Systematic Evaluation of Continuous Glucose Monitoring Data

NCT03545178 | Completed

• 1 other identifier: 2018-00207
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 1

Brief Summary

This study retrospectively evaluates continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) data and pursues two main objectives: First, the investigators analyze if glucose values are better controlled in the days directly before a consultation at our tertiary referral centre (so called "white coat adherence"). Second, the investigators use the collected CGM and FGM data to develop a hypoglycemia prediction model.

Conditions

Diabetes Mellitus

Keywords

white coat adherence; continuous glucose monitoring; flash glucose monitoring; hypoglycemia prediction; deep learning algorithm

Outcome Measures

Primary Outcomes (2)

• Change of time in target glucose range day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

  The time spent in the target glucose range from 3.9 to 10.0 mmol/l assessed by CGM/FGM.

  01.01.2013 - 31.07.2018; outcome assessed at study end

• Hypoglycemia prediction (for Substudy B)

  Proportion of times a deep learning based algorithm can predict a hypoglycemic event (BG \<4.0 mmol/l) at least 20 min ahead in time?

  01.01.2013 - 31.07.2018; outcome assessed at study end

Secondary Outcomes (7)

• Change of time above and below glucose target range day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

  01.01.2013 - 31.07.2018; outcome assessed at study end

• Change of average and standard deviation glucose day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

  01.01.2013 - 31.07.2018; outcome assessed at study end

• Sensor wearing time day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

  01.01.2013 - 31.07.2018; outcome assessed at study end

• Change of coefficient of variation (CV) day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

  01.01.2013 - 31.07.2018; outcome assessed at study end

• Change of time in hypoglycemia day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

  01.01.2013 - 31.07.2018; outcome assessed at study end

Other Outcomes (4)

• Change of total, basal and bolus insulin dose day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

  01.01.2013 - 31.07.2018; outcome assessed at study end

• Change of periods with glucose below 3.0mmol/l for at least 15 minutes day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

  01.01.2013 - 31.07.2018; outcome assessed at study end

• Change of periods with glucose above 13.9mmol/l for at least 15 minutes day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

  01.01.2013 - 31.07.2018; outcome assessed at study end

Study Arms (1)

Diabetic patients using CGM/FGM

Evaluation of glucose control and application of hypoglycemia prediction models in diabetic patients wearing CGM and/or FGM devices for at least 50% of the time during the last 4 weeks prior to the medical consultation.

Behavioral: glucose control (Substudy A); Diagnostic Test: hypoglycemia prediction (Substudy B)

Interventions

glucose control (Substudy A) BEHAVIORAL

Comparison of glucose values during days 0 - 3 with days 4 - 28 and 0 - 7 with days 8 - 28 before a medical consultation at the diabetes clinic in patients suffering from diabetes and wearing a continuous glucose monitoring and/or flash glucose monitoring device

Diabetic patients using CGM/FGM

hypoglycemia prediction (Substudy B) DIAGNOSTIC_TEST

Use of CGM/FGM data to develop and evaluate a neural network based hypoglycemia prediction model

Diabetic patients using CGM/FGM

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients suffering from diabetes mellitus controlled at our tertiary referral centre using a CGM/FMG device for at least 50% of the time

You may qualify if:

• Diabetes mellitus
• CGM and/or FGM available for at least 50% of the time in last 4 weeks before consultation
• Written informed general consent for the retrospective analysis of data

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, Bern University Hospital, University of Bern

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Thomas Zueger, MD

  Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland

  PRINCIPAL INVESTIGATOR

• Christoph Stettler, Prof.

  Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: June 4, 2018
• Study Start: April 1, 2018
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

CH (1)