CGM Precision and Glycaemic Variability

NCT03842683 | Completed Results

• 1 other identifier: sdcn1802
• Study Type: observational
• Target: 472
• Locations: 0 countries
• Sites: N/A

Brief Summary

Use of devices for continuous monitoring of the blood sugar is valuable for people with diabetes to understand their disease and to help prevent low blood sugar. Furthermore, continuous monitoring should be used in drug development to evaluate efficacy and safety. However, the devices have been criticised for being too inaccurate. This investigation sought to reveal the inaccuracies of current devices and to assess the subsequent usability related to the mentioned use cases.

Conditions

Diabetes Type 1

Outcome Measures

Primary Outcomes (1)

• Optimal Time Shift of Continuous Glucose Monitoring Measurements

  Continuous glucose monitoring (CGM) measurements are delayed compared to blood glucose. The CGM signal is time-shifted -1 minute at a time and the mean absolute difference between CGM and blood glucose measurements are calculated at each step. The lowest mean absolute difference depicts the optimal time shift in minutes. The resultant mean absolute relative difference is provided as outcome. Publication reference: https://doi.org/10.1177/1932296819848721

  16 weeks

Secondary Outcomes (1)

• Area Under the Receiver Operating Characteristics Curve of the Hypoglycemia Prediction

  16 weeks

Interventions

CGM OTHER

This study seeks to assess CGM accuracy and develop prediction models for hypoglycemia detection and no intervention is therefore applied.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with type 1 diabetes

You may qualify if:

• Male or female, age at least 18 years at the time of signing the informed consent
• Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening
• Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.)
• HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening
• Body mass index (BMI) below or equal to 35.0 kg/m\^2 at screening
• Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial

You may not qualify if:

• Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
• Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
• History of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening
• Any condition which, in the opinion of the Investigator, might jeopardise a Subject's safety or compliance with the protocol

Sponsors & Collaborators

• Peter Vestergaard: lead

Related Publications (7)

• Rodbard D. Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes. Diabetes Technol Ther. 2017 Jun;19(S3):S25-S37. doi: 10.1089/dia.2017.0035.

  PMID: 28585879 BACKGROUND

• Jensen MH, Christensen TF, Tarnow L, Seto E, Dencker Johansen M, Hejlesen OK. Real-time hypoglycemia detection from continuous glucose monitoring data of subjects with type 1 diabetes. Diabetes Technol Ther. 2013 Jul;15(7):538-43. doi: 10.1089/dia.2013.0069. Epub 2013 Apr 30.

  PMID: 23631608 BACKGROUND

• Jensen MH, Christensen TF, Tarnow L, Mahmoudi Z, Johansen MD, Hejlesen OK. Professional continuous glucose monitoring in subjects with type 1 diabetes: retrospective hypoglycemia detection. J Diabetes Sci Technol. 2013 Jan 1;7(1):135-43. doi: 10.1177/193229681300700116.

  PMID: 23439169 BACKGROUND

• El-Khatib FH, Balliro C, Hillard MA, Magyar KL, Ekhlaspour L, Sinha M, Mondesir D, Esmaeili A, Hartigan C, Thompson MJ, Malkani S, Lock JP, Harlan DM, Clinton P, Frank E, Wilson DM, DeSalvo D, Norlander L, Ly T, Buckingham BA, Diner J, Dezube M, Young LA, Goley A, Kirkman MS, Buse JB, Zheng H, Selagamsetty RR, Damiano ER, Russell SJ. Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial. Lancet. 2017 Jan 28;389(10067):369-380. doi: 10.1016/S0140-6736(16)32567-3. Epub 2016 Dec 20.

  PMID: 28007348 BACKGROUND

• Rebrin K, Sheppard NF Jr, Steil GM. Use of subcutaneous interstitial fluid glucose to estimate blood glucose: revisiting delay and sensor offset. J Diabetes Sci Technol. 2010 Sep 1;4(5):1087-98. doi: 10.1177/193229681000400507.

  PMID: 20920428 BACKGROUND

• Kovatchev BP, Patek SD, Ortiz EA, Breton MD. Assessing sensor accuracy for non-adjunct use of continuous glucose monitoring. Diabetes Technol Ther. 2015 Mar;17(3):177-86. doi: 10.1089/dia.2014.0272. Epub 2014 Dec 1.

  PMID: 25436913 BACKGROUND

• Danne T, Nimri R, Battelino T, Bergenstal RM, Close KL, DeVries JH, Garg S, Heinemann L, Hirsch I, Amiel SA, Beck R, Bosi E, Buckingham B, Cobelli C, Dassau E, Doyle FJ 3rd, Heller S, Hovorka R, Jia W, Jones T, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Maahs D, Murphy HR, Norgaard K, Parkin CG, Renard E, Saboo B, Scharf M, Tamborlane WV, Weinzimer SA, Phillip M. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017 Dec;40(12):1631-1640. doi: 10.2337/dc17-1600.

  PMID: 29162583 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Morten Hasselstrøm Jensen
• Organization: Steno Diabetes Center North Denmark

mhj@hst.aau.dk

+4522226964

Study Officials

• Peter Vestergaard, PhD

  Steno Diabetes Center North Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: June 6, 2016
• Primary Completion: June 20, 2017
• Study Completion: June 20, 2017
• Last Updated: November 20, 2019
• Results First Posted: November 20, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share