composition
The difference between the two groups in distribution of fat mass and lean mass between the first visit and 6 months after initiation of insulin pump treatment.
Time frame: 6 months
Diabetes Treatment Satisfaction
The difference between the two groups of scores of the Diabetes Treatment Satisfaction Questionnaire between the first visit and 6 months after initiation of insulin pump treatment.
Time frame: 6 months
Intermediate weight change
The difference in weight changes between the two groups after 3-months of insulin pump treatment initiation.
Time frame: 3 months
Retention of weight change
The difference in weight changes between the two groups at 12-months of insulin pump treatment initiation.
Time frame: 1 year
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Grenoble University Hospital
Grenoble, France
Marseille European Hospital
Marseille, France