Impact of Smart Connected Insulin Pens on Quality of Life in Dependent Patients with Diabetes Using Continuous Glucose Measurement

ConditionDiabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Sud Francilien

About this trial

Insulin-treated diabetes in dependent or institutionalized patients is often poorly balanced and continuous glucose measurement is underused. The purpose of this tudy is to know how smart connected insulin pens and continuous glucose measurement can improve insulin therapy practice in dependent and/or institutionalized patients?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Older than 18 years patient with type 1 or 2 diabetes

Treated with multiple insulin injections

Equipped with a continuous glucose measurement system and smart connected insulin pens at least one month before

Dependent on a health professional for treatment management.

Disqualifiers

None

Trial population

patient managed by a caregivers for the management of insulin therapy at home or in nursing home or in healthcare facility.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Counseling home caregivers

    Behavioral

    Advice on the proper use of insulin therapy will be given, if necessary, to caregivers. Patients are reviewed at 1 month of this first visit with a collection of the same data

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Insulin Injection

Percentage of insulin injections not as prescribed

Time frame
at day 0

Secondary outcomes

1

number of missed injections

Percentage of missed injections

Time frame
at day 0
2

number of injections

Percentage of injections performed with a dose deviation of +-20% from the prescribed dose

Time frame
at day 0
3

number of injections

Percentage of injections performed outside the meal time : more than 15 minutes before or more than an hour after the meal.

Time frame
at day 0
4

Continuous glucose measurement parameters

Time in range

Time frame
at day 0

Other outcomes

Sponsors and contacts

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