Type1diabetes
Conditions
Keywords
TIDM, Type1diabetes, Implantable Pump, CGM
Brief summary
During this study, we propose to assess the utility of Continuous Glucose Measurements (CGM) in a group of Type 1 diabetic patients treated with an implanted insulin pump. Patients will participate in two period of 3 months separated by a 3 months washout. During one period, they will use CGM to adapt their insulin therapy while during the other period, they will manage their diabetes with their usual capillary blood glucose meter. We except to observe an increase of time spent in glucose safe range when using CGM.
Detailed description
Glucose control and quality of life of patients with type 1 diabetes with high glucose variability can be improve with use of an implanted pump which delivers insulin by the intra-peritoneal route. Some patients however still have difficulties to achieve their glycemic goal despite this therapy. Continuous Glucose Measurements (CGM) has proven to be able to improve glucose control (HbA1c, time spent in hypoglycaemia) of patients treated with an external insulin pump. No trial has been performed yet to assess the utility of CGM on patients using an intra-peritoneal insulin delivery. During this study, we propose to assess the influence of CGM use on type 1 diabetic subject treated with implanted insulin pump. It is a prospective, randomized cross-over study. After a 2 weeks run-in period with CGM followed by a 4 weeks break, subjects will participate at two experimental periods of 3 months separated with a 3 month washout. During the intervention phase, patient will use a CGM system (Abbott Freestyle Navigator II) to adapt their insulinotherapy. During the control period, patients will based their insulinotherapy upon their usual care and capillary glucose measurements. The order of the periods will be randomized. The main endpoint will be the time spent in glucose interval 70-180mg/dL during the last 20 days of each period. The control arm will wear a blinded sensor during this phase to allow comparison.
Interventions
DEVICEContinuous Glucose Measurement (CGM)
Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 and 70 * Type 1 diabetes for at least 1 year * Treatment of diabetes withimplanted insulin pump for at least 6 months * HbA1c level between 7.5 and 10% * Minimum of 4 capillary glucose controls per day over past 3 months * Use of CGM at least 75% during run-in period * Willingness to follow all study procedures * Informed consent signed * Patient must be affiliated or beneficiary of a social medical insurance
Exclusion criteria
* Pregnancy of breast feeding, or intention to be pregnant during the study duration * Impaired cognitive or psychological abilities which may result in defective adherence to study procedures * Any disease which could make the use glucose sensor difficult (ex : blindness, severe arthrosis or immobility) * Known allergy to medical adhesive or glucose sensor component * Medication affecting glucose metabolism, unless stable during the study * Long term use of continuous glucose measurements during pas 6 months * Pump implanted more than 6 years ago * Anti-insulin antobodies syndrom * Active enrollment in another clinical trial or participation in a study within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time spent with glucose | last 20 days of intervention period | Time spent with glucose between 70-180mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time spent in hypoglycaemia | last 20 days of intervention period | Time spent in hypoglycaemia (\<70mg/dL) |
| Time spent in hyperglycemia | last 20 days of intervention period | Time spent in hyperglycemia (\>180mg/dL) |
| Time spent in glucose range | last 20 days of intervention period | Time spent in glucose range \[70-180\] and \[80-140\] mg/dL |
| Glucose mean and standard deviation | last 20 days of intervention period | Glucose mean and standard deviation |
| Low Blood Glucose Index (LBGI) | last 20 days of intervention period | Low Blood Glucose Index (LBGI) |
| HbA1c | last 20 days of intervention period | HbA1c |
| Glucose Variability | last 20 days of intervention period | Glucose Variability: MARD : Mean Absolute Relative Difference |
| Number of symptomatique hypoglycaemia, severe et non severe | last 20 days of intervention period | Number of symptomatique hypoglycaemia, severe et non severe |
| Number of pump programmation | last 20 days of intervention period | Number of pump programmation |
| Percentage of sensor use | last 20 days of intervention period | Percentage of sensor use |
| Score of Quality of Life questionnaire (IDSRQ) | last 20 days of intervention period | Score of Quality of Life questionnaire (IDSRQ) |
| High Blood Glucose Index (HBGI) | last 20 days of intervention period | High Blood Glucose Index (HBGI) |
Countries
France
Outcome results
None listed