Clinical trial NCT04936633: Efficacy of FSGM Cloud-based Remote Intervention for Insulin-dEpendent Diabetic Patients (FRIEND)
Official title: Efficacy of Remote Intervention by Medical Staff Based on a Cloud System of Continuous Glucose Monitoring Data in Patients With Insulin-dependent Diabetes Using a Flash Sensor-based Glucose Monitoring (FSGM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Remote intervention
Flash sensor-based glucose monitoring
Type 1 diabetes mellitus
Insulin-dependent diabetes mellitus
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy of remote intervention by medical staff based on a cloud system of continuous glucose monitoring data in patients with insulin-dependent diabetes using flash sensor-based glucose monitoring (FSGM).

Detailed description: * Previous studies have been reported on the efficacy of CGM or FSGM and education on glucose control in insulin-dependent diabetes patients.
* This study aims to investigate whether it is more effective to receive remote intervention by medical staff based on a cloud system, than only to use FSGM and receive general education on FSGM.
* Trial design : parallel group, allocation ratio 1:1, a superiority study design

Eligibility criteria: Inclusion Criteria:

* Men or women aged 19 to 75 years old
* Patients with type 1 diabetes
* Patients on multiple daily insulin-injection or continuous subcutaneous insulin infusion therapy for more than 1 year
* Patients with HbA1c ≥ 7.0% at screening
* Patients willing to use a FSGM system
* Patients with informed consent

Exclusion Criteria:

* Gestational diabetes patients
* Patients within 1 year of diabetic diagnosis
* Patients taking drugs for severe cognitive impairment or psychiatric problems
* Patients who received oral or parenteral corticosteroid therapy for more than 7 consecutive days within 1 month before screening test
* Patients with severe infection, before and after surgery, and severe trauma
* Patients on dialysis at the end of renal failure
* Patients who have a history of substance abuse or alcoholism within 12 weeks through patient history taking, diagnosis records, and past treatment records
* Pregnant or lactating women
* Participating in other clinical trials under R\&D other than this clinical trial, or if other clinical trial drugs are administered within 4 weeks before the trial
* Patients who are using a CGMS/FSGM or who have been using it within 12 weeks

Primary outcomes:
measure: Changes in glycemic control measured by HbA1c
timeFrame: 3 months
Secondary outcomes:
measure: Changes in the time in range
timeFrame: 3 months
measure: Changes in the duration of hyperglycemic episodes
timeFrame: 3 months
measure: Changes in the duration of hypoglycemic episodes
timeFrame: 3 months
measure: Changes in hypoglycemic episodes
timeFrame: 3 months
measure: Changes in the mean glucose values
timeFrame: 3 months
measure: Changes in the frequency of use of trend arrows
timeFrame: 3 months
measure: Changes in the mean number of scans
timeFrame: 3 months
measure: Changes in the insulin dose
timeFrame: 3 months
measure: Changes in the lipid parameter
timeFrame: 3 months
measure: Changes in blood pressure
timeFrame: 3 months
measure: Changes in body weight
timeFrame: 3 months
measure: Lifestyle changes in diet
timeFrame: 3 months
measure: Lifestyle changes in the number of exercises
timeFrame: 3 months
measure: Lifestyle changes in the duration of exercises
timeFrame: 3 months
measure: Changes in the patient absolute satisfaction with treatment assessed by questionnaires
timeFrame: 3 months
measure: Changes in the patient relative satisfaction with treatment assessed by questionnaires
timeFrame: 3 months
measure: Changes in depression assessed by questionnaires
timeFrame: 3 months
measure: Changes in anxiety assessed by questionnaires
timeFrame: 3 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
Study officials:
References:
citation: Laffel LM, Kanapka LG, Beck RW, Bergamo K, Clements MA, Criego A, DeSalvo DJ, Goland R, Hood K, Liljenquist D, Messer LH, Monzavi R, Mouse TJ, Prahalad P, Sherr J, Simmons JH, Wadwa RP, Weinstock RS, Willi SM, Miller KM; CGM Intervention in Teens and Young Adults with T1D (CITY) Study Group; CDE10. Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2388-2396. doi: 10.1001/jama.2020.6940.
citation: Pratley RE, Kanapka LG, Rickels MR, Ahmann A, Aleppo G, Beck R, Bhargava A, Bode BW, Carlson A, Chaytor NS, Fox DS, Goland R, Hirsch IB, Kruger D, Kudva YC, Levy C, McGill JB, Peters A, Philipson L, Philis-Tsimikas A, Pop-Busui R, Shah VN, Thompson M, Vendrame F, Verdejo A, Weinstock RS, Young L, Miller KM; Wireless Innovation for Seniors With Diabetes Mellitus (WISDM) Study Group. Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2397-2406. doi: 10.1001/jama.2020.6928.
citation: Hermanns N, Ehrmann D, Schipfer M, Kroger J, Haak T, Kulzer B. The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial. Diabetes Res Clin Pract. 2019 Apr;150:111-121. doi: 10.1016/j.diabres.2019.03.003. Epub 2019 Mar 4.