Type 2 Diabetes and Pregnancy a Single-arm Interventional Study (pUMPreg2)
2026年5月15日 更新者：Poznan University of Medical Sciences
This single-arm interventional study evaluates the MiniMed 780G insulin pump and continuous glucose monitoring (CGM) system in pregnant women with type 2 diabetes enrolled at ≤ 16 weeks gestation.
From recruitment to delivery, participants attend regular clinical visits for active insulin adjustments.
The primary objective is to measure the percentage of time spent in the target pregnancy glucose range (63-140 mg/dL).
Secondary outcomes track mean glucose, HbA1c, and overall maternal and neonatal health to ensure safety and efficacy.
調査の概要
詳細な説明
This study will evaluate the use of the MiniMed 780G insulin pump system in pregnant women with type 2 diabetes. The aim is to assess whether this treatment can help participants achieve good glucose control during pregnancy and support favorable maternal and neonatal outcomes.
This is a single-arm interventional study. All participants will use the same insulin pump and continuous glucose monitoring system from recruitment until delivery. The study will include pregnant women with type 2 diabetes who enter the study at 16 weeks of pregnancy or less.
Participants will attend regular follow-up visits during pregnancy. Researchers will review glucose data, adjust insulin treatment, measure HbA1c, and assess pregnancy and neonatal outcomes.
The main outcome is the percentage of time spent in the pregnancy target glucose range of 63 to 140 mg/dL from recruitment until delivery. The study will also assess mean glucose levels, maternal outcomes, and neonatal outcomes.
This study will evaluate the use of the MiniMed 780G insulin pump system in pregnant women with type 2 diabetes. The aim is to assess whether this treatment can help participants achieve good glucose control during pregnancy and support favorable maternal and neonatal outcomes.
This is a single-arm interventional study. All participants will use the same insulin pump and continuous glucose monitoring system from recruitment until delivery. The study will include pregnant women with type 2 diabetes who enter the study at 16 weeks of pregnancy or less.
Participants will attend regular follow-up visits during pregnancy. Researchers will review glucose data, adjust insulin treatment, measure HbA1c, and assess pregnancy and neonatal outcomes.
The main outcome is the percentage of time spent in the pregnancy target glucose range of 63 to 140 mg/dL from recruitment until delivery. The study will also assess mean glucose levels, maternal outcomes, and neonatal outcomes.
研究の種類
介入
入学 (推定)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ewa Wender-Ozegowska, Prof. MD PhD
- 電話番号：+48 (61) 841-93-02
- メール：ewozegow@ump.edu.pl
研究場所
-
-
Wielkopolska
-
Poznan、Wielkopolska、ポーランド、60-535
- Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Medical Sciences
-
コンタクト：
- Ewa Wender-Ozegowska, Prof. MD PhD
- 電話番号：+48 (61) 841-93-02
- メール：ewozegow@ump.edu.pl
-
主任研究者：
- Ewa Wender-Ozegowska, Prof. MD PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Women with diagnosed pregestational type 2 diabetes or HbA1c >6.5% in the 1st trimester (ADA, PTD)
- Age 18-45 years
- Gestational age of 16 weeks +0 days or less at baseline
- Singleton pregnancy
- HbA1c at baseline 5.0-10%
- A viable pregnancy at the recruitment
- Willingness to continue the treatment until delivery in the clinic
Exclusion Criteria:
- Other types of diabetes including T1D and Monogenic diabetes
- Major fetal congenital defects
- Severe nephropathy, psychiatric illness or other serious medical disorder that in the judgment of the investigator could affect completion of the trial
- Pump therapy before pregnancy
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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：Type 2 diabetes
Pregnant patients with type 2 diabetes treated with automated insulin delivery system
|
Use of automated insulin delivery system in pregnant patients with type 2 diabetes
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time in range
時間枠：From enrollment to the delivery
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
From enrollment to the delivery
|
|
Mean sensor glycemia
時間枠：From enrollment to the delivery
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
From enrollment to the delivery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time in range
時間枠：Week 18
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 18
|
|
Time in range
時間枠：Week 22
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 22
|
|
Time in range
時間枠：Week 26
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 26
|
|
Time in range
時間枠：Week 30
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 30
|
|
Time in range
時間枠：Week 34
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 34
|
|
Time in range
時間枠：Week 37
|
Percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
Week 37
|
|
Time in tight range
時間枠：Week 18
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 18
|
|
Time in tight range
時間枠：Week 22
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 22
|
|
Time in tight range
時間枠：Week 26
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 26
|
|
Time in tight range
時間枠：Week 30
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 30
|
|
Time in tight range
時間枠：Week 34
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 34
|
|
Time in tight range
時間枠：Week 37
|
Percentage of time spent in target glucose values - 63-120 mg/dL (3.5-6.7 mmol/L)
|
Week 37
|
|
Change in the time in range values
時間枠：From the recruitment to delivery
|
Change in percentage of time spent in target glucose values - 63-140 mg/dL (3.5-7.8 mmol/L)
|
From the recruitment to delivery
|
|
Time above range
時間枠：Week 18
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 18
|
|
Time above range
時間枠：Week 22
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 22
|
|
Time above range
時間枠：Week 26
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 26
|
|
Time above range
時間枠：Week 30
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 30
|
|
Time above range
時間枠：Week 34
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 34
|
|
Time above range
時間枠：Week 37
|
Percentage of time spent above target glucose values - >140 mg/dL (>7.8 mmol/L)
|
Week 37
|
|
Time above tight range
時間枠：Week 18
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 18
|
|
Time above tight range
時間枠：Week 22
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 22
|
|
Time above tight range
時間枠：Week 26
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 26
|
|
Time above tight range
時間枠：Week 30
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 30
|
|
Time above tight range
時間枠：Week 34
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 34
|
|
Time above tight range
時間枠：Week 37
|
Percentage of time spent above target glucose values - >120 mg/dL (>6.7 mmol/L)
|
Week 37
|
|
Time below range
時間枠：Week 18
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 18
|
|
Time below range
時間枠：Week 22
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 22
|
|
Time below range
時間枠：Week 26
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 26
|
|
Time below range
時間枠：Week 30
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 30
|
|
Time below range
時間枠：Week 34
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 34
|
|
Time below range
時間枠：Week 37
|
Percentage of time spent below target glucose values - <63 mg/dL (<3.5 mmol/L)
|
Week 37
|
|
Mean sensor glycemia
時間枠：Week 18
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 18
|
|
Mean sensor glycemia
時間枠：Week 22
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 22
|
|
Mean sensor glycemia
時間枠：Week 26
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 26
|
|
Mean sensor glycemia
時間枠：Week 30
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 30
|
|
Mean sensor glycemia
時間枠：Week 34
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 34
|
|
Mean sensor glycemia
時間枠：Week 37
|
Average value of glucose concentration measured by the sensor (mg/dL and mmol/L)
|
Week 37
|
|
Coefficient of variation (%CV)
時間枠：Week 18
|
Metric of glycemic variability measured by the sensor (%)
|
Week 18
|
|
Coefficient of variation (%CV)
時間枠：Week 22
|
Metric of glycemic variability measured by the sensor (%)
|
Week 22
|
|
Coefficient of variation (%CV)
時間枠：Week 26
|
Metric of glycemic variability measured by the sensor (%)
|
Week 26
|
|
Coefficient of variation (%CV)
時間枠：Week 30
|
Metric of glycemic variability measured by the sensor (%)
|
Week 30
|
|
Coefficient of variation (%CV)
時間枠：Week 34
|
Metric of glycemic variability measured by the sensor (%)
|
Week 34
|
|
Coefficient of variation (%CV)
時間枠：Week 37
|
Metric of glycemic variability measured by the sensor (%)
|
Week 37
|
|
Standard deviation (SD)
時間枠：Week 18
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 18
|
|
Standard deviation (SD)
時間枠：Week 22
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 22
|
|
Standard deviation (SD)
時間枠：Week 26
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 26
|
|
Standard deviation (SD)
時間枠：Week 30
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 30
|
|
Standard deviation (SD)
時間枠：Week 34
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 34
|
|
Standard deviation (SD)
時間枠：Week 37
|
Metric of glycemic variability measured by the sensor (mg/dL and mmol/L)
|
Week 37
|
|
HbA1C
時間枠：Week 18
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 18
|
|
HbA1C
時間枠：Week 22
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 22
|
|
HbA1C
時間枠：Week 26
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 26
|
|
HbA1C
時間枠：Week 30
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 30
|
|
HbA1C
時間枠：Week 34
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 34
|
|
HbA1C
時間枠：Week 37
|
Blood glycated hemoglobin measurement (% and mmol/mol)
|
Week 37
|
|
Severe hypoglycemia episodes
時間枠：From recruitment until delivery.
|
Number of episodes of self-reported severe hypoglycemia.
|
From recruitment until delivery.
