NCT04936633

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

10 months

First QC Date

May 24, 2021

Last Update Submit

October 22, 2022

Conditions

Type 1 Diabetes Mellitus

Keywords

Remote interventionFlash sensor-based glucose monitoringType 1 diabetes mellitusInsulin-dependent diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Changes in glycemic control measured by HbA1c

    Difference between baseline HbA1c and follow-up HbA1c

    3 months

Secondary Outcomes (18)

  • Changes in the time in range

    3 months

  • Changes in the duration of hyperglycemic episodes

    3 months

  • Changes in the duration of hypoglycemic episodes

    3 months

  • Changes in hypoglycemic episodes

    3 months

  • Changes in the mean glucose values

    3 months

  • +13 more secondary outcomes

Study Arms (2)

No intervention by medical staff

NO INTERVENTION

The patients who start FSGM and receive general education on FSGM only.

Intervention by medical staff based on a cloud system

EXPERIMENTAL

The patients who start FSGM and receive general education on FSGM and remote intervention based on a cloud system.

Other: Intervention by medical staff based on a cloud system

Interventions

Intervention by medical staff based on a cloud systemOTHER

Remote intervention by medical staff (between Visit 1 and Visit 2; Week 2, 4, 6, 8, 10) : analyzing continuous glucose monitoring data for last two weeks in the cloud system \- Intervention contents 1. Diet, exercise pattern 2. Causes of hypoglycemia 3. Causes of hyperglycemia 4. Causes of glycemic variability 5. Counseling for improvement plans for the cause 6. Counseling to strengthen lifestyle modification 7. Counseling for insulin administration 8. Counseling for Insulin dose adjustment (adjusted dose) 9. Counseling for how to use a FSGM

Intervention by medical staff based on a cloud system

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 32543683BACKGROUND

  • 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.

    PMID: 32543682BACKGROUND

  • 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.

    PMID: 30844467BACKGROUND

  • Lee J, Lee MH, Park J, Kim KS, Kim SK, Cho YW, Han HW, Song YS. FGM-based remote intervention for adults with type 1 diabetes: The FRIEND randomized clinical trial. Front Endocrinol (Lausanne). 2022 Nov 25;13:1054697. doi: 10.3389/fendo.2022.1054697. eCollection 2022.

    PMID: 36506077DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
A ssistant Professor

Study Record Dates

First Submitted

May 24, 2021

First Posted

June 23, 2021

Study Start

June 30, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

October 25, 2022

Record last verified: 2022-10

Locations

KR(1)