Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03048227
Other study ID # UF9773
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 21, 2017
Est. completion date March 21, 2020

Study information

Verified date December 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 15
Est. completion date March 21, 2020
Est. primary completion date March 21, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Continuous Glucose Measurement (CGM)
Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).

Locations

Country Name City State
France CHU de Bordeaux Bordeaux
France CH Sud Francilien Corbeil-essonnes
France CHU de Dijon Dijon
France CHRU de Lille Lille
France AP - Hôpitaux de Marseille Marseille
France UHMontpellier Montpellier
France Chu de Nancy Nancy Vandoeuvre-les-nancy
France AP - Hôpitaux de Paris Paris
France CHRU de Strasbourg Strasbourg
France Chu de Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time spent with glucose Time spent with glucose between 70-180mg/dL last 20 days of intervention period
Secondary HbA1c HbA1c last 20 days of intervention period
Secondary Time spent in hypoglycaemia Time spent in hypoglycaemia (<70mg/dL) last 20 days of intervention period
Secondary Time spent in hyperglycemia Time spent in hyperglycemia (>180mg/dL) last 20 days of intervention period
Secondary Time spent in glucose range Time spent in glucose range [70-180] and [80-140] mg/dL last 20 days of intervention period
Secondary Glucose mean and standard deviation Glucose mean and standard deviation last 20 days of intervention period
Secondary Low Blood Glucose Index (LBGI) Low Blood Glucose Index (LBGI) last 20 days of intervention period
Secondary High Blood Glucose Index (HBGI) High Blood Glucose Index (HBGI) last 20 days of intervention period
Secondary Glucose Variability Glucose Variability: MARD : Mean Absolute Relative Difference last 20 days of intervention period
Secondary Glucose Variability Glucose Variability: MAGE : Mean Amplitude of Glucose Excursions
-MODD : Mean Of daily blood Glucose Difference
last 20 days of intervention period
Secondary Glucose Variability Glucose Variability: MODD : Mean Of daily blood Glucose Difference last 20 days of intervention period
Secondary Number of symptomatique hypoglycaemia, severe et non severe Number of symptomatique hypoglycaemia, severe et non severe last 20 days of intervention period
Secondary Number of pump programmation Number of pump programmation last 20 days of intervention period
Secondary Percentage of sensor use Percentage of sensor use last 20 days of intervention period
Secondary Score of Quality of Life questionnaire (IDSRQ) Score of Quality of Life questionnaire (IDSRQ) last 20 days of intervention period
See also
  Status Clinical Trial Phase
Completed NCT03886974 - Transition to Adult Care in Type 1 Diabetes
Completed NCT05620251 - Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes
Completed NCT03623113 - The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes N/A
Active, not recruiting NCT05078658 - Low-carbohydrate Diet in Children With Type 1 Diabetes N/A
Not yet recruiting NCT06018324 - CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
Withdrawn NCT03736083 - Introducing CGM at Type 1 Diabetes Diagnosis N/A
Completed NCT03177096 - Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes N/A
Not yet recruiting NCT06418269 - The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes N/A
Completed NCT04172077 - Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes
Recruiting NCT04950634 - Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
Completed NCT04450745 - Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients N/A
Completed NCT03165786 - A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes N/A
Terminated NCT04028960 - IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase Phase 2
Recruiting NCT05324488 - Diabetes Registry Graz for Biomarker Research
Completed NCT02984709 - Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes N/A
Completed NCT02984514 - Brown Adipose Tissue in Type 1 Diabetes N/A
Recruiting NCT06372392 - Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps N/A
Recruiting NCT03311516 - New Insulin Therapy by Multiwave Bolus N/A
Recruiting NCT05973799 - Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes N/A
Completed NCT03711656 - Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning Techniques N/A