Clinical trial NCT03474393: A Evaluation of Systematic Intensive Therapy Using CGM/FGM in Clinical Diabetes Care
Official title: A Randomised Trial of Evaluating a Systematic Intensive Therapy Using Continuous Glucose Monitoring (CGM) and Flash Glucose Monitoring (FGM) in Clinical Diabetes Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2018-03-22
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to analyse if intensive systematic treatment via internet and telephone during 4 months improved HbA1c for persons with type 1 diabetes which are already treated with CGM or FGM, and if the effect continuous for 1-2 years after the intervention stops. Time in Hypoglycaemia, treatment satisfaction, Diabetes distress and hypoglycaemia fear will even be analysed.

A randomised, non-blinded, multi-centre, clinical study for persons with type 1 diabetes and hbA1c ≥ 58mmol/mol and treated with CGM or FGM.

The control group continuous its normal diabetes care with study visits at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.

The intervention group will have contact with the study team on a weekly basis, when mean blood glucose levels the previous week are elevated. They will receive help with analysing data and advice on how to improve their glucose values. They will even meet the study team at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management)
* Clinical diagnosis of Type 1 diabetes
* Adult patients over 18 years of age
* HbA1c ≥ 58 mmol/mol
* Currently using CGM or FGM
* To have a possibility to download and share FGM/CGM data

Exclusion Criteria:

* Type 2 diabetes
* Diabetes duration \<1 year
* Long-term Systemic glucocorticoid treatment during the last 3 months
* Planned or changed treatment the last 3 months regarding MDI vs. Insulin pump or added or stopped CGM or FGM therapy
* Current or planned pregnancy or breastfeeding during the next 12 months
* Planned move during the next 12 months making it not possible to participate in study activities
* Other reason determined by the investigator not being appropriate for participation

Primary outcomes:
measure: Change in HbA1c
timeFrame: from baseline to 18 weeks
Secondary outcomes:
measure: Time in Range
timeFrame: from baseline to 18 weeks
measure: Mean glucose levels
timeFrame: from baseline to 18 weeks
measure: Time above range
timeFrame: from baseline to 18 weeks
measure: HbA1c at week 32
timeFrame: From baseline to 18 weeks
measure: HbA1c at week 52
timeFrame: From baseline to 52 weeks
Other outcomes:
measure: Mean Glucose at week 32 and 52
timeFrame: From baseline to 32 and 52 weeks
measure: Time below range week 18, 32 and 52
timeFrame: From baseline to 18, 32 and 52 weeks
measure: Time above range weeks 32 and 52
timeFrame: From baseline to weeks 32 and 52
measure: Glycaemic variability - Standard deviation
timeFrame: From baseline to weeks 18, 32 and 52
measure: Glycaemic variability - Coefficient of variation
timeFrame: From baseline to weeks 18, 32 and 52
measure: Glycaemic variability - Mage
timeFrame: From baseline to weeks 18, 32 and 52
measure: DTSQ
timeFrame: From baseline to weeks 18, 32 and 52
measure: Hypoglycaemic confidence
timeFrame: From baseline to weeks 18, 32 and 52
measure: Diabetes distress scale
timeFrame: From baseline to weeks 18, 32 and 52
Locations:
city: Uddevalla
country: Sweden
facility: NU-Hosptial Group
Study officials:
References: