Investigating Novel Predictions of Hypoglycemia Occurrence in Real-world Models

NCT04219514 | Completed

• 1 other identifier: 112986
• Study Type: observational
• Target: 1,206
• Locations: 1 country
• Sites: 1

Brief Summary

Hypoglycemia is the most common diabetes-related adverse event. However, it is often under-reported to healthcare providers by patients and simultaneously, not often asked about by healthcare providers. As a result, little is known about how often hypoglycemia occurs and consequently, which individuals with diabetes will experience such events. The aims of this study are to determine the real- world occurrence of hypoglycemia and develop/validate real-world risk prediction models for hypoglycemia. These risk prediction models will generate a risk score that indicates an individual's risk for hypoglycemia given their socio-demographic, clinical, and/or behaviour-related characteristics. They can be used to promote clinician awareness around patients' hypoglycemia risks, guide point- of-care and patient decision-making with regard to treatment changes, inform the development and conduct of population-based interventions, and lead to tailored, cost-effective management strategies.

Conditions

Hypoglycemia; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Keywords

hypoglycemia; diabetes mellitus

Outcome Measures

Primary Outcomes (2)

• Incidence proportions and densities of severe hypoglycemia, non-severe daytime hypoglycemia, and non-severe nighttime hypoglycemia

  Self-reported through questionnaires

  Up to 12 months prospectively

• Risk scores for severe hypoglycemia, non-severe daytime hypoglycemia, non-severe nighttime hypoglycemia

  Investigating Novel Predictions of Hypoglycemia Occurrence Using Real-World Models (iNPHORM) Hypoglycemia Risk Score: Risk scores using the probabilities (0-100%) from our validated multivariable prediction models will be calculated to reflect the degree of risk due to the candidate variables (low to high risk scores will denote low to high risks of hypoglycemia occurrence, respectively). Any selected ranges of predicted probabilities used as boundaries for risk stratification will be justified. Details relevant to the calculation of subject-specific risks will be reported, including the intercepts and betas from the logistic regression models and nomograms.

  Up to 12 months prospectively

Secondary Outcomes (1)

• Exploratory causal estimates of different treatment regimens and hypoglycemia rates

  Up to 12 months prospectively

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited into the pilot test and the observational cohort of the study from a pre-existing online panel representative of the general public developed and managed by Ipsos Interactive Services (IIS), a global leader in survey conduct. Within the USA, IIS and its subsidiary partners manage a nationwide panel of 65,000+ people with diabetes (\~10,000 with T1DM and \~58,000 with T2DM); this panel will serve as the sampling frame for the current investigation. All individuals in the pre-existing online panel provided profile information and consented to be approached by IIS and its subsidiary partners to complete surveys. For this study, individuals approached to participate in the pilot tests will not subsequently be invited to participate in the observational cohort.

You may qualify if:

• Self-reported diagnosis of T1DM or T2DM
• Use of insulin and/or secretagogues for at least one year at the time of enrolment
• Living in the United States of America for at least one year at the time of enrolment

You may not qualify if:

• Unable to read and understand English
• Currently pregnant or pregnant within the previous year
• Currently participating in an interventional clinical trial or research study

Sponsors & Collaborators

• Stewart Harris: lead
• Sanofi: collaborator

Study Sites (1)

Ipsos

New York, New York, 10010, United States

Location

Related Publications (3)

• Ratzki-Leewing A, Black JE, Ryan BL, Harris SB. Real-world risk factors of confirmed or probable COVID-19 in Americans with diabetes: A prospective, community-based study (iNPHORM). Endocrinol Diabetes Metab. 2022 Jul;5(4):e342. doi: 10.1002/edm2.342. Epub 2022 May 29.

  PMID: 35644866 DERIVED

• Ratzki-Leewing A, Ryan BL, Zou G, Webster-Bogaert S, Black JE, Stirling K, Timcevska K, Khan N, Buchenberger JD, Harris SB. Predicting Real-world Hypoglycemia Risk in American Adults With Type 1 or 2 Diabetes Mellitus Prescribed Insulin and/or Secretagogues: Protocol for a Prospective, 12-Wave Internet-Based Panel Survey With Email Support (the iNPHORM [Investigating Novel Predictions of Hypoglycemia Occurrence Using Real-world Models] Study). JMIR Res Protoc. 2022 Feb 11;11(2):e33726. doi: 10.2196/33726.

  PMID: 35025756 DERIVED

• Ratzki-Leewing AA, Ryan BL, Buchenberger JD, Dickens JW, Black JE, Harris SB. COVID-19 hinterland: surveilling the self-reported impacts of the pandemic on diabetes management in the USA (cross-sectional results of the iNPHORM study). BMJ Open. 2021 Sep 2;11(9):e049782. doi: 10.1136/bmjopen-2021-049782.

  PMID: 34475174 DERIVED

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Stewart Harris, MD MPH

  Western University

  PRINCIPAL INVESTIGATOR

• Alexandria Ratzki-Leewing, PhD(c) MSc

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 7, 2020
• Study Start: February 10, 2020
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)