Type 2 Diabetes Treated With Insulin
Conditions
Keywords
Type 2 diabetes, lifestyle intervention, insulin pump treatment, body weight, body composition
Brief summary
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.
Detailed description
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.
Interventions
OTHERDiet and physical activity program
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
Sponsors
AGIR à Dom
Icadom
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult Type 2 diabetic patients with indication of initiation of insulin pump therapy. * Patients addressed for the insulin pump follow-up to the home care provider supporting the study. * Public health care security affiliation.
Exclusion criteria
* Breastfeeding or pregnant woman. * Not willing to participate as assessed by the investigator. * Patient engaged in another clinical trial with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight change | 6 months | The difference in body weight changes between the two groups over a six-month period following initiation of insulin pump treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | 6 months | The difference in HbA1c changes between the two groups after 6-months of insulin pump treatment initiation. |
| Body composition | 6 months | 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. |
| Diabetes Treatment Satisfaction | 6 months | 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. |
| Intermediate weight change | 3 months | The difference in weight changes between the two groups after 3-months of insulin pump treatment initiation. |
| Retention of weight change | 1 year | The difference in weight changes between the two groups at 12-months of insulin pump treatment initiation. |
Countries
France
Outcome results
None listed