NCT03338829

Brief Summary

Diabetes in pregnancy carries significant pregnancy specific risks and requires frequent glucose monitoring to reduce these risks. This project compares the effect of two incentive schemes on adherence rates of glucose testing in pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 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

Study Start

First participant enrolled

May 5, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2019

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

July 30, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

3.6 years

First QC Date

October 26, 2017

Results QC Date

June 16, 2022

Last Update Submit

July 10, 2025

Conditions

Diabetes in Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Frequency of Glucose Monitoring

    Patients with type 1 diabetes were advised to monitor glucose seven times daily (fasting, 1hour post breakfast, pre- lunch, 1 hour post lunch, pre-dinner and 1 hour post dinner and nightly). Patients with type 2 and gestational diabetes were advised to have four glucose tests daily (fasting and 1hour post breakfast, lunch and dinner). Adherence to glucose testing was determined by the number of tests daily divided by the # of recommended tests daily and averaged over the course of the study as previously described

    Pregnancy

Study Arms (3)

Control

NO INTERVENTION

The control arm will receive compensation at time of enrollment for agreeing to participate.

Positive Incentive

EXPERIMENTAL

The positive incentive arm will receive compensation per prescribed test, payable every month based on testing adherence.

Behavioral: Positive incentive

Loss Aversion

EXPERIMENTAL

The loss aversion arm will have compensation deposited into a University of Iowa Women's Health account. The participant will then "lose" compensation depending on actual adherence to recommended testing

Behavioral: Loss aversion

Interventions

Positive incentiveBEHAVIORAL

Compensation is paid for each glucose test completed

Positive Incentive
Loss aversionBEHAVIORAL

Fixed compensation is offered to patients and they can earn a range of compensation at the completion of pregnancy depending on overall glucose testing adherence

Loss Aversion

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women eligible
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women with insulin dependent diabetes prior to 29 weeks gestation.

You may not qualify if:

  • incarcerated, not English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52246, United States

Location

Related Publications (10)

  • Wernimont SA, Sheng JS, Tymkowicz A, Fleener DK, Summers KM, Syrop CH, Andrews JI. Adherence to self-glucose monitoring recommendations and perinatal outcomes in pregnancies complicated by diabetes mellitus. Am J Obstet Gynecol MFM. 2019 Aug;1(3):100031. doi: 10.1016/j.ajogmf.2019.100031. Epub 2019 Aug 5.

    PMID: 33345801BACKGROUND

  • Homko CJ, Reece EA. Self-monitoring of blood glucose in gestational diabetes. J Matern Fetal Neonatal Med. 2002 Dec;12(6):389-95. doi: 10.1080/jmf.12.6.389.395.

    PMID: 12683649BACKGROUND

  • de Veciana M, Major CA, Morgan MA, Asrat T, Toohey JS, Lien JM, Evans AT. Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy. N Engl J Med. 1995 Nov 9;333(19):1237-41. doi: 10.1056/NEJM199511093331901.

    PMID: 7565999BACKGROUND

  • Halpern SD, French B, Small DS, Saulsgiver K, Harhay MO, Audrain-McGovern J, Loewenstein G, Brennan TA, Asch DA, Volpp KG. Randomized trial of four financial-incentive programs for smoking cessation. N Engl J Med. 2015 May 28;372(22):2108-17. doi: 10.1056/NEJMoa1414293. Epub 2015 May 13.

    PMID: 25970009BACKGROUND

  • Sen AP, Sewell TB, Riley EB, Stearman B, Bellamy SL, Hu MF, Tao Y, Zhu J, Park JD, Loewenstein G, Asch DA, Volpp KG. Financial incentives for home-based health monitoring: a randomized controlled trial. J Gen Intern Med. 2014 May;29(5):770-7. doi: 10.1007/s11606-014-2778-0. Epub 2014 Feb 13.

    PMID: 24522623BACKGROUND

  • Yee LM, McGuire JM, Taylor SM, Niznik CM, Simon MA. "I Was Tired of All the Sticking and Poking": Identifying Barriers to Diabetes Self-Care Among Low-Income Pregnant Women. J Health Care Poor Underserved. 2015 Aug;26(3):926-40. doi: 10.1353/hpu.2015.0073.

    PMID: 26320923BACKGROUND

  • Higgins ST, Washio Y, Heil SH, Solomon LJ, Gaalema DE, Higgins TM, Bernstein IM. Financial incentives for smoking cessation among pregnant and newly postpartum women. Prev Med. 2012 Nov;55 Suppl(Suppl):S33-40. doi: 10.1016/j.ypmed.2011.12.016. Epub 2011 Dec 27.

    PMID: 22227223BACKGROUND

  • Cosson E, Baz B, Gary F, Pharisien I, Nguyen MT, Sandre-Banon D, Jaber Y, Cussac-Pillegand C, Banu I, Carbillon L, Valensi P. Poor Reliability and Poor Adherence to Self-Monitoring of Blood Glucose Are Common in Women With Gestational Diabetes Mellitus and May Be Associated With Poor Pregnancy Outcomes. Diabetes Care. 2017 Sep;40(9):1181-1186. doi: 10.2337/dc17-0369. Epub 2017 Jul 19.

    PMID: 28724718BACKGROUND

  • Tappin D, Bauld L, Purves D, Boyd K, Sinclair L, MacAskill S, McKell J, Friel B, McConnachie A, de Caestecker L, Tannahill C, Radley A, Coleman T; Cessation in Pregnancy Incentives Trial Team. Financial incentives for smoking cessation in pregnancy: randomised controlled trial. BMJ. 2015 Jan 27;350:h134. doi: 10.1136/bmj.h134.

    PMID: 25627664BACKGROUND

  • Wernimont SA, Fleener D, Summers KM, Deonovic B, Syrop CH, Andrews JI. The Effect of Financial Incentives on Adherence to Glucose Self-Monitoring during Pregnancy among Patients with Insulin-Requiring Diabetes: A Randomized Clinical Trial. Am J Perinatol. 2024 May;41(S 01):e259-e266. doi: 10.1055/a-1889-7765. Epub 2022 Jul 1.

    PMID: 35777732DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Sarah A. Wernimont MD, PhD
Organization
University of Minnesota
swernimo@umn.edu
612-301-3408

Study Officials

  • Janet Andrews, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2017

First Posted

November 9, 2017

Study Start

May 5, 2016

Primary Completion

December 18, 2019

Study Completion

June 30, 2022

Last Updated

July 30, 2025

Results First Posted

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)