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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.
Diabetes in pregnancy is associated with increased risks of maternal and fetal complications and can be challenging to manage due to increasing insulin requirements with advancing gestational age. Based on standard of care guidelines, patients with diabetes check their blood glucose at least 4 times per day. Optimal management requires frequent glucose self-monitoring and active management of abnormal blood sugars and medications by clinicians. Poorly controlled diabetes has both significant maternal and neonatal consequences: Improving test adherence could benefit both the pregnant woman and her fetus. In this study, we propose to test the effect of two incentive schemes on rates of glucose monitoring on pregnant women with diabetes requiring medication.
Pregnant women with diabetes requiring medication are invited to participate if they meet specific inclusion criteria (<29 weeks) and followed in our outpatient clinic. Participants are randomized into one of three groups:
Primary outcome of the study is frequency of prescribed glucose testing in pregnancy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive incentive | Behavioral | Compensation is paid for each glucose test completed |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women eligible
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| Name | Affiliation | Role |
|---|---|---|
| Janet Andrews, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52246 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33345801 | Background | 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. | |
| 12683649 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | The control arm will receive $25.00 at time of enrollment for agreeing to participate. |
| FG001 | Positive Incentive | The positive incentive arm will receive $0.10 per prescribed test, payable every month based on testing adherence. For those with type 2 diabetes, the maximum daily payment will be $0.40. For those with type 1 diabetes , the maximum payment will be $0.70 per day. Positive incentive: Compensation is paid for each glucose test completed |
| FG002 | Loss Aversion | The loss aversion arm will have $100 deposited into a University of Iowa Women's Health account. The participant will then "lose" compensation depending on actual adherence to recommended testing. For 95% or more adherence, no money will be lost. For 85-94% adherence, $25 will be removed from account. For 70-84% adherence, $50 will be removed from account. For less than 69% adherence, $75 will be removed. Loss aversion: 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Positive Incentive | The positive incentive arm will receive compensation per prescribed test, payable every month based on testing adherence. Positive incentive: Compensation is paid for each glucose test completed |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Error | percentage of overall adherence | Pregnancy |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | The control arm will receive compensation at time of enrollment for agreeing to participate. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah A. Wernimont MD, PhD | University of Minnesota | 612-301-3408 | swernimo@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2022 | Mar 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| Loss aversion | Behavioral | 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 |
|
| 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. |
| 7565999 | Background | 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. |
| 25970009 | Background | 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. |
| 24522623 | Background | 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. |
| 26320923 | Background | 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. |
| 22227223 | Background | 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. |
| 28724718 | Background | 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. |
| 25627664 | Background | 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. |
| 35777732 | Derived | 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. |
| Protocol Violation |
|
The control arm will receive compensation at time of enrollment for agreeing to participate.
| BG002 | Loss Aversion | 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 Loss aversion: 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Self-reported in electronic health record | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
The positive incentive arm will receive compensation per prescribed test, payable every month based on testing adherence. Positive incentive: Compensation is paid for each glucose test completed |
| OG002 | Loss Aversion | 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 Loss aversion: 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 |
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Positive Incentive | Positive incentive: Compensation is paid for each glucose test completed | 0 | 39 | 0 | 39 | 0 | 39 |
| EG002 | Loss Aversion | Loss aversion: 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 | 0 | 41 | 0 | 41 | 0 | 41 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |