CompletedNot Applicable

Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Poorly Controlled Diabetes Type 1 Patients

France19 participantsStarted 2016-01-01

Plain-language summary

Patients with diabetes type 1 with poor glycemic control will be switched to insulin pump and FGM system (Flash Glucose Monitoring) during 6 months, correlated to the hypothesis that they could benefit from this intervention by being reengaged in diabetes self-management.

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * adults with type 1 diabetes, aged between 18 and 55, HbA1c \>9% (75 mmol/mol), multi daily insulin injections (MDI) treatment, maximum 2 SMBG /day Exclusion Criteria: * diabetes with less than 1 year duration, severe active retinopathy requiring laser therapy, severe psychiatric illness, pregnancy, inability to communicate in French, concomitant severe active disease, patients already using a FGM or a CGM

What they're measuring

Change in HbA1c ≥1%

Timeframe: 6 months

Number of severe hypoglycemia episodes

Timeframe: 6 months

Number of ketoacidosis episodes

Timeframe: 6 months

Trial details

NCT IDNCT03671161

SponsorGroupe Hospitalier Pitie-Salpetriere

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07-01

View on ClinicalTrials.gov More Glucose Metabolism Disorders (Including Diabetes Mellitus) trials