|
|
Gestational weight gain
時間枠：From recruitment until delivery
|
Maternal gestational weight gain (kg)
|
From recruitment until delivery
|
|
Gestational weight gain from pre-pregnancy
時間枠：From pre-pregnancy until delivery
|
Self-reported maternal gestational weight gain (kg)
|
From pre-pregnancy until delivery
|
|
Pregnancy hypertensive disorders
時間枠：From recruitment until delivery
|
Preeclampsia, Eclampsia, Gestational hypertension
|
From recruitment until delivery
|
|
The mode of delivery
時間枠：At delivery
|
Vaginal, c-section, spontaneous, induction of labor
|
At delivery
|
|
Birth trauma
時間枠：At delivery
|
IADPSG criteria
|
At delivery
|
|
Gestational birth weight
時間枠：At delivery
|
Neonatal birth weight in grams
|
At delivery
|
|
Macrosomia
時間枠：At delivery
|
Gestational birth weight >4200g
|
At delivery
|
|
Large-for-gestational-age (LGA)
時間枠：At delivery
|
Neonatal birth weight >90th percentile
|
At delivery
|
|
Small-for-gestational-age (SGA)
時間枠：At delivery
|
Neonatal birth weight >10th percentile
|
At delivery
|
|
Placental weight
時間枠：At delivery
|
Measured in grams
|
At delivery
|
|
Gestational age
時間枠：At delivery
|
Timing of delivery
|
At delivery
|
|
Preterm birth
時間枠：At delivery
|
<37 weeks
|
At delivery
|
|
Number of neonates with respiratory distress syndrome
時間枠：From delivery until hospital discharge, assessed up to 20 weeks postpartum
|
Defined as the number of neonates diagnosed with respiratory distress syndrome during the postnatal hospital stay, based on clinical signs of respiratory distress and the need for respiratory support, with or without radiological confirmation, according to local neonatal clinical practice.
|
From delivery until hospital discharge, assessed up to 20 weeks postpartum
|
|
Number of neonates with jaundice requiring phototherapy
時間枠：From delivery until hospital discharge, assessed up to 20 weeks postpartum
|
Defined as the number of neonates diagnosed with neonatal jaundice requiring phototherapy during the postnatal hospital stay.
Phototherapy requirement will be determined according to local neonatal clinical practice based on serum or transcutaneous bilirubin assessment.
|
From delivery until hospital discharge, assessed up to 20 weeks postpartum
|
|
Number of neonates with neonatal hypoglycemia
時間枠：Assessed from delivery until 24 hours postpartum
|
Neonatal hypoglycemia - glucose concentrations in neonatal blood <40 mg/dL (2.2 mmol/L) in a single laboratory measurement at least 3 hours after birth, in the first 24 hours of life
|
Assessed from delivery until 24 hours postpartum
|
|
Stillbirth
時間枠：From week 22
|
Pregnancy loss after 22 weeks
|
From week 22
|
|
Neonatal length of hospital stay
時間枠：From date of delivery until the date of hospital discharge, assessed up to 20 weeks
|
Duration of neonatal hospitalization, measured in days
|
From date of delivery until the date of hospital discharge, assessed up to 20 weeks
|
|
Length of stay in the neonatal intensive care unit (NICU)
時間枠：From date of NICU admission until the date of NICU discharge, assessed up to 20 weeks
|
Duration of NICU stay, measured in days
|
From date of NICU admission until the date of NICU discharge, assessed up to 20 weeks
|
|
Neonatal acidosis
時間枠：At delivery
|
Umbilical pH <7.15
|
At delivery
|
|
Apgar score
時間枠：At delivery
|
Apgar score <8
|
At delivery
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：Ewa Wender-Ozegowska, Prof. MD PhD、Poznan University of Medical Sciences
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Gladych-Macioszek A, Mantaj U, Tobola-Wrobel K, Radzicka-Mularczyk S, Sibiak R, Adamczak L, Desoye G, Wender-Ozegowska E. Early gestational diabetes mellitus and type 2 diabetes: do they differ in perinatal outcome- a retrospective analysis. BMC Pregnancy Childbirth. 2026 Mar 11;26(1):423. doi: 10.1186/s12884-026-08927-3.
- Sibiak R, Iciek R, Gastolek K, Chudzynska E, Meek C, Wender-Ozegowska E. Ten-year national trends in the prevalence and outcomes of gestational diabetes mellitus in Poland: a population-based study. Pol Arch Intern Med. 2026 Feb 26;136(2):17202. doi: 10.20452/pamw.17202. Epub 2026 Jan 19.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月1日
一次修了 (推定)
2028年10月1日
研究の完了 (推定)
2029年2月1日
試験登録日
最初に提出
2026年5月6日
QC基準を満たした最初の提出物
2026年5月15日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月22日
QC基準を満たした最後の更新が送信されました
2026年5月15日
最終確認日
2026年5月1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。