A Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control
A Randomized, Controlled, Open-label, Multi-center Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control
The benefit of drug therapy to persons with diabetes has been well established in clinical trials in terms of reducing cardiovascular risk, microvascular complications and mortality. However, treatment adherence and treatment effectiveness continue to be challenges in diabetes management.
Rimidi Diabetes has developed software algorithms to simulate the effect of anti-diabetic medications on an individual's glucose profile, allowing the clinician and their patient to visualize the anticipated outcome of a medical intervention. Use of this technology should allow for more targeted decision-making by the clinician and should facilitate a shared decision-making process with the PwD who is now privy to the thought process behind their medical management.
The proposed study is designed to test whether adding a decision support capability (Diabetes+Me Rx) that allows for modeling the anticipated effect of medication adjustments leads to improved glycemic control and a perceived benefit by healthcare providers and PwDs.
調査の概要
詳細な説明
Recruitment
- Recruitment of persons with diabetes through a community diabetes management center according to inclusion and exclusion criteria below.
- This is a three-armed study. Enrollees will be randomized to continue diabetes care with standard diabetes management in the Medication Management Clinic or the Intervention Group and compared to a matched cohort managed through their primary care physician (PCP) and standard of care.
- The Intervention Group will be standard diabetes management in the Medication Management Clinic plus the use of Diabetes+Me with a connected glucometer.
- Upon recruitment, PwD will be oriented to the Diabetes+Me application and instructed on how to complete a glucose profile and how to enter data into the application. Baseline hemoglobin A1C will be measured.
- Enrollees will complete a brief survey of satisfaction with their diabetes management.
Study visits
- The first study visit will be 2 weeks following enrollment.
- Weight, number of medications, number of medication titrations, the presence of insulin and blood pressure will be measured at each study visit. Frequency of hypoglycemia in the preceding week will be documented at each visit. Adherence to medical prescription to be documented at each visit.
- If the PwD has not entered data into Diabetes+Me this will be done at the beginning of each study visit.
- At the first study visit, the HCP will review the glucose profile from the previous week, identify areas where the PwD is not meeting targets and model adjustments to their medications to achieve the desired anticipated effect. If indicated, a new prescription will be issued and the PwD instructed to collect a new glucose profile the week preceding the next visit.
- The second study visit will occur 5 weeks following the initial visit. The HCP and PwD will review the glucose profile from the previous week, identify areas where the PwD is not meeting targets and model adjustments to their medications to achieve the desired anticipated effect. If indicated, a new prescription will be issued and the PwD instructed to collect a new glucose profile the week preceding the final visit.
The third and final study visit will occur 5 weeks following the second visit. The HCP and PwD will review the glucose profile from the previous week and identify if the PwD is meeting targets.
研究の種類
入学 (予想される)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Physician diagnosis of type 1 or type 2 diabetes
- Glycated hemoglobin > 9% within 3 months
- Age 18-80
- Not currently managed by study clinicians
Exclusion Criteria:
- Pregnant
- Active substance abuse
- Severe hearing or visual impairment
- No internet or email access
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention Group
Patient in standard diabetes management in the Medication Management Clinic plus the use of Diabetes+Me plus connected glucometer
|
referral to medication management clinic from primary care
Use of software and medication modeling tool as add on to medication management standard of care
|
|
アクティブコンパレータ：Standard Diabetes Management
Patient in standard diabetes management in the Medication Management Clinic
|
referral to medication management clinic from primary care
|
|
介入なし：Primary Care
Matched cohort managed through their primary care physician (PCP) and standard of care.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Hemoglobin A1C
時間枠：change from baseline to 12 weeks
|
change from baseline to 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of hypoglycemic events per week
時間枠：change from 1st week to twelfth week
|
Decrease in frequency of hypoglycemia (# events per week
|
change from 1st week to twelfth week
|
|
Blood pressure
時間枠：change from baseline to 12 weeks
|
increase in percentage of patients with blood pressure in normotensive range
|
change from baseline to 12 weeks
|
|
BMI
時間枠：change from baseline to 12 weeks
|
decrease in BMI
|
change from baseline to 12 weeks
|
|
Healthcare provider satisfaction
時間枠：through study completion, an average of 1 year
|
healthcare provider satisfaction based on scoring of questionnaire
|
through study completion, an average of 1 year
|
|
A1C target attainment
時間枠：at 12 weeks
|
time to A1c goal attainment
|
at 12 weeks
|
|
Medication titrations needed
時間枠：12 weeks
|
number of medication titrations over 12 week period needed to reach A1c goal
|
12 weeks
|
|
Patient satisfaction questionnaire
時間枠：through patient study completion, an average of 12 weeks
|
questionnaire addresses satisfaction with care and knowledge of diabetes self-management
|
through patient study completion, an average of 12 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Michael Jardula, MD、Desert Oasis Healthcare
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。